Estudio primario

No clasificado

Safety and efficacy comparison of emedastine 0.05% ophthalmic solution compared to levocabastine 0.05% ophthalmic suspension in pediatric subjects with allergic conjunctivitis. Emadine Study Group.

Año 2000
Revista Acta ophthalmologica Scandinavica. Supplement
Enlaces DOI , Pubmed

Este artículo está incluido en 1 Revisión sistemática Revisiones sistemáticas (1 referencia)

Cargando información sobre las referencias
Mostrar resumen

PURPOSE:

To determine the efficacy and tolerance of emedastine 0.05% ophthalmic solution compared to levocabastine 0.05% ophthalmic suspension in pediatric subjects.

METHODS AND MATERIALS:

In a randomized, double-masked, parallel controlled study, emedastine 0.05% ophthalmic solution BID was compared to levocabastine 0.05% ophthalmic suspension BID, for control of the signs and symptoms of allergic conjunctivitis in pediatric subjects ages 3-16. Subjects who met all inclusion and exclusion criteria received masked study medication with instructions to instill drops twice daily, in the morning and evening. A diary was completed by the parents four times daily for the first two and last two weeks of the study. Treatment lasted 42 days. Drug efficacy was assessed at the initial administration in the office at Day 0 and after 3, 7, 14, 30 and 42 days.

RESULTS:

Overall results showed both drugs have an effect and that emedastine was significantly superior (p < 0.05) to levocabastine for the relief of chemosis on Days 14, 30 and 42; of itching on follow-up Days 30 and 42 (p < 0.05); of redness on Days 30 and 42; for eyelid swelling on Days 14 and 30; and for physician's impression score on Days 7, 14, 30 and 42.

CONCLUSION:

These results confirm previous preclinical and clinical data on the potent and long acting efficacy of this promising new ophthalmic anti-allergic drug, emedastine in pediatric subjects.

Mostrar resumen

Estudio primario

No clasificado

An efficacy and tolerance comparison of emedastine difumarate 0.05% and levocabastine hydrochloride 0.05%: reducing chemosis and eyelid swelling in subjects with seasonal allergic conjunctivitis. Emadine Study Group.

Año 2000
Revista Acta ophthalmologica Scandinavica. Supplement
Enlaces DOI , Pubmed

Este artículo está incluido en 1 Revisión sistemática Revisiones sistemáticas (1 referencia)

Cargando información sobre las referencias
Mostrar resumen

PURPOSE:

To compare emedastine ophthalmic solution 0.05% BID to levocabastine ophthalmic suspension 0.05% BID in reducing chemosis, eyelid swelling and other signs and symptoms in subjects with seasonal allergic conjunctivitis.

METHODS:

In a randomized, double-masked, parallel controlled study, emedastine ophthalmic solution 0.05% BID was compared to levocabastine ophthalmic suspension 0.05% BID for control of chemosis, eyelid swelling and other parameters in the environmental allergy study model.

RESULTS:

At Days 7, 14, 30 and 42, emedastine was significantly better than levocabastine at controlling chemosis and eyelid swelling (p < 0.05). A statistical trend was seen at Day 3 (0.05 < p < 0.10). Results were clinically relevant at Days 30 and 42. Emedastine was also significantly better at reducing redness and itching at Days 7, 14, 30 and 42 (p < 0.05).

CONCLUSION:

Emedastine is more efficacious than levocabastine in reducing chemosis, eyelid swelling and other efficacy variables associated with seasonal allergic conjunctivitis.

Mostrar resumen

Estudio primario

No clasificado

Nedocromil sodium 2% eye drops for twice-daily treatment of seasonal allergic conjunctivitis: a Swedish multicentre placebo-controlled study in children allergic to birch pollen

Año 1994
Revista Clinical & Experimental Allergy
Enlaces DOI , Pubmed

Este artículo está incluido en 1 Revisión sistemática Revisiones sistemáticas (1 referencia)

Cargando información sobre las referencias
Mostrar resumen

This was a multicentre, double-blind, randomized group comparative study in which 77 children, aged 6–16 years, received 2% nedocromil sodium eye drops and 72 received placebo, one drop into each eye twice daily. The treatment period was 4 weeks, covering the peak birch pollen season. Prior to the start or the season, patients who had mended the clinic the previous 2 years because of seasonal allergic conjunctivitis (SAC) to birch pollen, entered a one week baseline period during which symptoms were assessed, diary cards completed, and routine sampling of blood and urine earned out. The double-blind treatment period then commenced at the onset of the birch pollen season. Patients parents kept daily diary record cards of eye symptom severity and concomitant therapy. Conjunctivitis was mild in both treatment groups but nedocromil sodium was more effective than placebo in controlling symptoms. During the 2–3 weeks of peak pollen counts, this therapeutic effect was statistically significant for itching (P <0–01), watering (P <0.05) and total symptom score (P <0.01), but was not significant for grittiness (P= 0.08) or redness (P = 0.06). Global opinions of efficacy showed no difference between treatments, due to a high placebo effect (however, the diary card data indicated a significant improvement with nedocromil sodium). We therefore conclude that nedocromil sodium 2% eye drops, administered twice daily, is an effective treatment for SAC in children.

Mostrar resumen

Estudio primario

No clasificado

Double-blind group comparative study of 2% nedocromil sodium eye drops with 2% sodium cromoglycate and placebo eye drops in the treatment of seasonal allergic conjunctivitis

Año 1992
Revista Clinical & Experimental Allergy
Enlaces DOI

Este artículo está incluido en 1 Revisión sistemática Revisiones sistemáticas (1 referencia)

Cargando información sobre las referencias
Mostrar resumen

A 4 week, multicentre, double-blind, double dummy, placebo controlled group comparative study was carried out during the birch pollen season to compare the efficacy and tolerability of 2% nedocromil sodium eye drops (twice daily) and 2% sodium cromoglycate eye drops (four times daily). Participants with a history of seasonal allergic conjunctivitis (SAC) were randomized to receive nedocromil sodium (60), sodium cromoglycate (61) or placebo (64). Clinical assessment of SAC showed improvement with both active treatments compared to placebo but symptomatology was low and only changes in photophobia and grittiness reached significance (P < 0.05). Patient diaries showed significant control of itching by both active treatments, compared to placebo, with no differences between the active preparations. Patients’ opinions indicated a marked placebo effect: 73% of this group reported full or moderate control of symptoms, compared with 75% in sodium cromoglycate and 80% in the nedocromil sodium group. Unusual symptoms were most common (27 patients) with nedocromil sodium eye drops: P < 0.05 vs. placebo (15 patients). There were no serious adverse events. Nedocromil sodium eye drops (b.d.) and sodium cromoglycate eye drops (q.i.d.) were both considered clinically more effective than placebo in controlling symptoms of SAC due to birch pollen.

Mostrar resumen

Estudio primario

No clasificado

3-day treatment with azithromycin 1.5% eye drops versus 7-day treatment with tobramycin 0.3% for purulent bacterial conjunctivitis: multicentre, randomised and controlled trial in adults and children.

Año 2007
Revista The British journal of ophthalmology
Enlaces DOI , Pubmed , PMC

Este artículo está incluido en 1 Revisión sistemática Revisiones sistemáticas (1 referencia)

Cargando información sobre las referencias
Mostrar resumen

AIM:

To compare the efficacy and safety of Azyter, azithromycin 1.5% eye drops, for 3 days with tobramycin 0.3% for 7 days to treat purulent bacterial conjunctivitis.

METHODS:

This was a multicentre, randomised, investigator-masked study including 1043 children and adults with purulent bacterial conjunctivitis. Patients received either azithromycin 1.5% twice-daily for 3 days or tobramycin 0.3%, 1 drop every two hours for 2 days, then four times daily for 5 days. Clinical signs were evaluated and cultures obtained at D0, D3 and D9 (where D refers to "day"). Primary variable was the clinical cure at the Test-of-Cure (TOC)-visit (D9+/-1), for patients with D0-positive cultures. The cure was defined as: bulbar conjunctival injection and discharge scores of 0.

RESULTS:

Among 471 patients with D0-positivity in the per protocol set, 87.8% of the azithromycin 1.5% group and 89.4% of the tobramycin group were clinically cured at the TOC-visit. Azithromycin was non-inferior to tobramycin for clinical and bacteriological cure. Clinical cure was significantly higher with azithromycin 1.5% at D3. The safety profile of azithromycin was satisfactory with a good patient and investigator's acceptability.

CONCLUSIONS:

Azithromycin 1.5% for 3 days was as effective and as safe as tobramycin for 7 days. Furthermore, more azithromycin than tobramycin patients presented an early clinical cure at Day 3. Due to its twice daily dosing regimen for 3 days, azithromycin represents a step forward in the management of purulent bacterial conjunctivitis, especially in children.

Mostrar resumen

Estudio primario

No clasificado

Comparison of the effects of ketotifen fumarate 0.025% and olopatadine HCl 0.1% ophthalmic solutions in seasonal allergic conjunctivities: a 30-day, randomized, double-masked, artificial tear substitute-controlled trial.

Año 2005
Autores Avunduk AM , Tekelioglu Y , Turk A , Akyol N
Revista Clinical therapeutics
Enlaces DOI , Pubmed

Este artículo está incluido en 2 Revisiones sistemáticas Revisiones sistemáticas (2 referencias)

Cargando información sobre las referencias
Mostrar resumen

BACKGROUND:

Topical antiallergic agents, such as antihistamines and mast-cell stabilizers, are the main therapeutic options for seasonal allergic conjunctivitis (SAC). Ketotifen fumarate and olopatadine HCl have dual action that offers a combination of these 2 mechanisms. Although clinical studies comparing the efficacy of these 2 drugs have shown that both were effective in the treatment of SAC, the results were contradictory and did not include the effects of these drugs on inflammatory markers.

OBJECTIVES:

The aims of this study were to compare the clinical efficacy of topical ketotifen and olopatadine eye drops and to determine the effects of these 2 drugs on the expression of cell adhesion molecules (CAMs) and inflammatory markers in conjunctival surface cells in patients with SAC.

METHODS:

This 30-day, randomized, double-masked, artificial tear substitute (ATS)-controlled clinical trial was conducted at the Department of Ophthalmology, Karadeniz Technical University, School of Medicine, Trabzon, Turkey. Patients with SAC were included in the study and randomly assigned to 1 of 3 groups: topical ketotifen fumarate 0.025% ophthalmic solution, topical olopatadine HCl 0.1% ophthalmic solution, or ATS (control group). All drugs were administered 2 drops per eye BID for 30 days. At the beginning of the study (day 0; baseline), on day 15, and on day 30, clinical scores (itching, tearing, redness, eyelid, swelling, and chemosis) and conjunctival impression cytology specimens were obtained. The percentages of cells expressing intercellular adhesion molecule 1, vascular CAM-1, human leukocyte antigen-DR, and beta1-integrin (CD29) from conjunctival impression cytology specimens were determined using flow cytometry. Patients were questioned about adverse events (AEs) at each visit. Ocular discomfort on installation of the drugs was recorded as an AE.

RESULTS:

Thirty-nine patients (20 men, 19 women; age range, 18-61 years) with SAC were included. Twelve patients received ketotifen; 13, olopatadine; and 14, ATS. In both active-treatment groups, the improvements of clinical scores (tearing and itching) were more pronounced compared with those in the ATS group, although the day-30 difference in tearing score between the olopatadine and ATS groups was not statistically significant. No significant within-group or between-group differences in mean scores for redness, chemosis, or eyelid swelling were found. The expression rates of CAMs and inflammatory markers in conjunctival surface cells were significantly more reduced with ketotifen and olopatadine compared with ATS. However, clinical and flow cytometric parameters were improved with ATS at 15 and 30 days compared with baseline. No AEs were observed during the study period.

CONCLUSIONS:

In this short-term study in a selected, small study population with SAC, ketotifen and olopatadine diminished the expression of CAMs and inflammatory markers on the conjunctival surface cells effectively. Both active treatments were more efficacious compared with ATS and were well tolerated.

Mostrar resumen

Estudio primario

No clasificado

Trimethoprim-polymyxin B sulphate ophthalmic ointment versus chloramphenicol ophthalmic ointment in the treatment of bacterial conjunctivitis--a review of four clinical studies. The Trimethoprim-Polymyxin B Sulphate Ophthalmic Ointment Study Group.

Año 1989
Autores [No se listan los autores]
Revista The Journal of antimicrobial chemotherapy
Enlaces DOI , Pubmed

Este artículo está incluido en 1 Revisión sistemática Revisiones sistemáticas (1 referencia)

Cargando información sobre las referencias
Mostrar resumen

Five hundred and twenty-eight patients with a clinical diagnosis of bacterial conjunctivitis were enrolled in four randomized, double-blind, parallel studies. Patients were treated with trimethoprim-polymyxin B sulphate (TP) or chloramphenicol ophthalmic ointments, four times a day for seven days in three studies, and three times a day for five days in one. Data suitable for evaluation of efficacy and safety were obtained from 448 patients. The results of each study were analysed separately and indicated that both treatments were effective and well tolerated and that there were no statistically significant differences between them. However, in three studies, efficacy trends generally favoured TP ophthalmic ointment and in one study efficacy trends favoured chloramphenicol ophthalmic ointment. A wide range of pathogenic or potentially pathogenic organisms was isolated, with Haemophilus influenzae being the most prevalent.

Mostrar resumen

Estudio primario

No clasificado

Efficacy and tolerability of besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days in the treatment of bacterial conjunctivitis: a multicenter, randomized, double-masked, vehicle-controlled, parallel-group study in adults and children.

Año 2011
Revista Clinical therapeutics
Enlaces DOI , Pubmed

Este artículo está incluido en 2 Revisiones sistemáticas Revisiones sistemáticas (2 referencias)

Cargando información sobre las referencias
Mostrar resumen

BACKGROUND:

Besifloxacin is a topical fluoroquinolone with potent in vitro activity against a broad spectrum of ocular pathogens, including drug-resistant strains. Besifloxacin ophthalmic suspension 0.6% given 3 times daily for 5 days has been reported to be more effective than its vehicle in the treatment of bacterial conjunctivitis. Pharmacokinetic/pharmacodynamic modeling suggests that besifloxacin might also be effective given twice daily.

OBJECTIVE:

This study evaluated the efficacy and tolerability of besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days compared with vehicle (formulation without besifloxacin) in the treatment of adults and children with bacterial conjunctivitis.

METHODS:

This was a multicenter, prospective, randomized, double-masked, vehicle-controlled, parallel-group study. Patients aged ≥1 year with bacterial conjunctivitis were randomized to receive besifloxacin ophthalmic suspension or vehicle administered twice daily for 3 days. There were 3 study visits: the baseline visit, visit 2 (day 4 or 5), and visit 3 (day 7±1). Participants recorded the times of medication instillation in a patient diary. The primary end points were clinical resolution and bacterial eradication of the baseline bacterial infection at visit 2 in patients with culture-confirmed bacterial conjunctivitis. Secondary end points were clinical resolution and bacterial eradication of the baseline bacterial infection at visit 3, individual clinical outcomes (ocular conjunctival discharge and bulbar conjunctival injection) at the follow-up visits, and microbial and clinical outcomes for overall bacterial species and individual gram-positive and gram-negative bacterial species. Tolerability assessments included ocular adverse events (AEs), changes in visual acuity, biomicroscopy and ophthalmoscopy findings, and nonocular AEs.

RESULTS:

Of 202 patients randomized to treatment (mean [SD] age, 25.2 [24.3] years; 56.9% female; 76.7% white), 109 had culture-confirmed bacterial conjunctivitis (53 besifloxacin ophthalmic suspension, 56 vehicle). At visit 2, the besifloxacin ophthalmic suspension group had significantly greater rates of clinical resolution compared with the vehicle group (37/53 [69.8%] vs 21/56 [37.5%], respectively; P < 0.001), as well as significantly greater rates of bacterial eradication (46/53 [86.8%] vs 32/56 [57.1%]; P < 0.001). At visit 3, rates of bacterial eradication were also significantly greater in the besifloxacin ophthalmic suspension group compared with the vehicle group (46/53 [86.8%] vs 39/56 [69.6%]; P = 0.038). Results for the individual clinical outcomes and microbial and clinical outcomes by gram-positive and gram-negative species were consistent with the primary efficacy outcomes. The incidence of ocular AEs did not differ significantly between treatment groups (4/94 [4.3%] vs 8/98 [8.2%]). Ocular AEs in all treated eyes in the respective groups included bacterial conjunctivitis (3/157 [1.9%] and 5/154 [3.2%]), conjunctivitis (3/157 [1.9%] and 4/154 [2.6%]), and allergic conjunctivitis (2/157 [1.3%] and 1/154 [0.6%]). These events were of mild or moderate severity. Changes in visual acuity and biomicroscopy and ophthalmoscopy findings were comparable between groups. There were few nonocular AEs (2/94 [2.1%] vs 3/98 [3.1%]; P = NS), none of them considered treatment related.

CONCLUSION:

In these adults and children with bacterial conjunctivitis, treatment with besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days was effective and well tolerated. ClinicalTrials.gov identifier: NCT00972777.

Mostrar resumen

Estudio primario

No clasificado

Clinical and virologic assesment of two therapeutic options: antiviral Ganciclovir 0.15% ophthalmic gel and physiologic saline solution 0.9% used in patients with acute adenoviral conjuntivitis.

Año 2014
Autores Ana Boto de los Bueis
Registro de estudios EU Clinical Trials Register
Enlaces EUCTR

Este artículo no está incluido en ninguna revisión sistemática

Cargando información sobre las referencias
Mostrar resumen

INTERVENTION:

Trade Name: VIRGAN Gel oftálmico 1,5 mg/g Product Name: VIRGAN Gel oftálmico 1,5 mg/g Pharmaceutical Form: Eye gel INN or Proposed

INN:

2‐amino‐9‐{[(1,3‐dihydroxypropan‐2‐yl)oxy]methyl}‐6,9‐dihydro‐3H‐purin‐6‐one CAS Number: 82410‐32‐0 Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 1.5‐ Trade Name: Hidrathea Product Name: Hidrathea Pharmaceutical Form: Eye drops INN or Proposed

INN:

Sodium chloride CAS Number: 7647‐14‐5 Other descriptive name: Salt Concentration unit: mg/ml milligram(s)/millilitre Concentration type: not less then Concentration number: 9‐

CONDITION:

Acute adenoviral conjunctivitis ; MedDRA version: 18.0 Level: PT Classification code 10001257 Term: Adenoviral conjunctivitis System Organ Class: 10021881 ‐ Infections and infestations Therapeutic area: Diseases [C] ‐ Eye Diseases [C11]

PRIMARY OUTCOME:

Main Objective: To evaluate the viral and clinical response reached by an antiviral drug (ganciclovir 0.15%) and an ocular hydrating agent (0.9%) in patients with acute adenoviral conjunctivitis. Primary end point(s): 1. Analysis of viral load from conjunctival samples of the patients.; 2. Analysis of the symptomatology described by the patient in agreement with listed symptoms specified in the protocol (foreing body sensation, photophobia, tearing, burning/itching).; 3. Analysis of clinical signs showed during ophthalmic examination (edema, injection, secretion, corneal staining, pseudomembranes). Secondary Objective: ‐To know the incidence of acute adenoviral conjunctivitis in the investigational site; ‐To identify the most frequent adenovitral strains foun in the investigational site; ‐To evaluate the most suggesting symptoms associated to adenoviral conjunctivitis; ‐To evaluate the safety of the two treatments used during the trial Timepoint(s) of evaluation of this end point: 1 D0 (basal value) and D2, D4 and D7; 2. D0 (basal value) and D4, D7, D21 and D90; 3. D0 (basal value) and D2, D4, and D7 (edema, injection, secretion, corneal staining, pseudomembranes).; D0 (basal value) and D21 and D90 (edema and pseudomembranes)

SECONDARY OUTCOME:

Secondary end point(s): ‐Analysis of visual acuity score by best corrected visual acuity parameter (BCVA); ‐Analysis and identification of local/systemic, simple/serious adverse reactions. Timepoint(s) of evaluation of this end point: ‐D0 (basal value) and D21, D90.; ‐During the whole study time.

INCLUSION CRITERIA:

1. Male or female aged ? 18 years old 2. Patients with uni or bilateral folicular conjunctivitis (7 days) and at least one of the following signs: ‐Tarsal micro‐haemorrhages ‐Preauricular lynphadenopathy ‐Previous or ongoing upper respiratory disease ‐Known history of recent contact with viral conjunctivitis ‐Iatrogenic exposure to viral infection (ophtlamologist, health‐care center) during last 7 days 3. Patients understanding complexity of the study and agree with signed informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 28 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8

Mostrar resumen

Estudio primario

No clasificado

"Eficacia y seguridad en el tratamiento de conjuntivitis por adenovirus tratados con olopatadina (Opatanol®) y lágrimas artificiales (Acuolens®)) vs pranoprofeno (Oftalar®) y lágrimas artificiales (Acuolens®)"

Año 2007
Registro de estudios EU Clinical Trials Register
Enlaces EUCTR

Este artículo no está incluido en ninguna revisión sistemática

Cargando información sobre las referencias
Mostrar resumen

INTERVENTION:

Trade Name: Opatanol Product Name: Opatanol Product Code: Olopatadina Pharmaceutical Form: Eye drops, solution INN or Proposed

INN:

Olopatadina Current Sponsor code: Olopatadina Other descriptive name: Olopatadina Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1‐ Trade Name: Oftalar Product Name: Oftalar Product Code: Pranoprofeno Pharmaceutical Form: Eye drops, solution INN or Proposed

INN:

Pranoprofen Current Sponsor code: Pranoprofen Other descriptive name: Pranoprofen Concentration unit: mg/l milligram(s)/litre Concentration type: equal Concentration number: 1‐

CONDITION:

Conjuntivitis vírica por Adenovirus Adenoviral conjuntivitis

PRIMARY OUTCOME:

Main Objective: El objetivo principal del estudio es determinar la eficacia y la seguridad del tratamiento con olopatadina vs pranoprofeno para tratar la conjuntivitis por Adenovirus.; ; The main objective of the study is to assess the efficacy and the security with olopatadine vs pranoprofen in adenoviral conjunctivitis treatment. Primary end point(s): De eficacia: inyección conjuntival, quemosis conjuntival, queratitis punctacta superficial, infiltrados corneales subepiteliales, presencia/ausencia de pseudomembranas, agudeza visual corregida, test de Schirmer, fotofobia, escozor, sensación de cuerpo extraño; ; De seguridad: eventos adversos Secondary Objective: El objetivo secundario del estudio es identificar los factores clínico‐epidemiológicos asociados con las variables de eficacia y de seguridad.; ; The secondary objective is identified the clinical‐epidemiological factors associated with the efficacy and security variables.

INCLUSION CRITERIA:

‐Pacientes adultos mayores de 18 años ‐Sospecha clínica de compatibilidad aguda por Adenovirus incluyendo todos los siguientes síntomas, inyección conjuntival, quemosis, edema palpebral y epífora. ‐Menos de 6 días de inicio de la patología ‐El paciente debe satisfacer todos los requerimientos del Consentimiento Informado ‐Adult patients (>18) ‐Clinical suspicion of adenoviral infection with the following symptoms, conjunctiva injections, chemosis, palpebral edema and epiphora. ‐Less than 6 days of onset of the pathology ‐Patient satisfaction Informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Mostrar resumen