Estudio primario

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Año 2005
Revista Lancet
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BACKGROUND:

One in eight schoolchildren have an episode of acute infective conjunctivitis every year. Standard clinical practice is to prescribe a topical antibiotic, although the evidence to support this practice is scarce. We undertook a randomised double-blind trial to compare the effectiveness of chloramphenicol eye drops with placebo in children with infective conjunctivitis in primary care.

METHODS:

Our study included 326 children aged 6 months to 12 years with a clinical diagnosis of conjunctivitis who were recruited from 12 general medical practices in the UK. We assigned 163 children to receive chloramphenicol eye drops and 163 to receive placebo eye drops. Eye swabs were taken for bacterial and viral analysis. The primary outcome was clinical cure at day 7, which was assessed from diaries completed by parents. All children were followed up for 6 weeks to identify relapse. Survival statistics were used for comparison, and analysis was by intention to treat.

FINDINGS:

Nine children were lost to follow-up (one in chloramphenicol group; eight in placebo group). Clinical cure by day 7 occurred in 128 (83%) of 155 children with placebo compared with 140 (86%) of 162 with chloramphenicol (risk difference 3.8%, 95% CI -4.1% to 11.8%). Seven (4%) children with chloramphenicol and five (3%) with placebo had further conjunctivitis episodes within 6 weeks (1.2%, -2.9% to 5.3%). Adverse events were rare and evenly distributed between each group.

INTERPRETATION:

Most children presenting with acute infective conjunctivitis in primary care will get better by themselves and do not need treatment with an antibiotic.

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Estudio primario

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Año 2003
Autores Chisari G , Sanfilippo M , Reibaldi M
Revista Le infezioni in medicina

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The authors studied the epidemiology of external ocular infections and the therapeutic efficacy of topical ciprofloxacin and norfloxacin in the treatment of conjunctivitis and blepharitis. Signs and symptoms in two study-group (ciprofloxacin group A = 95 patients and norfloxacin group B = 95 patients) as well as the microbiological data obtained from the conjunctival swab before and after treatment were considered. The clinical and bacteriological success rate in the two study-groups was respectively 91% (group A) and 83% (group B). The results of the present study confirm the therapeutic efficacy of topical fluoroquinolones in the treatment of bacterial conjunctivitis and blepharitis.

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Estudio primario

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Año 2001
Revista Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology
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BACKGROUND:

Olopatadine ophthalmic solution 0.1% (Patanol, Alcon Laboratories, Fort Woth, TX) is approved for the treatment of the signs and symptoms of allergic conjunctivitis. Loratadine 10 mg (Claritin, Schering-Plough, Madison, NJ) is a nonsedating oral antihistamine approved for the treatment of the signs and symptoms of allergic rhinitis.

OBJECTIVE:

To compare the efficacy of olopatadine used adjunctively with loratadine versus loratadine alone in patients with seasonal allergic conjunctivitis.

METHODS:

This three-center, observer-masked, treatment-controlled, randomized, parallel-group study involved patients aged 7 to 74 years with seasonal allergic conjunctivitis. Patients were treated for 7 days with either olopatadine twice daily adjunctive to loratadine once daily or only loratadine once daily. Efficacy variables (ocular itching and redness, physician's impression, patient's impression, patient diary ratings of ocular redness and itching), and safety parameters were evaluated during the screening visit and on days 0, 3, and 7. Patients completed the rhinoconjunctivitis quality of life questionnaire on days 0 and 7.

RESULTS:

Ninety-four patients received study drug. Patients receiving olopatadine twice daily in addition to loratadine once daily exhibited less ocular itching (P = 0.0436) and rated their ocular condition as more improved compared with those receiving loratadine alone (P < 0.0022). Twenty minutes after initial dosing, olopatadine plus loratadine relieved ocular itching and redness significantly better than loratadine alone (P = 0.001). Both treatment groups showed clinically meaningful improvements in overall quality of life in all but one of the rhinoconjunctivitis quality of life questionnaire domains. Overall, and in most domains, olopatadine plus loratadine also provided significantly better (P < 0.05) quality of life than loratadine alone at day 7.

CONCLUSIONS:

Compared with loratadine alone, olopatadine adjunctive to loratadine provides greater relief of ocular itching and redness, a better quality of life, and is well tolerated in patients with seasonal allergic conjunctivitis.

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Año 1997
Revista Current medical research and opinion
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This double-blind, randomised, placebo-controlled study was carried out to assess the efficacy and safety of 0.025% and 0.05% azelastine eye drops twice daily administered for 14 days to patients with seasonal allergic conjunctivitis or rhinoconjunctivitis. A total of 278 patients were recruited and 226 patients were evaluable for per protocol analysis. The target parameter was the response rate. Four eye symptoms, including the main symptom (itching) were recorded by patients in diaries and eight symptoms were assessed by physicians before and after seven and 14 days of treatment. Severity of symptoms was measured on a four-point scale. The response rates for itching (improvement of at least one score point within the first three days) according to patient assessment were 43% for placebo, 52% for 0.025% and 56% for 0.05% azelastine (NS). However, a more objective assessment of the three main eye symptoms by physicians showed a concentration-dependent improvement in response rate compared with placebo (a decrease of > or = 3 points from a baseline total score of > or = 6), which reached statistical significance for 0.05% azelastine on Day 7 (p < 0.002). In the evaluable patient population, the scores of the three main eye symptoms as well as of all eight recorded eye symptoms, as assessed by the physician, were significantly (p < 0.05) lower in the 0.05% azelastine eye drops group in comparison with the placebo group at Day 7. Inefficacy was the cause of withdrawal in five and three patients on 0.025% and 0.05% azelastine, respectively, and in six patients on placebo. Adverse drug effects, mainly a mild, transient irritation and a bitter or unpleasant taste, were reported by 14% (0.025%), 20% (0.05%) and 15% (placebo) of the patients. No serious side-effects occurred. Azelastine eye drops are effective and well tolerated at a concentration of 0.05% for the treatment of seasonal allergic conjunctivitis.

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Año 1988
Revista Journal of medical virology
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Enterovirus 70 (EV-70) has caused at least two pandemics and several major epidemics of acute hemorrhagic conjunctivitis (AHC) in the past 18 years, with the largest number of cases occurring in the coastal areas of the tropics. The exact means of its spread are not known, but fomites and hands contaminated by them are the most likely vehicles. We, therefore, tested EV-70 survival under different environmental conditions using stainless steel disks (1 cm diameter). Each disk received 10 microliter of the virus in phosphate-buffered saline (PBS). The disks were held at various temperatures with the relative humidity (RH) at the low (20 +/- 5%), medium (50 +/- 5%), high (80 +/- 5%), or ultrahigh (95 +/- 5%) level. The virus was eluted from the disks with tryptose phosphate broth and the eluate assayed in LLC-MK2cells. Inactivation rates (Ki), expressed as hourly loss of virus plaque forming units (PFU) in log10, were then calculated. At 20 degrees C, virus survival was proportional to the RH level, with the highest virus survival at the ultrahigh RH; at this level nearly 5% of the input virus was detectable even after 24 hr. Virus inactivation rates were only slightly higher at the ultrahigh RH when the temperature was raised to 33 degrees C or 35 degrees C. However, at 80% RH, increasing the temperature from 20 degrees C to 33 degrees C resulted in a dramatic rise in virus inactivation. The finding that high levels of RH prolong EV-70 survival on fomites may help explain the epidemiology of AHC resulting from EV-70.

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Estudio primario

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Año 1991
Revista Annales de pédiatrie
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This study carried out at the Saint-Germain-en-Laye Hospital maternity ward included all the neonates delivered between February and September 1989 who exhibited no abnormal manifestations during their stay in the ward, except for ocular symptoms in some subjects. Nine hundred neonates were enrolled. Each day, one of two eyedrop preparations for the prevention of neonatal ocular infections was selected at random. Investigators were blinded to the preparation used. Study subjects were evaluated twice, between D1 and D7 (900 infants) and between D15 and D30 (407 infants). Ocular findings were classified as follows: normal, minimally abnormal (isolated swelling of the eyelids, clear discharge), or frankly abnormal (conjunctivitis, purulent discharge). A bacteriologic study was performed in all patients with minimally abnormal or abnormal findings. Between D1 and D7, ocular symptoms were significantly (p less than 0.05) more prevalent in neonates treated with silver nitrate than in neonates treated with oxytetracycline hydrochloride. This difference was no longer present between D15 and D30. Bacteriologic studies recovered no gonococci. One enfant in the oxytetracycline group had bacteriologically confirmed Chlamydia trachomatis ocular infection. The other organisms recovered were mainly Staphylococcus aureus and non-hemolytic streptococci. In inclusion, no currently available eyedrop preparation offers complete protection against C. trachomatis but tolerance is considerably better with oxytetracycline hydrochlorate than with silver nitrate.

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Año 2014
Revista Infection control and hospital epidemiology

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Hospital employees with suspected adenoviral conjunctivitis underwent evaluation and testing with real-time polymerase chain reaction. Viral conjunctivitis was suspected in 307 (59%) of 518 employees with eye complaints; adenovirus was detected in 4% (22 of 518). Four employees had genotypes consistent with epidemic keratoconjunctivitis. This algorithm minimizes productivity loss compared with clinical diagnosis.

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Año 2012
Revista Clinical drug investigation
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BACKGROUND AND OBJECTIVE:

Besifloxacin ophthalmic suspension 0.6% given thrice daily for 5 days is safe and effective in the treatment of patients with bacterial conjunctivitis. This study evaluated the safety and efficacy of besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days compared with vehicle in the treatment of bacterial conjunctivitis.

STUDY DESIGN:

This was a multicenter, double-masked, randomized, vehicle-controlled, parallel-group study.

METHODS:

A total of 474 patients aged ≥1 year with bacterial conjunctivitis were randomized in a 1 : 1 ratio to receive either besifloxacin ophthalmic suspension 0.6% or vehicle administered twice daily for 3 days. There were three study visits: day 1 (the baseline visit), day 4/5 (visit 2), and day 7 ± 1 (visit 3). The co-primary efficacy endpoints were bacterial eradication and clinical resolution at day 4/5 in designated study eyes of patients with culture-confirmed bacterial conjunctivitis. Secondary efficacy endpoints were bacterial eradication and clinical resolution at day 7 ± 1, individual clinical outcomes of ocular discharge and bulbar conjunctival injection at all visits; and microbial and clinical outcomes for overall bacterial species and individual Gram-positive and Gram-negative bacterial species at each follow-up visit. Safety endpoints included adverse events (AEs), changes in visual acuity and biomicroscopy findings at each visit, and changes in ophthalmoscopy findings at day 7 ± 1.

RESULTS:

Bacterial eradication and clinical resolution rates were significantly higher in the besifloxacin group than in the vehicle group (115/135 [85.2%] vs 77/141 [54.6%], p < 0.001, and 89/135 [65.9%] vs 62/141 [44.0%], p < 0.001, respectively) at day 4/5. Rates of bacterial eradication continued to be significantly greater in the besifloxacin group (115/135 [85.2%] vs 91/141 [64.5%], respectively; p < 0.001) at day 7 ± 1; however, the rates of clinical resolution did not differ significantly between the groups (103/135 [76.3%] and 94/141 [66.7%], p = 0.209) at this visit. Ocular discharge and bulbar conjunctival injection at each visit were consistent with the primary outcomes. Clinical resolution and bacterial eradication with Gram-positive or Gram-negative organisms were consistent with the overall findings. All AEs in both groups were of mild or moderate severity and were considered unrelated to the treatment.

CONCLUSION:

Treatment with besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days was effective and safe in adults and children with bacterial conjunctivitis. Clinical Trial Registration: Registered at ClinicalTrials.gov as NCT00972777.

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Estudio primario

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Año 2003
Revista Current medical research and opinion
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OBJECTIVE AND SETTING:

Azelastine (AZE) in a novel, eye drop, formulation, was compared with topically applied sodium cromoglycate (SCG) and placebo (PLA) in the treatment of seasonal allergic conjunctivitis or rhino-conjunctivitis in a multicentre, parallel group study.

RESEARCH DESIGN:

144 subjects ranging in age from 16 to 65 years participated. All had at least a 2-year history of seasonal allergic conjunctivitis and were symptomatic at the time of inclusion. Medications were administered topically either twice daily (AZE/PLA) or four times daily (SCG) over a 2-week treatment period. Method and outcome measures: Azelastine and placebo were compared double-blind; the comparison versus SCG was carried out in an open manner. Itching, redness, flow of tears, eyelid swelling, foreign-body sensation, photophobia, soreness and discharge were scored on a 4-point severity scale.

RESULTS:

Results for the decrease of main conjunctivitis symptoms (itching, tearing and conjunctival redness) showed a marked effect for both active treatments on day 3 with a sustained improvement on days 7 and 14. A clear response to treatment (an improvement of sum scores for day 3 of >/=3 points compared to baseline) occurred in 85.4% of azelastine-treated patients, 83.0% of sodium cromoglycate patients and 56.3% of placebo patients. Response rates for both active treatments were statistically superior to those for placebo (azelastine p = 0.005; sodium cromoglycate p = 0.007). Global assessment of efficacy was at least 'satisfactory' for 90.0% of azelastine patients, 81.3% of sodium cromoglycate patients and 66.3% of placebo-treated patients. The most frequent adverse effects were transient application site reactions which tended to disappear with increasing duration of treatment, and, less frequently, taste perversion.

CONCLUSION:

The results of this study indicate that the therapeutic use of azelastine eye drops in patients with seasonal allergic conjunctivitis or rhino-conjunctivitis can be recommended.

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Estudio primario

No clasificado

Año 2008
Autores Granet DB , Dorfman M , Stroman D , Cockrum P
Revista Journal of pediatric ophthalmology and strabismus
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Purpose: To compare the speed of clinical efficacy for two currently available topical antibiotics: polymyxin B sulfate/trimethoprim (polymyxin/trimethoprim) and 0.5% moxifloxacin ophthalmic solution. Methods: Eighty-four eyes of 56 patients younger than 18 years with a clinical diagnosis of bacterial conjunctivitis were enrolled in this multi-center study. Patients were randomly assigned to receive either 1 drop of polymyxin/trimethoprim four times daily for 7 days or 1 drop of 0.5% moxifloxacin three times daily for 7 days. Ocular signs and symptoms were evaluated at baseline and 24 and 48 hours after the start of dosing. Microbiological cultures were collected at baseline and 48 hours. Patients rated ocular symptoms and adverse events on day 7 via telephone interview. Primary efficacy assessment included relief of all signs and symptoms of bacterial conjunctivitis. Results: All patients but one completed all visits. At the 48-hour visit, complete resolution of ocular signs and symptoms was observed in 81% of the patients treated with moxifloxacin and 44% of the patients treated with polymyxin/trimethoprim (P = .001). No adverse events were reported. Conclusion: Moxifloxacin 0.5% administered three times daily is safe and cures bacterial conjunctivitis more effectively and significantly faster than polymyxin/trimethoprim dosed four times daily. The majority of patients were cured and symptom-free by 48 hours. Therefore, moxifloxacin is cost-effective and significantly more efficacious than polymyxin/trimethoprim in the speed by which it reduces the symptoms and disease transmission.

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