Safety and Efficacy of Bepotastine Besilate Ophthalmic Solution in Seasonal Allergic Conjunctivitis Patients

Study Overview
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Brief Summary
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The purpose of this study is to study the safety and efficacy of bepotastine besilate ophthalmic solution in allergic conjunctivitis patients.

Conditions
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Allergic Conjunctivitis

Intervention / Treatment
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* Drug: bepotastine besilate ophthalmic solution
* Drug: placebo comparator ophthalmic solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects 12 years of age and older with 2-year history of allergic conjunctivitis Exclusion Criteria: No active ocular or nasal infection

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bepotastine Besilate Ophthalmic Solution<br> | Drug: bepotastine besilate ophthalmic solution<br>* sterile ophthalmic solution<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo comparator ophthalmic solution<br>* sterile ophthalmic solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Mean Change in Total Score | Responses to questions relating to symptoms and daily activities in the RQLQ were provided for 28 questions encompassing the 7 major domains of activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional state. Each response to an RQLQ question was provided on a scale of 0-6 units, where 0 = not troubled/none of the time and 6 = extremely troubled/all of the time. The minimum total score was 0 units and the maximum total score was 42 units, with higher score indicating decreased quality of life due to rhinoconjunctivitis. | Baseline, 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline for Twice Daily (BID) Averaged Reflective Ocular Itching Scores Over the Treatment Period | Ocular itching was graded on a 4-point scale (0-3 units; 0=Absent, 1=Mild, 2=Moderate, 3=Severe) twice daily in the Screening Diary (Day -7 to Day -1) and the Subject Diary (Day 0 prior to first dose through Day 13). | Baseline, 14 days | 
| Mean Change From Baseline for Twice Daily (BID) Averaged Instantaneous Ocular Redness Scores Over the Treatment Period | Ocular redness each was graded on a 4-point scale (0-3 units; 0=Absent, 1=Mild, 2=Moderate, 3=Severe) twice daily in the Screening Diary (Day -7 to Day -1) and the Subject Diary (Day 0 prior to first dose through Day 13). | Baseline, 14 days | 
| Mean Change From Baseline for Twice Daily (BID) Averaged Proportion of Tearing Episodes Over the Treatment Period | Individual nasal symptoms and ocular itching and redness each were graded on a 4-point scale (0-3 units; 0=Absent, 1=Mild, 2=Moderate, 3=Severe) BID in the Screening Diary (Day -7 to Day -1) and BID in the Subject Diary (Day 0 prior to first dose through Day 13). Tearing was scored from Day 0 as either absent or present at the same time as nasal and other ocular symptoms were graded. The proportion of participants was calculated and then then average of the proportions. | Baseline, 14 days | 
| Mean Change From Baseline for Twice Daily (BID) Averaged Reflective Total Nasal Symptom Scores Over the Treatment Period | Individual nasal symptoms of rhinorrhea, nasal congestion, nasal itching, and sneezing each were each graded on a 4-point scale (0-3 units; 0=Absent, 1=Mild, 2=Moderate, 3=Severe) twice daily in the Screening Diary (Day -7 to Day -1) and the Subject Diary (Day 0 prior to first dose through Day 13). The minimum Total Nasal Symptom Score (TNSS) was 0 units and the maximum TNSS corresponding to multiple individual nasal symptoms scored as severe was 12 units | Baseline, 14 days | 
| Global Therapeutic Response Rating - Participant Assessed | Participants were asked if they felt that they had experienced improvement in allergy symptoms after therapy. Participant assessed global therapeutic response rating: categories that the participant could select were 'no change', 'slight improvement', 'improved', or 'marked improvement'. | 14 days | 
| Global Therapeutic Response Rating - Investigator Assessed | Investigators were asked if they felt that the participant had experienced improvement in allergy symptoms after therapy. Investigator assessed global therapeutic response rating: categories that the investigator could select were 'no change', 'slight improvement', 'improved', or 'marked improvement'. | 14 days |