Phase 2
Completed N=245
Safety and Efficacy of Bepotastine Besilate Ophthalmic Solution in Seasonal Allergic Conjunctivitis Patients
Source: ClinicalTrials.gov NCT01174823 ↗Enrolled (actual)
245
Serious AEs
0.4%
Results posted
Sep 2020
Primary outcomePrimary: Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Mean Change in Total Score — -1.18; -1.17 score on a scale
Summary
The purpose of this study is to study the safety and efficacy of bepotastine besilate ophthalmic solution in allergic conjunctivitis patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Mean Change in Total Score |
-1.18; -1.17 | — |
| SECONDARY Mean Change From Baseline for Twice Daily (BID) Averaged Reflective Ocular Itching Scores Over the Treatment Period |
-0.54; -0.71 | — |
| SECONDARY Mean Change From Baseline for Twice Daily (BID) Averaged Instantaneous Ocular Redness Scores Over the Treatment Period |
-0.45; -0.62 | — |
| SECONDARY Mean Change From Baseline for Twice Daily (BID) Averaged Proportion of Tearing Episodes Over the Treatment Period |
-0.15; -0.18 | — |
| SECONDARY Mean Change From Baseline for Twice Daily (BID) Averaged Reflective Total Nasal Symptom Scores Over the Treatment Period |
-1.73; -2.08 | — |
| SECONDARY Global Therapeutic Response Rating - Participant Assessed |
24; 27; 64; 72 | — |
| SECONDARY Global Therapeutic Response Rating - Investigator Assessed |
16; 29; 56; 70 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects 12 years of age and older with 2-year history of allergic conjunctivitis
Exclusion Criteria
- No active ocular or nasal infection
Data sourced from ClinicalTrials.gov (NCT01174823). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.