| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00586664 | Efficacy and Safety Study of Bepotastine Besilate Ophthalmic Solution in Allergic Conjunctivitis | PHASE3 | COMPLETED | 130 | — | — | Oct 1, 2007 | Jun 1, 2008 | Feb 8, 2013 | 1 | United States |
| NCT01174823 | Safety and Efficacy of Bepotastine Besilate Ophthalmic Solution in Seasonal Allergic Conjunctivitis Patients | PHASE2 | COMPLETED | 245 | — | — | Jun 1, 2010 | Dec 1, 2010 | Sep 14, 2020 | 1 | United States |
Ocular Itching score: 0=None; 0.5=Intermittent tickle sensation possibly localized in the corner of the eye; 1.0=Intermittent tickle sensation involving more than the corner of the eye; 1.5=Intermittent all-over tickling sensation; 2.0=Mild continuous itch (can be localized) without desire to rub; 2.5=Moderate, diffuse continuous itch with desire to rub; 3.0=Severe itch with desire to rub; 3.5=Severe itch improved with minimal rubbing; 4.0=Incapacitating itch with irresistible urge to rub
Conjunctival Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade
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.
| Arm | Type | Description |
|---|---|---|
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | EXPERIMENTAL | - |
| Bepotastine Besilate Ophthalmic Solution 1.0% | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Bepotastine Besilate Ophthalmic Solution | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Bepreve (bepotastine besilate ophthalmic solution) 1.5% | DRUG | sterile ophthalmic solution |
| placebo comparator | DRUG | sterile ophthalmic solution |
| Bepotastine Besilate Ophthalmic Solution 1.0% | DRUG | sterile ophthalmic solution |
| bepotastine besilate ophthalmic solution | DRUG | sterile ophthalmic solution |
| placebo comparator ophthalmic solution | DRUG | sterile ophthalmic solution |
Inclusion Criteria: * Subjects must be at least 10 years of age Exclusion Criteria: * No active ocular disease