Phase 3
N=130
Efficacy and Safety Study of Bepotastine Besilate Ophthalmic Solution in Allergic Conjunctivitis
Allergic Conjunctivitis
Bottom Line
View on ClinicalTrials.gov: NCT00586664 ↗Enrolled (actual)
130
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcome: Primary: Ocular Itching — 0.4; 1.9; 0.4; 0.5 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Bepreve (bepotastine besilate ophthalmic solution) 1.5% (Drug); placebo comparator (Drug); Bepotastine Besilate Ophthalmic Solution 1.0% (Drug)
- Age
- Pediatric, Adult, Older Adult · 10+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Itching |
0.4; 1.9; 0.4; 0.5; 2.1; 0.6 | — |
| PRIMARY Conjunctival Redness |
1.4; 1.9; 1.3; 1.6; 2.0; 1.5 | — |
| SECONDARY Ciliary Redness |
1.4; 1.9; 1.2; 1.7; 2.1; 1.5 | — |
| SECONDARY Episcleral Redness |
1.5; 2.0; 1.3; 1.7; 2.1; 1.6 | — |
| SECONDARY Chemosis |
0.3; 0.5; 0.3; 0.4; 0.7; 0.3 | — |
| SECONDARY Eyelid Swelling |
0.2; 0.5; 0.2; 0.3; 0.5; 0.2 | — |
| SECONDARY Rhinorrhea (Runny Nose) |
0.2; 0.9; 0.3; 0.3; 1.1; 0.3 | — |
| SECONDARY Nasal Pruritus (Itchy Nose) |
0.1; 0.4; 0.1; 0.2; 0.4; 0.2 | — |
| SECONDARY Ear or Palate Pruritus (Itchy Ear or Palate) |
0.1; 0.3; 0.2; 0.3; 0.6; 0.3 | — |
| SECONDARY Nasal Congestion |
0.2; 0.6; 0.3; 0.3; 0.6; 0.3 | — |
| SECONDARY Total Non-Ocular Composite Symptom |
0.6; 2.2; 0.7; 1.0; 2.7; 1.1 | — |
| SECONDARY Tearing |
5.8; 32.6; 0.0; 5.8; 23.3; 6.8 | — |
| SECONDARY Ocular Mucus Discharge |
2.3; 0.0; 0.0; 1.2; 1.2; 0.0 | — |
Summary
Efficacy and safety study of bepotastine besilate ophthalmic solution in allergic conjunctivitis
Eligibility Criteria
Inclusion Criteria
- Subjects must be at least 10 years of age
Exclusion Criteria
- No active ocular disease
Data sourced from ClinicalTrials.gov (NCT00586664). 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.