Phase 3
N=107
Evaluation of the Onset and Duration of Action of Bepotastine Besilate Ophthalmic Solution in Acute Allergic Conjunctivitis
Conjunctivitis, Allergic
Bottom Line
View on ClinicalTrials.gov: NCT00424398 ↗Enrolled (actual)
107
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcome: Primary: Ocular Itching — 0.5; 1.9; 0.6; 0.8 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Bepreve (Drug); Placebo (Drug); Bepotastine Besilate (Drug)
- Age
- Pediatric, Adult, Older Adult · 10+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Jul 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Itching |
0.5; 1.9; 0.6; 0.8; 2.1; 0.7 | — |
| PRIMARY Conjunctival Redness |
1.4; 1.9; 1.1; 1.7; 2.1; 1.5 | — |
| SECONDARY Ciliary Redness |
1.2; 1.7; 0.9; 1.5; 1.9; 1.3 | — |
| SECONDARY Episcleral Redness |
1.3; 1.9; 1.1; 1.6; 2.1; 1.5 | — |
| SECONDARY Chemosis |
0.4; 0.7; 0.4; 0.6; 0.9; 0.5 | — |
| SECONDARY Rhinorrhea (Runny Nose) |
0.4; 0.9; 0.1; 0.5; 1.1; 0.2 | — |
| SECONDARY Nasal Pruritus (Itchy Nose) |
0.3; 0.7; 0.1; 0.2; 0.9; 0.2 | — |
| SECONDARY Ear or Palate Pruritus (Itchy Ear or Palate) |
0.3; 0.6; 0.1; 0.6; 0.9; 0.2 | — |
| SECONDARY Nasal Congestion |
0.5; 0.9; 0.2; 0.4; 1.1; 0.3 | — |
| SECONDARY Tearing |
14.3; 43.1; 6.9; 17.1; 34.7; 9.7 | — |
| SECONDARY Ocular Mucus Discharge |
0.0; 1.4; 0.0; 2.9; 0.0; 0.0 | — |
| SECONDARY Eyelid Swelling |
0.3; 0.7; 0.2; 0.3; 0.8; 0.2 | — |
| SECONDARY Total Nasal Symptom |
1.3; 3.2; 0.4; 1.7; 4.0; 0.9 | — |
Summary
The purpose of this study is to evaluate whether bepotastine besilate ophthalmic solution is effective in the treatment of acute allergic conjunctivitis
Eligibility Criteria
Inclusion Criteria
- At least 10 years of age & either sex, any race
- Willing and able to follow all instructions and attend all study visits
- Positive history of ocular allergies
Exclusion Criteria
- Have planned surgery during trial period
- Female currently pregnant, planning a pregnancy, or lactating
Data sourced from ClinicalTrials.gov (NCT00424398). 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.