Phase 2 N=245 Randomized Double-blind Treatment

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

Allergic Conjunctivitis

Bottom Line

View on ClinicalTrials.gov: NCT01174823 ↗

Enrolled (actual)

245

Serious AEs

0.4%

Results posted

Sep 2020

Primary outcome: Primary: Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Mean Change in Total Score — -1.18; -1.17 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: bepotastine besilate ophthalmic solution (Drug); placebo comparator ophthalmic solution (Drug)
Age: Pediatric, Adult, Older Adult · 12+ yrs
Sex: All
Sponsor: Bausch & Lomb Incorporated
Primary completion: Oct 2010

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	—

Summary

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

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

View full record on ClinicalTrials.gov →

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.