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

Allergic Conjunctivitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01174823
• Other study ID #: S00041
• Status: Completed
• Phase: Phase 2
• Start date: June 2010
• Est. completion date: December 2010

Study information

• Verified date: September 2020
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: December 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Subjects 12 years of age and older with 2-year history of allergic conjunctivitis

Exclusion Criteria:

• No active ocular or nasal infection

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• bepotastine besilate ophthalmic solution
sterile ophthalmic solution
• placebo comparator ophthalmic solution
sterile ophthalmic solution

Locations

Country	Name	City	State
United States	ISTA Pharmaceuticals, Inc.	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Mean Change in Total Score	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.	Baseline, 14 days
Secondary	Mean Change From Baseline for Twice Daily (BID) Averaged Reflective Ocular Itching Scores Over the Treatment Period	Ocular itching was graded on a 4-point scale (0-3 units; 0=Absent, 1=Mild, 2=Moderate, 3=Severe) twice daily in the Screening Diary (Day -7 to Day -1) and the Subject Diary (Day 0 prior to first dose through Day 13).	Baseline, 14 days
Secondary	Mean Change From Baseline for Twice Daily (BID) Averaged Instantaneous Ocular Redness Scores Over the Treatment Period	Ocular redness each was graded on a 4-point scale (0-3 units; 0=Absent, 1=Mild, 2=Moderate, 3=Severe) twice daily in the Screening Diary (Day -7 to Day -1) and the Subject Diary (Day 0 prior to first dose through Day 13).	Baseline, 14 days
Secondary	Mean Change From Baseline for Twice Daily (BID) Averaged Proportion of Tearing Episodes Over the Treatment Period	Individual nasal symptoms and ocular itching and redness each were graded on a 4-point scale (0-3 units; 0=Absent, 1=Mild, 2=Moderate, 3=Severe) BID in the Screening Diary (Day -7 to Day -1) and BID in the Subject Diary (Day 0 prior to first dose through Day 13). Tearing was scored from Day 0 as either absent or present at the same time as nasal and other ocular symptoms were graded. The proportion of participants was calculated and then then average of the proportions.	Baseline, 14 days
Secondary	Mean Change From Baseline for Twice Daily (BID) Averaged Reflective Total Nasal Symptom Scores Over the Treatment Period	Individual nasal symptoms of rhinorrhea, nasal congestion, nasal itching, and sneezing each were each graded on a 4-point scale (0-3 units; 0=Absent, 1=Mild, 2=Moderate, 3=Severe) twice daily in the Screening Diary (Day -7 to Day -1) and the Subject Diary (Day 0 prior to first dose through Day 13). The minimum Total Nasal Symptom Score (TNSS) was 0 units and the maximum TNSS corresponding to multiple individual nasal symptoms scored as severe was 12 units	Baseline, 14 days
Secondary	Global Therapeutic Response Rating - Participant Assessed	Participants were asked if they felt that they had experienced improvement in allergy symptoms after therapy. Participant assessed global therapeutic response rating: categories that the participant could select were 'no change', 'slight improvement', 'improved', or 'marked improvement'.	14 days
Secondary	Global Therapeutic Response Rating - Investigator Assessed	Investigators were asked if they felt that the participant had experienced improvement in allergy symptoms after therapy. Investigator assessed global therapeutic response rating: categories that the investigator could select were 'no change', 'slight improvement', 'improved', or 'marked improvement'.	14 days