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

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.

Time frame: Baseline, 14 days

Population: The per protocol population included randomized participants with no major protocol violations, who had at least 80% dosing compliance during the 2-week dosing period and at least 85% compliance in providing nasal and ocular symptom grades in the Subject Diary, and who completed the RQLQ at Day 0 and Day 14 (+2).

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'.

Time frame: 14 days

Population: The per protocol population included randomized participants with no major protocol violations, who had at least 80% dosing compliance during the 2-week dosing period and at least 85% compliance in providing nasal and ocular symptom grades in the Subject Diary, and who completed the RQLQ at Day 0 and Day 14 (+2).

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'.

Time frame: 14 days

Population: The per protocol population included randomized participants with no major protocol violations, who had at least 80% dosing compliance during the 2-week dosing period and at least 85% compliance in providing nasal and ocular symptom grades in the Subject Diary, and who completed the RQLQ at Day 0 and Day 14 (+2).

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).

Time frame: Baseline, 14 days

Population: The per protocol population included randomized participants with no major protocol violations, who had at least 80% dosing compliance during the 2-week dosing period and at least 85% compliance in providing nasal and ocular symptom grades in the Subject Diary, and who completed the RQLQ at Day 0 and Day 14 (+2).

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.

Time frame: Baseline, 14 days

Population: The per protocol population included randomized participants with no major protocol violations, who had at least 80% dosing compliance during the 2-week dosing period, who had at least 85% compliance in providing nasal and ocular symptom grades in the Subject Diary, and who completed the questionnaire at Day 0 and Day 14 (+2).

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).

Time frame: Baseline, 14 days

Population: The per protocol population included randomized participants with no major protocol violations, who had at least 80% dosing compliance during the 2-week dosing period and at least 85% compliance in providing nasal and ocular symptom grades in the Subject Diary, and who completed the RQLQ at Day 0 and Day 14 (+2).

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

Time frame: Baseline, 14 days

Population: The per protocol population included randomized participants with no major protocol violations, who had at least 80% dosing compliance during the 2-week dosing period and at least 85% compliance in providing nasal and ocular symptom grades in the Subject Diary, and who completed the questionnaire at Day 0 and Day 14 (+2).