Trial Outcomes & Findings for Safety and Efficacy of Bepotastine Besilate Ophthalmic Solution in Seasonal Allergic Conjunctivitis Patients (NCT NCT01174823)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

245 participants

Primary outcome timeframe

Baseline, 14 days

Results posted on

2020-09-14

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo placebo comparator ophthalmic solution: sterile ophthalmic solution administered twice a day	Bepotastine Besilate Ophthalmic Solution bepotastine besilate ophthalmic solution: sterile ophthalmic solution administered twice a day
Overall Study STARTED	122	123
Overall Study COMPLETED	115	119
Overall Study NOT COMPLETED	7	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=122 Participants placebo comparator ophthalmic solution: sterile ophthalmic solution administered twice a day	Bepotastine Besilate Ophthalmic Solution n=123 Participants bepotastine besilate ophthalmic solution: sterile ophthalmic solution administered twice a day	Total n=245 Participants Total of all reporting groups
Age, Continuous	41.6 years STANDARD_DEVIATION 15.0 • n=5 Participants	38.7 years STANDARD_DEVIATION 13.8 • n=7 Participants	40.1 years STANDARD_DEVIATION 14.5 • n=5 Participants
Sex: Female, Male Female	82 Participants n=5 Participants	71 Participants n=7 Participants	153 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	52 Participants n=7 Participants	92 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Placebo n=107 Participants placebo comparator ophthalmic solution: sterile ophthalmic solution administered twice a day	Bepotastine Besilate Ophthalmic Solution n=109 Participants bepotastine besilate ophthalmic solution: sterile ophthalmic solution administered twice a day
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Mean Change in Total Score	-1.18 score on a scale Standard Deviation 1.24	-1.17 score on a scale Standard Deviation 1.27

SECONDARY outcome

Timeframe: 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).

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).

Outcome measures

Outcome measures
Measure	Placebo n=107 Participants placebo comparator ophthalmic solution: sterile ophthalmic solution administered twice a day	Bepotastine Besilate Ophthalmic Solution n=109 Participants bepotastine besilate ophthalmic solution: sterile ophthalmic solution administered twice a day
Mean Change From Baseline for Twice Daily (BID) Averaged Reflective Ocular Itching Scores Over the Treatment Period	-0.54 score on a scale Standard Deviation 0.58	-0.71 score on a scale Standard Deviation 0.65

SECONDARY outcome

Timeframe: 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).

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).

Outcome measures

Outcome measures
Measure	Placebo n=107 Participants placebo comparator ophthalmic solution: sterile ophthalmic solution administered twice a day	Bepotastine Besilate Ophthalmic Solution n=109 Participants bepotastine besilate ophthalmic solution: sterile ophthalmic solution administered twice a day
Mean Change From Baseline for Twice Daily (BID) Averaged Instantaneous Ocular Redness Scores Over the Treatment Period	-0.45 score on a scale Standard Deviation 0.61	-0.62 score on a scale Standard Deviation 0.57

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Placebo n=107 Participants placebo comparator ophthalmic solution: sterile ophthalmic solution administered twice a day	Bepotastine Besilate Ophthalmic Solution n=109 Participants bepotastine besilate ophthalmic solution: sterile ophthalmic solution administered twice a day
Mean Change From Baseline for Twice Daily (BID) Averaged Proportion of Tearing Episodes Over the Treatment Period	-0.15 tearing episodes Standard Deviation 0.244	-0.18 tearing episodes Standard Deviation 0.269

SECONDARY outcome

Timeframe: 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).

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

Outcome measures

Outcome measures
Measure	Placebo n=107 Participants placebo comparator ophthalmic solution: sterile ophthalmic solution administered twice a day	Bepotastine Besilate Ophthalmic Solution n=109 Participants bepotastine besilate ophthalmic solution: sterile ophthalmic solution administered twice a day
Mean Change From Baseline for Twice Daily (BID) Averaged Reflective Total Nasal Symptom Scores Over the Treatment Period	-1.73 score on a scale Standard Deviation 1.94	-2.08 score on a scale Standard Deviation 2.06

SECONDARY outcome

Timeframe: 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'.

Outcome measures

Outcome measures
Measure	Placebo n=107 Participants placebo comparator ophthalmic solution: sterile ophthalmic solution administered twice a day	Bepotastine Besilate Ophthalmic Solution n=109 Participants bepotastine besilate ophthalmic solution: sterile ophthalmic solution administered twice a day
Global Therapeutic Response Rating - Participant Assessed Improved or Marked Improvement	24 Participants	27 Participants
Global Therapeutic Response Rating - Participant Assessed Any Improvement	64 Participants	72 Participants

SECONDARY outcome

Timeframe: 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'.

Outcome measures

Outcome measures
Measure	Placebo n=107 Participants placebo comparator ophthalmic solution: sterile ophthalmic solution administered twice a day	Bepotastine Besilate Ophthalmic Solution n=109 Participants bepotastine besilate ophthalmic solution: sterile ophthalmic solution administered twice a day
Global Therapeutic Response Rating - Investigator Assessed Improved or Marked Improvement	16 Participants	29 Participants
Global Therapeutic Response Rating - Investigator Assessed Any Improvement	56 Participants	70 Participants

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Bepotastine Besilate Ophthalmic Solution

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=121 participants at risk placebo comparator ophthalmic solution: sterile ophthalmic solution	Bepotastine Besilate Ophthalmic Solution n=123 participants at risk bepotastine besilate ophthalmic solution: sterile ophthalmic solution
Infections and infestations Localized infection	0.83% 1/121 • 14 days The analysis population for the adverse events was randomized participants who received at least one dose of study treatment.	0.00% 0/123 • 14 days The analysis population for the adverse events was randomized participants who received at least one dose of study treatment.

Other adverse events

Other adverse events
Measure	Placebo n=121 participants at risk placebo comparator ophthalmic solution: sterile ophthalmic solution	Bepotastine Besilate Ophthalmic Solution n=123 participants at risk bepotastine besilate ophthalmic solution: sterile ophthalmic solution
General disorders Mild taste following instillation	0.83% 1/121 • 14 days The analysis population for the adverse events was randomized participants who received at least one dose of study treatment.	8.1% 10/123 • 14 days The analysis population for the adverse events was randomized participants who received at least one dose of study treatment.

Additional Information

Study Director

Bausch Health

Phone: 908-300-9920

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Contact sponsor directly for details.
Publication restrictions are in place

Restriction type: OTHER