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

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01174823
• Collaborator: (none)
• Enrollment: 245
• Location: 1
• Arms: 2
• Duration (Months): 6
• Patients Per Site Per Month: 40.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Allergic Conjunctivitis	Drug: bepotastine besilate ophthalmic solution; Drug: placebo comparator ophthalmic solution	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 245 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Jun 1, 2010
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bepotastine Besilate Ophthalmic Solution	Drug: bepotastine besilate ophthalmic solution; sterile ophthalmic solution
Placebo Comparator: Placebo	Drug: placebo comparator ophthalmic solution; sterile ophthalmic solution

Outcome Measures

Primary Outcome Measures

1. Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Mean Change in Total Score [Baseline, 14 days]

   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.

Secondary Outcome Measures

1. Mean Change From Baseline for Twice Daily (BID) Averaged Reflective Ocular Itching Scores Over the Treatment Period [Baseline, 14 days]

   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).

2. Mean Change From Baseline for Twice Daily (BID) Averaged Instantaneous Ocular Redness Scores Over the Treatment Period [Baseline, 14 days]

   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).

3. Mean Change From Baseline for Twice Daily (BID) Averaged Proportion of Tearing Episodes Over the Treatment Period [Baseline, 14 days]

   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.

4. Mean Change From Baseline for Twice Daily (BID) Averaged Reflective Total Nasal Symptom Scores Over the Treatment Period [Baseline, 14 days]

   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

5. Global Therapeutic Response Rating - Participant Assessed [14 days]

   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'.

6. Global Therapeutic Response Rating - Investigator Assessed [14 days]

   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'.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• No active ocular or nasal infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ISTA Pharmaceuticals, Inc.	Irvine	California	United States	92618

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

• Study Director: Tim McNamara, PharmD, ISTA Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT01174823
• Other Study ID Numbers: S00041
• First Posted: Aug 4, 2010
• Last Update Posted: Sep 14, 2020
• Last Verified: Sep 1, 2020

• Additional relevant MeSH terms: Conjunctivitis; Conjunctivitis, Allergic; Bepotastine besilate; Pharmaceutical Solutions; Ophthalmic Solutions

Study Results

Participant Flow

Arm/Group Title	Placebo	Bepotastine Besilate Ophthalmic Solution
Arm/Group Description	placebo comparator ophthalmic solution: sterile ophthalmic solution administered twice a day	bepotastine besilate ophthalmic solution: sterile ophthalmic solution administered twice a day
Period Title: Overall Study
STARTED	122	123
COMPLETED	115	119
NOT COMPLETED	7	4

Baseline Characteristics

Arm/Group Title	Placebo	Bepotastine Besilate Ophthalmic Solution	Total
Arm/Group Description	placebo comparator ophthalmic solution: sterile ophthalmic solution administered twice a day	bepotastine besilate ophthalmic solution: sterile ophthalmic solution administered twice a day	Total of all reporting groups
Overall Participants	122	123	245
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.6 (15.0)	38.7 (13.8)	40.1 (14.5)
Sex: Female, Male (Count of Participants)
Female	82 67.2%	71 57.7%	153 62.4%
Male	40 32.8%	52 42.3%	92 37.6%

Outcome Measures

1. Primary Outcome

Title	Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Mean Change in Total Score
Description	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

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Placebo	Bepotastine Besilate Ophthalmic Solution
Arm/Group Description	placebo comparator ophthalmic solution: sterile ophthalmic solution administered twice a day	bepotastine besilate ophthalmic solution: sterile ophthalmic solution administered twice a day
Measure Participants	107	109
Mean (Standard Deviation) [score on a scale]	-1.18 (1.24)	-1.17 (1.27)

2. Secondary Outcome

Title	Mean Change From Baseline for Twice Daily (BID) Averaged Reflective Ocular Itching Scores Over the Treatment Period
Description	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

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Placebo	Bepotastine Besilate Ophthalmic Solution
Arm/Group Description	placebo comparator ophthalmic solution: sterile ophthalmic solution administered twice a day	bepotastine besilate ophthalmic solution: sterile ophthalmic solution administered twice a day
Measure Participants	107	109
Mean (Standard Deviation) [score on a scale]	-0.54 (0.58)	-0.71 (0.65)

3. Secondary Outcome

Title	Mean Change From Baseline for Twice Daily (BID) Averaged Instantaneous Ocular Redness Scores Over the Treatment Period
Description	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

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Placebo	Bepotastine Besilate Ophthalmic Solution
Arm/Group Description	placebo comparator ophthalmic solution: sterile ophthalmic solution administered twice a day	bepotastine besilate ophthalmic solution: sterile ophthalmic solution administered twice a day
Measure Participants	107	109
Mean (Standard Deviation) [score on a scale]	-0.45 (0.61)	-0.62 (0.57)

4. Secondary Outcome

Title	Mean Change From Baseline for Twice Daily (BID) Averaged Proportion of Tearing Episodes Over the Treatment Period
Description	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

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Placebo	Bepotastine Besilate Ophthalmic Solution
Arm/Group Description	placebo comparator ophthalmic solution: sterile ophthalmic solution administered twice a day	bepotastine besilate ophthalmic solution: sterile ophthalmic solution administered twice a day
Measure Participants	107	109
Mean (Standard Deviation) [tearing episodes]	-0.15 (0.244)	-0.18 (0.269)

5. Secondary Outcome

Title	Mean Change From Baseline for Twice Daily (BID) Averaged Reflective Total Nasal Symptom Scores Over the Treatment Period
Description	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

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Placebo	Bepotastine Besilate Ophthalmic Solution
Arm/Group Description	placebo comparator ophthalmic solution: sterile ophthalmic solution administered twice a day	bepotastine besilate ophthalmic solution: sterile ophthalmic solution administered twice a day
Measure Participants	107	109
Mean (Standard Deviation) [score on a scale]	-1.73 (1.94)	-2.08 (2.06)

6. Secondary Outcome

Title	Global Therapeutic Response Rating - Participant Assessed
Description	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

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Placebo	Bepotastine Besilate Ophthalmic Solution
Arm/Group Description	placebo comparator ophthalmic solution: sterile ophthalmic solution administered twice a day	bepotastine besilate ophthalmic solution: sterile ophthalmic solution administered twice a day
Measure Participants	107	109
Improved or Marked Improvement	24 19.7%	27 22%
Any Improvement	64 52.5%	72 58.5%

7. Secondary Outcome

Title	Global Therapeutic Response Rating - Investigator Assessed
Description	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

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Placebo	Bepotastine Besilate Ophthalmic Solution
Arm/Group Description	placebo comparator ophthalmic solution: sterile ophthalmic solution administered twice a day	bepotastine besilate ophthalmic solution: sterile ophthalmic solution administered twice a day
Measure Participants	107	109
Improved or Marked Improvement	16 13.1%	29 23.6%
Any Improvement	56 45.9%	70 56.9%

Adverse Events

Time Frame	14 days
Adverse Event Reporting Description	The analysis population for the adverse events was randomized participants who received at least one dose of study treatment.
Arm/Group Title	Placebo		Bepotastine Besilate Ophthalmic Solution
Arm/Group Description	placebo comparator ophthalmic solution: sterile ophthalmic solution		bepotastine besilate ophthalmic solution: sterile ophthalmic solution
All Cause Mortality
	Placebo		Bepotastine Besilate Ophthalmic Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/121 (0%)		0/123 (0%)
Serious Adverse Events
	Placebo		Bepotastine Besilate Ophthalmic Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/121 (0.8%)		0/123 (0%)
Infections and infestations
Localized infection	1/121 (0.8%)		0/123 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Bepotastine Besilate Ophthalmic Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/121 (0.8%)		10/123 (8.1%)
General disorders
Mild taste following instillation	1/121 (0.8%)		10/123 (8.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Contact sponsor directly for details.