Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01174823
Recruitment Status : Completed
First Posted : August 4, 2010
Results First Posted : September 14, 2020
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 245 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : June 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye
Drug Information available for: Bepotastine

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




Primary Outcome Measures :
  1. Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Mean Change in Total Score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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'.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01174823


Locations
Layout table for location information
United States, California
ISTA Pharmaceuticals, Inc.
Irvine, California, United States, 92618
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Layout table for investigator information
Study Director: Tim McNamara, PharmD ISTA Pharmaceuticals, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01174823    
Other Study ID Numbers: S00041
First Posted: August 4, 2010    Key Record Dates
Results First Posted: September 14, 2020
Last Update Posted: September 14, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
Layout table for MeSH terms
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Bepotastine besilate
Pharmaceutical Solutions
Ophthalmic Solutions
Anti-Allergic Agents