Trial · NCT01174823
Safety and Efficacy of Bepotastine Besilate Ophthalmic Solution in Seasonal Allergic Conjunctivitis Patients
NCT01174823, Phase 2, Completed, Bausch & Lomb Incorporated; results first posted 2020-09-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of Bepotastine Besilate Ophthalmic Solution in Seasonal Allergic Conjunctivitis Patients. Trials, record NCT01174823. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01174823
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Bepotastine Besilate Ophthalmic Solution in Seasonal Allergic Conjunctivitis Patients
- NCT number
- NCT01174823
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 245 participants, actual
- Lead sponsor
- Bausch & Lomb Incorporated
- Conditions
- Allergic Conjunctivitis
- Interventions
- bepotastine besilate ophthalmic solution, placebo comparator ophthalmic solution
- First posted
- 2010-08-04
- Last updated
- 2020-09-14
- Results first posted
- 2020-09-14
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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). |
| Secondary | 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). |
| Secondary | 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. |
| Secondary | 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 |
| Secondary | 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'. |
| Secondary | 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'. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Mean Change in Total Score | Baseline, 14 days | 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). | score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline for Twice Daily (BID) Averaged Reflective Ocular Itching Scores Over the Treatment Period | Baseline, 14 days | 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). | score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline for Twice Daily (BID) Averaged Instantaneous Ocular Redness Scores Over the Treatment Period | Baseline, 14 days | 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). | score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline for Twice Daily (BID) Averaged Proportion of Tearing Episodes Over the Treatment Period | Baseline, 14 days | 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). | tearing episodes | MEAN |
| SECONDARY | Mean Change From Baseline for Twice Daily (BID) Averaged Reflective Total Nasal Symptom Scores Over the Treatment Period | Baseline, 14 days | 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). | score on a scale | MEAN |
| SECONDARY | Global Therapeutic Response Rating - Participant Assessed | 14 days | 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 | COUNT_OF_PARTICIPANTS |
| SECONDARY | Global Therapeutic Response Rating - Investigator Assessed | 14 days | 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 | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Mean Change in Total Score | Placebo | -1.18 | Standard Deviation 1.24 | score on a scale | |
| Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Mean Change in Total Score | Bepotastine Besilate Ophthalmic Solution | -1.17 | Standard Deviation 1.27 | score on a scale | |
| Mean Change From Baseline for Twice Daily (BID) Averaged Reflective Ocular Itching Scores Over the Treatment Period | Placebo | -0.54 | Standard Deviation 0.58 | score on a scale | |
| Mean Change From Baseline for Twice Daily (BID) Averaged Reflective Ocular Itching Scores Over the Treatment Period | Bepotastine Besilate Ophthalmic Solution | -0.71 | Standard Deviation 0.65 | score on a scale | |
| Mean Change From Baseline for Twice Daily (BID) Averaged Instantaneous Ocular Redness Scores Over the Treatment Period | Placebo | -0.45 | Standard Deviation 0.61 | score on a scale | |
| Mean Change From Baseline for Twice Daily (BID) Averaged Instantaneous Ocular Redness Scores Over the Treatment Period | Bepotastine Besilate Ophthalmic Solution | -0.62 | Standard Deviation 0.57 | score on a scale | |
| Mean Change From Baseline for Twice Daily (BID) Averaged Proportion of Tearing Episodes Over the Treatment Period | Placebo | -0.15 | Standard Deviation 0.244 | tearing episodes | |
| Mean Change From Baseline for Twice Daily (BID) Averaged Proportion of Tearing Episodes Over the Treatment Period | Bepotastine Besilate Ophthalmic Solution | -0.18 | Standard Deviation 0.269 | tearing episodes | |
| Mean Change From Baseline for Twice Daily (BID) Averaged Reflective Total Nasal Symptom Scores Over the Treatment Period | Placebo | -1.73 | Standard Deviation 1.94 | score on a scale | |
| Mean Change From Baseline for Twice Daily (BID) Averaged Reflective Total Nasal Symptom Scores Over the Treatment Period | Bepotastine Besilate Ophthalmic Solution | -2.08 | Standard Deviation 2.06 | score on a scale |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 122 | |
| Overall Study | STARTED | Bepotastine Besilate Ophthalmic Solution | 123 | |
| Overall Study | COMPLETED | Placebo | 115 | |
| Overall Study | COMPLETED | Bepotastine Besilate Ophthalmic Solution | 119 | |
| Overall Study | NOT COMPLETED | Placebo | 7 | |
| Overall Study | NOT COMPLETED | Bepotastine Besilate Ophthalmic Solution | 4 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Mild taste following instillation | General disorders | Placebo | 1 | 121 | |
| other | Mild taste following instillation | General disorders | Bepotastine Besilate Ophthalmic Solution | 10 | 123 | |
| serious | Localized infection | Infections and infestations | Placebo | 1 | 121 | |
| serious | Localized infection | Infections and infestations | Bepotastine Besilate Ophthalmic Solution | 0 | 123 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 121 |
| Total, all-cause mortality | Bepotastine Besilate Ophthalmic Solution | 0 | 123 |
| Total, other adverse events | Placebo | 1 | 121 |
| Total, other adverse events | Bepotastine Besilate Ophthalmic Solution | 10 | 123 |
| Total, serious adverse events | Placebo | 1 | 121 |
| Total, serious adverse events | Bepotastine Besilate Ophthalmic Solution | 0 | 123 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23484763 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Bepotastine Besilate Ophthalmic Solution vs Placebo: deaths from any cause | Trial comparisons |
| Bepotastine Besilate Ophthalmic Solution vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01174823
GET https://conductscience.org/api/trials/v1/NCT01174823/registered