Safety and Efficacy of Bepotastine Besilate Ophthalmic Solution in Allergic Conjunctivitis Patients
This study has been completed.
Sponsor:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01174823
First received: August 2, 2010
Last updated: February 4, 2013
Last verified: February 2013
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| Tracking Information | |||||
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| First Received Date ICMJE | August 2, 2010 | ||||
| Last Updated Date | February 4, 2013 | ||||
| Start Date ICMJE | June 2010 | ||||
| Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Rhinoconjunctivitis quality of life questionnaire [ Time Frame: Day -7 to Day 14 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01174823 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Safety and Efficacy of Bepotastine Besilate Ophthalmic Solution in Allergic Conjunctivitis Patients | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | The purpose of this study is to study the safety and efficacy of bepotastine besilate ophthalmic solution in allergic conjunctivitis patients. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Allergic Conjunctivitis | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 240 | ||||
| Completion Date | December 2010 | ||||
| Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 12 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01174823 | ||||
| Other Study ID Numbers ICMJE | S00041 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Bausch & Lomb Incorporated | ||||
| Study Sponsor ICMJE | Bausch & Lomb Incorporated | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Bausch & Lomb Incorporated | ||||
| Verification Date | February 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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