Safety and Efficacy of an Ophthalmic Solution in Dry Eye Disease
This study has been completed.
Sponsor:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00758784
First received: September 19, 2008
Last updated: January 3, 2013
Last verified: January 2013
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| Tracking Information | |||||
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| First Received Date ICMJE | September 19, 2008 | ||||
| Last Updated Date | January 3, 2013 | ||||
| Start Date ICMJE | August 2008 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Ocular staining [ Time Frame: 2 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00758784 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 an Ophthalmic Solution in Dry Eye Disease | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | The purpose of this study is to investigate the safety and efficacy of an ophthalmic solution in dry eye disease. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Dry Eye Disease | ||||
| Intervention ICMJE | Drug: Refresh Tears
sterile ophthalmic solution |
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| Study Arm (s) | Experimental: 1
Intervention: Drug: Refresh Tears |
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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 | 38 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 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 | NCT00758784 | ||||
| Other Study ID Numbers ICMJE | CL-S&E-0417082-P | ||||
| 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 | January 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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