Use of Loteprednol for Contact Lens Intolerance and Dryness
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ClinicalTrials.gov Identifier: NCT00817557 |
Recruitment Status
: Unknown
Verified January 2009 by Hom, Milton M., OD, FAAO.
Recruitment status was: Enrolling by invitation
First Posted
: January 6, 2009
Last Update Posted
: January 6, 2009
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Sponsor:
Hom, Milton M., OD, FAAO
Collaborator:
Bausch & Lomb Incorporated
Information provided by:
Hom, Milton M., OD, FAAO
Tracking Information | ||||
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First Submitted Date ICMJE | January 2, 2009 | |||
First Posted Date ICMJE | January 6, 2009 | |||
Last Update Posted Date | January 6, 2009 | |||
Study Start Date ICMJE | January 2009 | |||
Estimated Primary Completion Date | June 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Wearing time [ Time Frame: 28 days ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures ICMJE |
OSDI [ Time Frame: 28 days ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Use of Loteprednol for Contact Lens Intolerance and Dryness | |||
Official Title ICMJE | Use of Loteprednol for Contact Lens Intolerance and Dryness | |||
Brief Summary | Study of the effects of Loteprednol on CL dryness | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single (Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Contact Lenses Dryness | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* 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 | Unknown status | |||
Estimated Enrollment ICMJE |
25 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date | September 2009 | |||
Estimated Primary Completion Date | June 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00817557 | |||
Other Study ID Numbers ICMJE | 05 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Milton M. Hom, OD, FAAO., Private Practice | |||
Study Sponsor ICMJE | Hom, Milton M., OD, FAAO | |||
Collaborators ICMJE | Bausch & Lomb Incorporated | |||
Investigators ICMJE |
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PRS Account | Hom, Milton M., OD, FAAO | |||
Verification Date | January 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |