Use of Loteprednol for Contact Lens Intolerance and Dryness

Tracking Information
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; (submitted: January 5, 2009)	Wearing time [ Time Frame: 28 days ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ICMJE; (submitted: January 5, 2009)	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
Condition ICMJE	Contact Lenses Dryness
Intervention ICMJE	Drug: Loteprednol Anti-inflammatory; Other: Rewetter
Study Arms	Active Comparator: Loteprednol Loteprednol BID Intervention: Drug: Loteprednol; Placebo Comparator: Rewetter Rewetter BID Intervention: Other: Rewetter
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: January 5, 2009)	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: Between the ages of 18 and over inclusive.; Males or females; Any race or ethnic background; CL history- experienced intolerance and either switched solutions or lenses without satisfactory relief.; Patient is in generally good & stable overall health.; Patient likely to comply with study guidelines & study visits.; Informed consent signed.; OSDI score 18 or higher while wearing lenses; Unsatisfactory wearing time with contact lenses Exclusion Criteria: Corneal refractive surgery within 6 months of this study.; Contact lens use on day of examination.; Corneal ectasia.; Current use of Restasis; Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.; Pregnant or lactating women.; Ocular pathology (includes glaucoma and cataract) which could impact results and/or place patient at risk.
Sex/Gender	Sexes Eligible for Study: All
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	Principal Investigator: Milton M Hom, OD FAAO Private Practice
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