Use of Loteprednol for Contact Lens Intolerance and Dryness

This study is enrolling participants by invitation only.

Sponsor:

Collaborator:

Bausch & Lomb Incorporated

Information provided by:

Hom, Milton M., OD, FAAO

ClinicalTrials.gov Identifier:

NCT00817557

First received: January 2, 2009

Last updated: January 5, 2009

Last verified: January 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

January 2, 2009

Last Updated Date

January 5, 2009

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

OSDI [ Time Frame: 28 days ] [ Designated as safety issue: No ]

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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Contact Lenses Dryness

Intervention ^ICMJE

Drug: Loteprednol
Anti-inflammatory
Other: Rewetter

Study Arm (s)

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

Enrolling by invitation

Estimated Enrollment ^ICMJE

Estimated 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.

Gender

Both

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

Has Data Monitoring Committee

Yes

Plan to Share Data

Not Provided

IPD Description

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

Information Provided By

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

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