Use of Loteprednol for Contact Lens Intolerance and Dryness

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified January 2009 by Hom, Milton M., OD, FAAO.
Recruitment status was: Enrolling by invitation

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 ]

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

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

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.

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

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

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