Use of Loteprednol for Contact Lens Intolerance and Dryness

This study is enrolling participants by invitation only.

First Received: January 2, 2009 Last Updated: January 5, 2009 History of Changes

Sponsors and Collaborators:	Hom, Milton M., OD, FAAO Bausch & Lomb, Inc.
Information provided by:	Hom, Milton M., OD, FAAO
ClinicalTrials.gov Identifier:	NCT00817557

Purpose

Study of the effects of Loteprednol on CL dryness

Condition	Intervention	Phase
Contact Lenses Dryness	Drug: Loteprednol Other: Rewetter	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Crossover Assignment, Efficacy Study
Official Title:	Use of Loteprednol for Contact Lens Intolerance and Dryness

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear

Drug Information available for: Loteprednol etabonate Loteprednol

Further study details as provided by Hom, Milton M., OD, FAAO:

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment:	25
Study Start Date:	January 2009
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Loteprednol: Active Comparator Loteprednol BID	Drug: Loteprednol Anti-inflammatory
Rewetter: Placebo Comparator Rewetter BID	Other: Rewetter

Eligibility

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00817557

Locations

United States, California
Milton M. Hom, OD, FAAO.
Azusa, California, United States, 91702

Sponsors and Collaborators

Hom, Milton M., OD, FAAO

Bausch & Lomb, Inc.

Investigators

Principal Investigator:

Milton M Hom, OD FAAO

Private Practice

More Information

No publications provided

Responsible Party:	Private Practice ( Milton M. Hom, OD, FAAO. )
Study ID Numbers:	05
Study First Received:	January 2, 2009
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00817557 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Hom, Milton M., OD, FAAO:

Contact lenses
Loteprednol
Effect on CL dryness

Study placed in the following topic categories:

Anti-Allergic Agents
Loteprednol etabonate

Additional relevant MeSH terms:

Therapeutic Uses
Anti-Allergic Agents
Loteprednol etabonate
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 02, 2009