Use of Loteprednol for Contact Lens Intolerance and Dryness

NCT ID: NCT00817557

Last Updated: 2009-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-09-30

Brief Summary

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Study of the effects of Loteprednol on CL dryness

Detailed Description

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Conditions

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Contact Lenses Dryness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Loteprednol

Loteprednol BID

Group Type ACTIVE_COMPARATOR

Loteprednol

Intervention Type DRUG

Anti-inflammatory

Rewetter

Rewetter BID

Group Type PLACEBO_COMPARATOR

Rewetter

Intervention Type OTHER

Interventions

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Loteprednol

Anti-inflammatory

Intervention Type DRUG

Rewetter

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Between the ages of 18 and over inclusive.
2. Males or females
3. Any race or ethnic background
4. CL history- experienced intolerance and either switched solutions or lenses without satisfactory relief.
5. Patient is in generally good \& stable overall health.
6. Patient likely to comply with study guidelines \& study visits.
7. Informed consent signed.
8. OSDI score 18 or higher while wearing lenses
9. Unsatisfactory wearing time with contact lenses

Exclusion Criteria

1. Corneal refractive surgery within 6 months of this study.
2. Contact lens use on day of examination.
3. Corneal ectasia.
4. Current use of Restasis
5. Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.
6. Pregnant or lactating women.
7. Ocular pathology (includes glaucoma and cataract) which could impact results and/or place patient at risk.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role collaborator

Hom, Milton M., OD, FAAO

INDIV

Sponsor Role lead

Responsible Party

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Private Practice

Principal Investigators

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Milton M Hom, OD FAAO

Role: PRINCIPAL_INVESTIGATOR

Private Practice

Locations

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Milton M. Hom, OD, FAAO.

Azusa, California, United States

Site Status

Countries

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United States

Other Identifiers

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05

Identifier Type: -

Identifier Source: org_study_id

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