Use of Loteprednol for Contact Lens Intolerance and Dryness

Phase 4

• Conditions: Contact Lenses Dryness
• Interventions: Other: Rewetter; Drug: Loteprednol

• Registration Number: NCT00817557
• Lead Sponsor: Hom, Milton M., OD, FAAO

Brief Summary

Study of the effects of Loteprednol on CL dryness

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-01
• Study Start: 2009-01
• Study First Submitted: 2009-01-02
• Study First Submitted QC: 2009-01-05
• Last Update Submitted: 2009-01-05
• Study First Posted: 2009-01-06
• Last Update Posted: 2009-01-06
• Primary Completion: 2009-06
• Study Completion: 2009-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Rewetter	Rewetter	Rewetter BID
Loteprednol	Loteprednol	Loteprednol BID

Primary Outcome Measures

Name	Time	Method
Wearing time	28 days

Secondary Outcome Measures

Name	Time	Method
OSDI	28 days

Trial Locations

Locations (1)

Milton M. Hom, OD, FAAO.; 🇺🇸 Azusa, California, United States