Use of Loteprednol for Contact Lens Intolerance and Dryness

Hom, Milton M., OD, FAAO

Status and phase: Unknown; Phase 4

Conditions: Contact Lenses Dryness

Treatments: Drug: Loteprednol; Other: Rewetter

Study type: Interventional

Funder types: Industry

Identifiers

NCT00817557

05

Details and patient eligibility

About

Study of the effects of Loteprednol on CL dryness

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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25 participants in 2 patient groups, including a placebo group

Loteprednol

Active Comparator group

Description:

Loteprednol BID

Treatment:

Drug: Loteprednol

Rewetter

Placebo Comparator group

Description:

Rewetter BID

Treatment:

Other: Rewetter