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Corticosteroid
A Phase IV, Randomized, Parallel Group, Investigator-Masked Evaluation of the Effect of Loteprednol Etabonate Ophthalmic Gel 0.5% on the Initiation of Dry Eye Treatment With Restasis®
Phase 4
Waitlist Available
Research Sponsored by Edward Holland, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
All Individual Drugs Already Approved
Approved for 20 Other Conditions
Summary
A pilot study to evaluate the impact of Lotemax® Gel (loteprednol etabonate ophthalmic gel 0.5%) on the initiation of Restasis® (cyclosporine ophthalmic emulsion 0.05%) therapy in subjects with dry eye.
Eligible Conditions
- Dry Eye Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Loteprednol etabonate + RestasisActive Control2 Interventions
Loteprednol Etabonate Ophthalmic Gel 0.5%, BID 30 days Restasis, BID 45 days
Group II: Artificial Tears + RestasisPlacebo Group2 Interventions
Artificial Tears, BID 30 days Restasis, BID 45 days
Find a Location
Who is running the clinical trial?
Edward Holland, MDLead Sponsor