Phase 2 Study of a New Ophthalmic Formulation of Cyclosporine (Restasis® X) in Patients With Dry Eye Disease
- Conditions
- Dry Eye Syndromes
- Interventions
- Registration Number
- NCT02013791
- Lead Sponsor
- Allergan
- Brief Summary
This study will evaluate a new ophthalmic formulation of cyclosporine (Restasis® X) in patients with moderate to severe dry eye disease in two stages. Up to 3 doses will be studied in Stage 2 based on results from Stage 1. No patients participating in Stage 1 will participate in Stage 2 of this study. This study was terminated and Stage 2 of the study was cancelled.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 55
- Moderate to severe dry eye disease in both eyes
- Best-corrected visual acuity (BCVA) of 20/100 or better in each eye
- Use of any cyclosporine preparations within 3 months
- Use of topical medications, other than artificial tears, in the eyes within 1 month
- Use of contact lenses in either eye within 1 month
- Stage 2 only: Participation in Stage 1 of this study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stage 1 Cohort 2 Cyclosporine New Ophthalmic Formulation Cyclosporine New Ophthalmic Formulation Dose A administered to study eye and Vehicle administered to non-study eye on Day 1. Stage 1 Cohort 6D Cyclosporine New Ophthalmic Formulation Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable. Stage 1 Cohort 1 Vehicle Vehicle administered to study eye and Sham administered to non-study eye on Day 1. Stage 1 Cohort 1 Sham Vehicle administered to study eye and Sham administered to non-study eye on Day 1. Stage 1 Cohort 2 Vehicle Cyclosporine New Ophthalmic Formulation Dose A administered to study eye and Vehicle administered to non-study eye on Day 1. Stage 1 Cohort 3 Vehicle Cyclosporine New Ophthalmic Formulation Dose B administered to study eye and Vehicle administered to non-study eye on Day 1. Stage 1 Cohort 5A Cyclosporine New Ophthalmic Formulation Cyclosporine New Ophthalmic Formulation Dose D administered to the study eye and vehicle administered to the non-study eye on Day 1. Stage 1 Cohort 6A Vehicle Cyclosporine New Ophthalmic Formulation Dose E administered to study eye and Vehicle administered to non-study eye on Day 1. Stage 1 Cohort 3 Cyclosporine New Ophthalmic Formulation Cyclosporine New Ophthalmic Formulation Dose B administered to study eye and Vehicle administered to non-study eye on Day 1. Stage 1 Cohort 4 Vehicle Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1. Stage 1 Cohort 4 Cyclosporine New Ophthalmic Formulation Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1. Stage 1 Cohort 5A Vehicle Cyclosporine New Ophthalmic Formulation Dose D administered to the study eye and vehicle administered to the non-study eye on Day 1. Stage 1 Cohort 6A Cyclosporine New Ophthalmic Formulation Cyclosporine New Ophthalmic Formulation Dose E administered to study eye and Vehicle administered to non-study eye on Day 1. Stage 1 Cohort 6B Vehicle Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1. Stage 1 Cohort 6B Cyclosporine New Ophthalmic Formulation Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1. Stage 1 Cohort 6C Vehicle Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable. Stage 1 Cohort 6D Vehicle Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable. Stage 1 Cohort 6C Cyclosporine New Ophthalmic Formulation Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-Emergent Adverse Events (TEAEs) First dose of study drug to up to 24 Weeks An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs are AEs with an onset that occurs after receiving study drug.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Wolstan & Goldberg Eye Associates
🇺🇸Torrance, California, United States
Johns Hopkins University - Wilmer Eye Institute
🇺🇸Baltimore, Maryland, United States
Lugene Eye Institute
🇺🇸Glendale, California, United States
Eye Centers of Racine and Kenosha
🇺🇸Kenosha, Wisconsin, United States
Sall Research Medical Center
🇺🇸Artesia, California, United States
Lakeside Vision Center
🇺🇸Irvine, California, United States
Steve Yoelin MD Medical Asscociates
🇺🇸Newport Beach, California, United States
Vision Institute
🇺🇸Colorado Springs, Colorado, United States