At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 10 enrolled
Drug / intervention
Restasisdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Novel Use of Restasis (Cyclosporine Ophthalmic Emulsion 0.05%) on Application of PROSE Devices for Management of Patients With Ocular Surface Disease: A Pilot Study
In Brief
A Phase 2 clinical trial evaluating Restasis for Ocular Surface Disease. Completed, enrolled 10 participants across 1 site.
Detailed Summary
The goal of this prospective observational pilot study is to evaluate the tolerability and safety of RESTASIS (cyclosporine ophthalmic solution 0.05%) when added to the PROSE (Prosthetic Replacement of the Ocular Surface Ecosystem) lens reservoir in patients with ocular surface disease (OSD). Secondary endpoints include early (1-month) efficacy data for ocular signs and symptoms.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOcular Surface Disease
CountriesUnited States
CollaboratorsAllergan
Timeline
Phase 2CompletedFinished
20222023202420252026
First PostedJun 2021
Enrollment StartJul 2021
Primary CompletionApr 2023
Study CompletionApr 2023
TodayJul 2026
First PostedJun 9, 2021
Enrollment StartJul 15, 2021
Primary CompletionApr 4, 2023
Study CompletionApr 14, 2023
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 5.1 years ago
Interventions
Restasisdrug
Subject will use one drop of Restasis in the lens before insertion