NCT04735510

Novel Use of Restasis and PROSE Devices

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Boston Sight · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Detailed description

For this study, all subjects will receive Restasis (Cyclosporine ophthalmic emulsion 0.05%). One drop of the dispensed study drop will be instilled in the PROSE lens reservoir twice a day and the remainder of the reservoir will be filled with normal saline (0.9% sodium chloride solution). In order to standardize solutions used in the PROSE reservoir, all patients recruited will be either currently using or will be switched to buffered preservative-free normal saline (Purilens, Lifestyle Inc., pH 7.4 ) to better match the reported pH of RESTASIS (pH 6.5-8.05).

Conditions

• Ocular Surface Disease

Interventions

Type	Name	Description
DRUG	cyclosporine ophthalmic emulsion 0.05%	All subjects will receive restasis

Timeline

• Start date: 2021-05-01
• Primary completion: 2021-09-01
• Completion: 2021-09-01
• First posted: 2021-02-03
• Last updated: 2023-04-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study