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Novel Use of Restasis and PROSE Devices

NCT04735510 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2023-04-19

No results posted yet for this study

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).

Conditions

  • Ocular Surface Disease

Interventions

DRUG

cyclosporine ophthalmic emulsion 0.05%

All subjects will receive restasis

Sponsors & Collaborators

  • Boston Sight

    lead OTHER

Principal Investigators

  • Daniel Brocks, MD · Chief Medical Officer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-31
Primary Completion
2021-09-30
Completion
2021-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04735510 on ClinicalTrials.gov