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Novel Use of Cyclosporine Ophthalmic Emulsion 0.05% in a PROSE Device

NCT04918823 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-01-13

Study results available
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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.

Conditions

  • Ocular Surface Disease

Interventions

DRUG

Restasis

Subject will use one drop of Restasis in the lens before insertion

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • Boston Sight

    lead OTHER

Principal Investigators

  • Daniel C Brocks, MD · Boston Sight

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-15
Primary Completion
2023-04-04
Completion
2023-04-14
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 NCT04918823 on ClinicalTrials.gov