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Novel Use of Restasis and PROSE Devices | Clinical Trials | Clareo Health

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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

NCT04735510•Boston Sight

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Written Informed Consent has been obtained prior to any study-related procedures taking place
•2. Subject is Male or Female, 18 years of age or older prior to the initial visit
•3. Is an established wearer of PROSE devices for \> 6 months in both eyes
•4. Has a finalized PROSE lens design in both eyes, in the opinion of the clinician
•5. The PROSE design does NOT include fenestrations
•6. Subject requires PROSE devices to treat symptoms and/or signs from underlying dry eye disease, GVHD, Sjogren's syndrome, limbal stem cell deficiency, keratoconjunctivitis sicca, or ocular surface disease
•7. Baseline Corneal staining grade of 2 or higher in total, both eyes combined (NEI Grading System)
•8. Baseline Ocular Surface Disease Index 13 or greater
•9. In the opinion of the investigator, the subject can follow study instructions
•10. In the opinion of the investigator, the subject can complete all study procedures and visits
+4 more criteria

Exclusion Criteria

•1. Is currently participating in any other type of eye-related clinical or research study
•2. Is pregnant or nursing as reported by the subject.
•3. Has a condition or is in a situation which, in the investigator's opinion, may put the subject at significant risk, may confound study outcomes, or may significantly interfere with the subject's participation in the study.
•4. Has had previous ocular surgery within the past 12 weeks.
•5. Currently uses or has a prior history of using Restasis in the last 3 months
•6. Currently uses or has a prior history of using Cequa in the last 3 months
•7. Is currently using Xiidra and has been using Xiidra for less than 3 months
•8. Has a history of an allergic reaction or hypersensitivity to any active or inactive ingredient found in Restasis or Cequa or Purilens.
•9. Is wearing a PROSE device with Tangible HydraPEG coating
•10. The subject is not wearing their PROSE devices daily
+9 more criteria

Locations (1)

BostonSight

Needham, Massachusetts, United States

Key Dates

Start Date

May 1, 2021

Primary Completion Date

September 1, 2021

Completion Date

September 1, 2021

Last Updated

April 19, 2023

Conditions

Ocular Surface Disease

Interventions

cyclosporine ophthalmic emulsion 0.05%

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 19, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Novel Use of Restasis and PROSE Devices

Inclusion Criteria

Exclusion Criteria

Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical Medications

Clinical Application Research of Scleral Lenses in Ocular Surface Diseases

The Effects of Androgen Replacement Therapy on Tear Osmolarity and Ocular Surface Parameters in Androgen Deficiency

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Ocular Surface Disease and IOP Monitoring With Travoprost Without Conservatives

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