Novel Use of Restasis and PROSE Devices

Phase 3

Withdrawn

• Conditions: Ocular Surface Disease
• Interventions: Drug: cyclosporine ophthalmic emulsion 0.05%

• Registration Number: NCT04735510
• Lead Sponsor: Boston Sight

Brief 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).

Study Timeline

• Study First Submitted: 2021-01-25
• Study First Submitted QC: 2021-01-28
• Study First Posted: 2021-02-03
• Study Start: 2021-05
• Primary Completion: 2021-09
• Study Completion: 2021-09
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-18
• Last Update Posted: 2023-04-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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
11. Able to wear PROSE device continuously for at least 6 hours at a time without removal, in each eye
12. Able to wear PROSE device for at least 10 total hours a day, in each eye
13. Able to wear PROSE device in subsequent continuous sessions of 6 hours, followed by a break to re-instill Restasis in device bowl, followed by another period of continuous wear of at least 4 hours
14. Currently using buffered preservative free normal saline (Purilens) in the device bowl or willing to transition to buffered preservative free normal saline (Purilens) use in the device bowl during the study

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

11. The subject is only wearing a device for one eye.

12. The participant is monocular

13. The subject wears a PROSE lens with fenestrations

14. The participant carries a diagnosis of glaucoma or ocular hypertension or glaucoma suspect AND is currently using glaucoma medications

15. The participant is NOT able to wear PROSE devices for 6 hours continuously, followed by a break to re-instill Restasis, followed by an additional period of at least 4 hours of continuous wear

16. Allergy to sodium fluorescein

17. Allergy to lissamine green

18. Allergy or intolerance to Purilens solution.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	cyclosporine ophthalmic emulsion 0.05%	This is a single arm study in which all subjects will receive study medication.

Primary Outcome Measures

Name	Time	Method
subjective responses regarding symptoms	1 month	Subjects will be given a baseline tolerability questionnaire Disease Index (OSDI)

Secondary Outcome Measures

Name	Time	Method
Oculus keratograph scan	1 month	A scan of the eye surface will classify eye redness

Trial Locations

Locations (1)

BostonSight; 🇺🇸 Needham, Massachusetts, United States