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

NCT ID: NCT04918823

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-15
• Study Completion Date: 2023-04-14

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). Secondary endpoints include early (1-month) efficacy data for ocular signs and symptoms.

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 7.46 ) to better match the reported pH of RESTASIS (pH 6.5-8.05 ).

Outcomes will include subjective responses regarding the subject's symptoms and visual function in addition to the objective assessments of the health of the ocular surface seen on clinical examination. Results will be measured at baseline, after 1 week, and after 1 month of the study.

Conditions

Ocular Surface Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single arm

All subjects will receive Restasis in this study

Group Type: OTHER

Restasis

Intervention Type: DRUG

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

Interventions

Restasis

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

Intervention Type: DRUG

Other Intervention Names

cyclosporine ophthalmic solution 0.05%

Eligibility Criteria

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) 7

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

Boston Sight

OTHER

Sponsor Role: lead

Responsible Party

Daniel C Brocks

Chief Medical Officer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel C Brocks, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Sight

Locations

BostonSight

Needham, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

BFS-REGEN-01

Identifier Type: -

Identifier Source: org_study_id