Novel Use of Cyclosporine Ophthalmic Emulsion 0.05% on Application of PROSE Devices for Management of Patients With Ocular Surface Disease

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

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.

Study Overview

• Status: Completed
• Conditions: Ocular Surface Disease
• Intervention / Treatment: Drug: Restasis

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Estelle Crowley; Phone Number: 781-726-7506; Email: ecrowley@bostonsight.org

Study Locations

• United States
  • Massachusetts
    • Needham, Massachusetts, United States, 02494
      • BostonSight

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single arm; All subjects will receive Restasis in this study	Drug: Restasis; Subject will use one drop of Restasis in the lens before insertion; Other Names: cyclosporine ophthalmic solution 0.05%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual function	subjects vision will be tested using snellen	Baseline
visual function	subjects vision will be tested using snellen	1 week
visual function	subjects vision will be tested using snellen	1 month
Subjects symptoms	subjects will complete questionnaires regarding device comfort and fit (Tolerability Questionnaire, scale 0 to 10, higher score means better outcome)	baseline
Subjects symptoms	subjects will complete questionnaires regarding device comfort and fit (Tolerability Questionnaire, scale 0 to 10, higher score means better outcome)	1 week
Subjects symptoms	subjects will complete questionnaires regarding device comfort and fit (Tolerability Questionnaire, scale 0 to 10, higher score means better outcome)	1 month

Collaborators and Investigators

• Sponsor: Boston Sight
• Collaborators: Allergan
• Investigators: Principal Investigator: Daniel C Brocks, MD, Boston Sight

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2021
• Primary Completion (Actual): April 4, 2023
• Study Completion (Actual): April 14, 2023

Study Registration Dates

• First Submitted: May 28, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (Actual): June 9, 2021

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: ocular surface disease; Restasis
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Antifungal Agents; Pharmaceutical Solutions; Calcineurin Inhibitors; Ophthalmic Solutions; Cyclosporine; Cyclosporins
• Other Study ID Numbers: BFS-REGEN-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes