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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Ocular Surface Disease

Intervention / Treatment
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* Drug: Restasis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written Informed Consent has been obtained prior to any study-related procedures taking place Subject is Male or Female, 18 years of age or older prior to the initial visit Is an established wearer of PROSE devices for > 6 months in both eyes Has a finalized PROSE lens design in both eyes, in the opinion of the clinician The PROSE design does NOT include fenestrations 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 Baseline Corneal staining grade of 2 or higher in total, both eyes combined (NEI Grading System) 7 Baseline Ocular Surface Disease Index 13 or greater In the opinion of the investigator, the subject can follow study instructions In the opinion of the investigator, the subject can complete all study procedures and visits Able to wear PROSE device continuously for at least 6 hours at a time without removal, in each eye Able to wear PROSE device for at least 10 total hours a day, in each eye 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 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: Is currently participating in any other type of eye-related clinical or research study Is pregnant or nursing as reported by the subject. 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. Has had previous ocular surgery within the past 12 weeks. Currently uses or has a prior history of using Restasis in the last 3 months Currently uses or has a prior history of using Cequa in the last 3 months Is currently using Xiidra and has been using Xiidra for less than 3 months Has a history of an allergic reaction or hypersensitivity to any active or inactive ingredient found in Restasis or Cequa or Purilens. Is wearing a PROSE device with Tangible HydraPEG coating The subject is not wearing their PROSE devices daily The subject is only wearing a device for one eye. The participant is monocular The subject wears a PROSE lens with fenestrations The participant carries a diagnosis of glaucoma or ocular hypertension or glaucoma suspect AND is currently using glaucoma medications 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 Allergy to sodium fluorescein Allergy to lissamine green Allergy or intolerance to Purilens solution.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All subjects will receive study drug to be used in their device.
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ocular surface disease, Restasis