Novel Use of Restasis and PROSE Devices
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Single arm This is a single arm study in which all subjects will receive study medication. |
Drug: cyclosporine ophthalmic emulsion 0.05%
All subjects will receive restasis
|
Outcome Measures
Primary Outcome Measures
- subjective responses regarding symptoms [Baseline]
Subjects will be given a baseline tolerability questionnaire Disease Index (OSDI)
- subjective responses regarding symptoms [1 week]
Subjects will be given a baseline tolerability questionnaire Disease Index (OSDI)
- subjective responses regarding symptoms [1 month]
Subjects will be given a baseline tolerability questionnaire Disease Index (OSDI)
Secondary Outcome Measures
- Oculus keratograph scan [Baseline]
A scan of the eye surface will classify eye redness
- Oculus keratograph scan [1 week]
A scan of the eye surface will classify eye redness
- Oculus keratograph scan [1 month]
A scan of the eye surface will classify eye redness
Other Outcome Measures
- Slit lamp exam [Baseline]
The PI will perform a slit lamp exam and staining to measure conjunctival redness
- Slit lamp exam [1 week]
The PI will perform a slit lamp exam and staining to measure conjunctival redness
- Slit lamp exam [1 month]
The PI will perform a slit lamp exam and staining to measure conjunctival redness
- Corneal Staining [baseline]
The PI will perform a slit lamp exam and staining to measure corneal staining
- Corneal Staining [1 week]
The PI will perform a slit lamp exam and staining to measure corneal staining
- Corneal staining [1 month]
The PI will perform a slit lamp exam and staining to measure corneal staining
Eligibility Criteria
Criteria
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)
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | BostonSight | Needham | Massachusetts | United States | 02494 |
Sponsors and Collaborators
- Boston Sight
Investigators
- Principal Investigator: Daniel Brocks, MD, Chief Medical Officer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BFS-RGN-01