Clinical trial NCT04918823: Novel Use of Cyclosporine Ophthalmic Emulsion 0.05% in a PROSE Device
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Ocular Surface Disease
Keywords: ocular surface disease
Restasis
Lead sponsor: Boston Sight
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2021-06-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects will receive study drug to be used in their device.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Ocular Surface Disease Index (OSDI) Score Change (1 Month Post Treatment Initiation)
timeFrame: 1 month post initiation change in OSDI score
measure: Corneal Staining
timeFrame: at baseline and at 1-month post treatment initiation
measure: Conjunctival Staining
timeFrame: baseline and 1-month post treatment initiation
measure: Visual Acuity
timeFrame: at baseline and 1-month post treatment initiation
measure: Conjunctival Redness
timeFrame: baseline and one month post treatment initiation
measure: Tolerability Questionnaire Score
timeFrame: baseline and one month post initiation treatment
measure: Automated Conjunctival Redness Without PROSE Device on the Eye
timeFrame: baseline and one month post treatment initiation
Secondary outcomes:
Other outcomes:
Locations:
city: Needham
country: United States
facility: BostonSight
state: Massachusetts
Study officials:
affiliation: Boston Sight
name: Daniel C Brocks, MD
role: PRINCIPAL_INVESTIGATOR
References: