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

Ocular Surface Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04918823
• Other study ID #: BFS-REGEN-01
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 15, 2021
• Est. completion date: April 14, 2023

Study information

• Verified date: April 2023
• Source: Boston Sight
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 14, 2023
• Est. primary completion date: April 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ocular Surface Disease

Intervention

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

Locations

Country	Name	City	State
United States	BostonSight	Needham	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Sight	Allergan

Country where clinical trial is conducted

United States, 

Outcome

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