Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2021-05-31
2021-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single arm
This is a single arm study in which all subjects will receive study medication.
cyclosporine ophthalmic emulsion 0.05%
All subjects will receive restasis
Interventions
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cyclosporine ophthalmic emulsion 0.05%
All subjects will receive restasis
Eligibility Criteria
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Inclusion Criteria
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)
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
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.
\-
18 Years
ALL
Yes
Sponsors
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Boston Sight
OTHER
Responsible Party
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Daniel C Brocks
Principal Investigator
Principal Investigators
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Daniel Brocks, MD
Role: PRINCIPAL_INVESTIGATOR
Chief Medical Officer
Locations
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BostonSight
Needham, Massachusetts, United States
Countries
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Other Identifiers
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BFS-RGN-01
Identifier Type: -
Identifier Source: org_study_id
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