Novel Use of Restasis and PROSE Devices

NCT04735510 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: BFS-RGN-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Ocular Surface Disease

Outcome Measures

Primary Outcomes (3)

• subjective responses regarding symptoms

  Subjects will be given a baseline tolerability questionnaire Disease Index (OSDI)

  Baseline

• subjective responses regarding symptoms

  Subjects will be given a baseline tolerability questionnaire Disease Index (OSDI)

  1 week

• subjective responses regarding symptoms

  Subjects will be given a baseline tolerability questionnaire Disease Index (OSDI)

  1 month

Secondary Outcomes (3)

• Oculus keratograph scan

  Baseline

• Oculus keratograph scan

  1 week

• Oculus keratograph scan

  1 month

Other Outcomes (6)

• Slit lamp exam

  Baseline

• Slit lamp exam

  1 week

• Slit lamp exam

  1 month

Study Arms (1)

Single arm

OTHER

This is a single arm study in which all subjects will receive study medication.

Drug: cyclosporine ophthalmic emulsion 0.05%

Interventions

cyclosporine ophthalmic emulsion 0.05% DRUG

All subjects will receive restasis

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Sight: lead

Study Sites (1)

BostonSight

Needham, Massachusetts, 02494, United States

Location

Study Officials

• Daniel Brocks, MD

  Chief Medical Officer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All participants will receive study drug

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 3, 2021
• Study Start: May 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)