Novel Use of Cyclosporine Ophthalmic Emulsion 0.05% in a PROSE Device

NCT04918823 | Completed Phase 1 Results FDA Drug

• 1 other identifier: BFS-REGEN-01
• Study Type: interventional
• Target: 10
• 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). Secondary endpoints include early (1-month) efficacy data for ocular signs and symptoms.

Conditions

Ocular Surface Disease

Keywords

ocular surface disease; Restasis

Outcome Measures

Primary Outcomes (7)

• Ocular Surface Disease Index (OSDI) Score Change (1 Month Post Treatment Initiation)

  The Ocular Surface Disease Index (OSDI) is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease.

  1 month post initiation change in OSDI score

• Corneal Staining

  Corneal fluorescein staining, pre and post initiation of 0.05% cyclosporine treatment, is measured using the National Eye Institute (NEI) grading system. The NEI grading scale is a system for grading corneal fluorescein staining which divides the corneal surface into 5 areas \[central, superior, nasal, inferior, temporal\]. A standardized grading system of 0 to 3, with 0 being no staining (better outcome) and 3 being severe staining (worse outcome), is used for each of the areas of cornea. The scores from each corneal area are totaled to determine the total corneal staining score in each eye. The total corneal staining score has a minimum score of zero (better outcome) and a maximum score of 15 (worse outcome) for an individual eye.

  at baseline and at 1-month post treatment initiation

• Conjunctival Staining

  Conjunctival fluorescein staining, pre and post initiation of 0.05% cyclosporine treatment, is measured using the National Eye Institute (NEI) grading system. The NEI grading scale is a system for grading conjunctival fluorescein staining which divides the conjunctival surface into 6 areas. A standardized grading system of 0 to 3, with 0 being no staining (better outcome) and 3 being severe staining (worse outcome), is used for each of the areas of conjunctiva. The scores from each conjunctival area are totaled to determine the total conjunctival staining score in each eye. The total conjunctival staining score has a minimum score of zero (better outcome) and a maximum score of 18 (worse outcome) for an individual eye.

  baseline and 1-month post treatment initiation

• Visual Acuity

  Subjects vision was tested using Snellen visual acuity chart (converted to LogMAR scale) pre and post initiation of 0.05% cyclosporine treatment. The LogMAR scale ranges from +3.00 to -0.30. A Zero LogMAR indicates standard 20/20 vision. More negative logMAR scale vision indicates better vision. More positive logMAR scale vision indicates worse vision. Legal blindness is defined as a best-corrected visual acuity of +1.0 LogMAR pr worse in the better seeing eye.

  at baseline and 1-month post treatment initiation

• Conjunctival Redness

  The Efron Grading Scales for Contact Lens Complications includes a standardized method for quantifying the level of conjunctival redness noted on slit lamp examination. The scale ranges, in whole numbers, from 0 to 4, with 0 indicating that conjunctival redness is not present (better outcome) and 4 indicating that the most severe redness is present (worse outcome).

  baseline and one month post treatment initiation

• Tolerability Questionnaire Score

  Subjects completed questionnaires regarding PROSE device comfort and fit (Tolerability Questionnaire, scale 0 to 10, higher score means better outcome), measured pre and post initiation of 0.05% cyclosporine treatment. Total tolerability score is a composite score sum of SIX questions (maximum score of 60).

  baseline and one month post initiation treatment

• Automated Conjunctival Redness Without PROSE Device on the Eye

  Conjunctival redness score measured using the automated imaging system Keratograph 5M R-Scan. The Keratograph 5M R-scan is an imaging device which classifies bulbar and limbal conjunctival redness. The R-Scan detects blood vessels in the conjunctiva and evaluates the degree of redness. The minimum score per eye is 0 (no redness present, better outcome), while the maximum score per eye is 4 (most severe redness present, worse outcome).

  baseline and one month post treatment initiation

Study Arms (1)

Single arm

OTHER

All subjects will receive Restasis in this study

Drug: Restasis

Interventions

Restasis DRUG

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

Also known as: cyclosporine ophthalmic solution 0.05%

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) 7
• 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
• Allergan: collaborator

Study Sites (1)

BostonSight

Needham, Massachusetts, 02494, United States

Location

MeSH Terms

Interventions

Cyclosporins

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Daniel Brocks
• Organization: BostonSight

dbrocks@bostonsight.org

7817267337

Study Officials

• Daniel C Brocks, MD

  Boston Sight

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Medical Officer

Model Details: All subjects will receive study drug to be used in their device.

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 9, 2021
• Study Start: July 15, 2021
• Primary Completion: April 4, 2023
• Study Completion: April 14, 2023
• Last Updated: January 13, 2025
• Results First Posted: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)