- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04735510
Novel Use of Restasis and PROSE Devices
April 18, 2023 updated by: Daniel C Brocks, Boston Sight
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
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).
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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 7.4 ) to better match the reported pH of RESTASIS (pH 6.5-8.05).
Study Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Needham, Massachusetts, United States, 02494
- BostonSight
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Allergy to sodium fluorescein
- Allergy to lissamine green
Allergy or intolerance to Purilens solution.
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Single arm
This is a single arm study in which all subjects will receive study medication.
|
All subjects will receive restasis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
subjective responses regarding symptoms
Time Frame: Baseline
|
Subjects will be given a baseline tolerability questionnaire Disease Index (OSDI)
|
Baseline
|
subjective responses regarding symptoms
Time Frame: 1 week
|
Subjects will be given a baseline tolerability questionnaire Disease Index (OSDI)
|
1 week
|
subjective responses regarding symptoms
Time Frame: 1 month
|
Subjects will be given a baseline tolerability questionnaire Disease Index (OSDI)
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oculus keratograph scan
Time Frame: Baseline
|
A scan of the eye surface will classify eye redness
|
Baseline
|
Oculus keratograph scan
Time Frame: 1 week
|
A scan of the eye surface will classify eye redness
|
1 week
|
Oculus keratograph scan
Time Frame: 1 month
|
A scan of the eye surface will classify eye redness
|
1 month
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Slit lamp exam
Time Frame: Baseline
|
The PI will perform a slit lamp exam and staining to measure conjunctival redness
|
Baseline
|
Slit lamp exam
Time Frame: 1 week
|
The PI will perform a slit lamp exam and staining to measure conjunctival redness
|
1 week
|
Slit lamp exam
Time Frame: 1 month
|
The PI will perform a slit lamp exam and staining to measure conjunctival redness
|
1 month
|
Corneal Staining
Time Frame: baseline
|
The PI will perform a slit lamp exam and staining to measure corneal staining
|
baseline
|
Corneal Staining
Time Frame: 1 week
|
The PI will perform a slit lamp exam and staining to measure corneal staining
|
1 week
|
Corneal staining
Time Frame: 1 month
|
The PI will perform a slit lamp exam and staining to measure corneal staining
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Daniel Brocks, MD, Chief Medical Officer
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 1, 2021
Primary Completion (Anticipated)
September 1, 2021
Study Completion (Anticipated)
September 1, 2021
Study Registration Dates
First Submitted
January 25, 2021
First Submitted That Met QC Criteria
January 28, 2021
First Posted (Actual)
February 3, 2021
Study Record Updates
Last Update Posted (Actual)
April 19, 2023
Last Update Submitted That Met QC Criteria
April 18, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BFS-RGN-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is no plan to share IPD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ocular Surface Disease
-
Benha UniversityCompletedOcular Surface DiseaseUnited Arab Emirates
-
Singapore National Eye CentreSingapore Eye Research InstituteSuspended
-
Boston SightAllerganCompletedOcular Surface DiseaseUnited States
-
Mahidol UniversityUnknownOcular Surface DiseaseThailand
-
NHS LanarkshireChief Scientist Office of the Scottish Government; NHS Research ScotlandCompleted
-
Seoul National University HospitalCompletedOcular Surface Disease
-
University of Applied Sciences and Arts Northwestern...CompletedOcular Surface Disease
-
Centre Hospitalier Universitaire de Saint EtienneSociété Française des Ophtalmologistes Adaptateurs de Lentilles de ContactUnknown
-
University of California, Los AngelesNovartisRecruitingGlaucoma | Ocular Surface DiseaseUnited States
-
Glia, LLCCompletedOcular Surface DiseaseUnited States
Clinical Trials on cyclosporine ophthalmic emulsion 0.05%
-
AllerganCompletedDry Eye SyndromesUnited States
-
Taejoon Pharmaceutical Co., Ltd.CompletedDry Eye | Dry Eye SyndromesKorea, Republic of
-
Aurinia Pharmaceuticals Inc.Completed
-
AllerganCompleted
-
AllerganCompleted
-
AllerganCompletedPterygiumSingapore, United States, Australia
-
AllerganCompletedKeratoconjunctivitis SiccaUnited States
-
AllerganCompletedDry Eye SyndromesUnited States
-
Baylor College of MedicineAllerganTerminatedDry EyeUnited States
-
AllerganCompletedArthritis, Rheumatoid | Lupus Erythematosus, Systemic | Scleroderma, Systemic | Keratoconjunctivitis Sicca | Sjogren's SyndromeUnited States