Ocular Surface DiseasePhase 3NCT04735510
Novel Use of Restasis and PROSE Devices
A Phase 3 study testing cyclosporine ophthalmic emulsion 0.05% in people with Ocular Surface Disease, run by Boston Sight at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ocular Surface Disease
- What is being tested?
- cyclosporine ophthalmic emulsion 0.05%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2021to Sep 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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.
- -
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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).
- Conditions
- Ocular Surface Disease
- Being tested
- cyclosporine ophthalmic emulsion 0.05%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclosporine ophthalmic emulsion 0.05%Drug
All subjects will receive restasis
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | This is a single arm study in which all subjects will receive study medication. Receives: Drug: cyclosporine ophthalmic emulsion 0.05% |
What is being measured
The primary outcome is the main question the study is designed to answer.
subjective responses regarding symptoms
Subjects will be given a baseline tolerability questionnaire Disease Index (OSDI)
Measured: Baseline
subjective responses regarding symptoms
Subjects will be given a baseline tolerability questionnaire Disease Index (OSDI)
Measured: 1 week
subjective responses regarding symptoms
Subjects will be given a baseline tolerability questionnaire Disease Index (OSDI)
Measured: 1 month
Secondary outcomes (3)
Oculus keratograph scan
A scan of the eye surface will classify eye redness
Measured: Baseline
Oculus keratograph scan
A scan of the eye surface will classify eye redness
Measured: 1 week
Oculus keratograph scan
A scan of the eye surface will classify eye redness
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study startMay 2021 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Why it stopped: study redesigned
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular Surface DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive study drug
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Sight
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel C Brocks, Boston Sight
- Investigators
- Daniel Brocks, MD, Principal investigator, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735510
- Sponsor's protocol ID
- BFS-RGN-01
- Status last verified
- Apr 2023
- First submitted
- 25 Jan 2021
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04735510
- Acronym / sponsor ID
- BFS-RGN-01
- Conditions
- Ocular Surface Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study redesigned
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston SightUniversity, hospital or other
- Study start
- May 2021 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 3 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive study drug
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Drug: cyclosporine ophthalmic emulsion 0.05%This is a single arm study in which all subjects will receive study medication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cyclosporine ophthalmic emulsion 0.05%All subjects will receive restasis | Drug | Single arm |
Primary outcome
subjective responses regarding symptoms
Time frame: Baseline
Subjects will be given a baseline tolerability questionnaire Disease Index (OSDI)
subjective responses regarding symptoms
Time frame: 1 week
Subjects will be given a baseline tolerability questionnaire Disease Index (OSDI)
subjective responses regarding symptoms
Time frame: 1 month
Subjects will be given a baseline tolerability questionnaire Disease Index (OSDI)
3 secondary outcomes
Oculus keratograph scan
Time frame: Baseline
Oculus keratograph scan
Time frame: 1 week
Oculus keratograph scan
Time frame: 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Individual participant dataSharing planned: No. There is no plan to share IPD
Related trials for Ocular Surface Disease
Not yet recruiting
LacriFill Canalicular Occlusion for Dry Eye After LASIK
Dry Eye Syndrome
Not yet recruiting
TearCare in Young Adults
Meibomian Gland Dysfunction (Disorder)
Not yet recruitingPhase 1
A Clinical Study to Evaluate the Safety and Effectiveness of MSCohi-O Lens in the Treatment of Immune-related Ocular Surface Diseases.
Keratitis, Autoimmunity
RecruitingPhase 2
Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
Persistent Corneal Epithelial Defect, Corneal Epithelial Disorders
RecruitingObservational study
Early Risk Stratification of Thyroid Eye Disease in Newly Diagnosed Graves' Disease
Graves' Orbitopathy, Thyroid Eye Disease, TED
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Brocks, MD principal investigator
Chief Medical Officer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cyclosporine ophthalmic emulsion 0.05% in people with Ocular Surface Disease, run by Boston Sight at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
subjective responses regarding symptoms (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.