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Ocular Surface DiseasePhase 1/2NCT04918823

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

A Phase 1/2 study testing Restasis in people with Ocular Surface Disease, run by Boston Sight at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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?
Restasis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
15 Jul 2021to 14 Apr 2023
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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) 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

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 18Show 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.

United States1 site

  • BostonSight

    Needham, Massachusetts, 02494

Other trials in United States

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). Secondary endpoints include early (1-month) efficacy data for ocular signs and symptoms.

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 7.46 ) to better match the reported pH of RESTASIS (pH 6.5-8.05 ).

Outcomes will include subjective responses regarding the subject's symptoms and visual function in addition to the objective assessments of the health of the ocular surface seen on clinical examination. Results will be measured at baseline, after 1 week, and after 1 month of the study.

Being tested
Restasis
Keywords
ocular surface disease, Restasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RestasisDrug

    Also called cyclosporine ophthalmic solution 0.05%

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

Study groups in NCT04918823
Study groupRoleWhat they receive
Single armOtherAll subjects will receive Restasis in this study
Receives: Drug: Restasis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 month post initiation change in OSDI score

  2. 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.

    Measured: at baseline and at 1-month post treatment initiation

  3. 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.

    Measured: baseline and 1-month post treatment initiation

  4. 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.

    Measured: at baseline and 1-month post treatment initiation

  5. 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).

    Measured: baseline and one month post treatment initiation

  6. 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).

    Measured: baseline and one month post initiation treatment

  7. 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).

    Measured: baseline and one month post treatment initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2021
  2. Study start15 Jul 2021
  3. Primary completion4 Apr 2023
  4. Study completion14 Apr 2023

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
All subjects will receive study drug to be used in their device.
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04918823
Sponsor's protocol ID
BFS-REGEN-01
Status last verified
Jan 2025
First submitted
28 May 2021
Last updated
13 Jan 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: There is no IPD

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Restasis 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 18 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: finished, as of the sponsor's last update on 13 Jan 2025. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Ocular Surface Disease Index (OSDI) Score Change (1 Month Post Treatment Initiation) (time frame: 1 month post initiation change in OSDI score). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04918823.

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 13 Jan 2025.

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