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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04918823

Enrollment

Registered

2021-06-09

Start date

2021-07-15

Completion date

2023-04-14

Last updated

2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Surface Disease

Keywords

ocular surface disease, Restasis

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.

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.

Interventions

DRUGRestasis

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Written Informed Consent has been obtained prior to any study-related procedures taking place 2. Subject is Male or Female, 18 years of age or older prior to the initial visit 3. Is an established wearer of PROSE devices for \> 6 months in both eyes 4. Has a finalized PROSE lens design in both eyes, in the opinion of the clinician 5. The PROSE design does NOT include fenestrations 6. 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 7. Baseline Corneal staining grade of 2 or higher in total, both eyes combined (NEI Grading System) 7 8. Baseline Ocular Surface Disease Index 13 or greater 9. In the opinion of the investigator, the subject can follow study instructions 10. In the opinion of the investigator, the subject can complete all study procedures and visits 11. Able to wear PROSE device continuously for at least 6 hours at a time without removal, in each eye 12. Able to wear PROSE device for at least 10 total hours a day, in each eye 13. 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 14. 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

1. Is currently participating in any other type of eye-related clinical or research study 2. Is pregnant or nursing as reported by the subject. 3. 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. 4. Has had previous ocular surgery within the past 12 weeks. 5. Currently uses or has a prior history of using Restasis in the last 3 months 6. Currently uses or has a prior history of using Cequa in the last 3 months 7. Is currently using Xiidra and has been using Xiidra for less than 3 months 8. Has a history of an allergic reaction or hypersensitivity to any active or inactive ingredient found in Restasis or Cequa or Purilens. 9. Is wearing a PROSE device with Tangible HydraPEG coating 10. The subject is not wearing their PROSE devices daily 11. The subject is only wearing a device for one eye. 12. The participant is monocular 13. The subject wears a PROSE lens with fenestrations 14. The participant carries a diagnosis of glaucoma or ocular hypertension or glaucoma suspect AND is currently using glaucoma medications 15. 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 16. Allergy to sodium fluorescein 17. Allergy to lissamine green 18. Allergy or intolerance to Purilens solution.

Design outcomes

Primary

Measure	Time frame	Description
Ocular Surface Disease Index (OSDI) Score Change (1 Month Post Treatment Initiation)	1 month post initiation change in OSDI score	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.
Corneal Staining	at baseline and at 1-month post treatment initiation	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.
Conjunctival Staining	baseline and 1-month post treatment initiation	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.
Visual Acuity	at baseline and 1-month post treatment initiation	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.
Conjunctival Redness	baseline and one month post treatment initiation	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).
Tolerability Questionnaire Score	baseline and one month post initiation treatment	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).
Automated Conjunctival Redness Without PROSE Device on the Eye	baseline and one month post treatment initiation	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).

Countries

United States

Participant flow

Participants by arm

Arm	Count
Single Arm All subjects will receive Restasis in this study Restasis: Subject will use one drop of Restasis in the lens before insertion	9
Total	9

Baseline characteristics

Characteristic	Single Arm
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	2 Participants
Age, Categorical Between 18 and 65 years	7 Participants
Age, Continuous	54.3 years
Dry eye	9 participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants
Region of Enrollment United States	9 participants
Sex: Female, Male Female	4 Participants
Sex: Female, Male Male	5 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 10
other Total, other adverse events	1 / 10
serious Total, serious adverse events	1 / 10

Outcome results

Primary

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).

Time frame: baseline and one month post treatment initiation

Population: Sixteen of the eighteen study eyes (8 participants) had adequate K5MRS image acquisition for analysis. Image acquisition was not obtained (machine unable to acquire) for several conjunctival sections at several time points for one subject, so this subject was excluded from the K5MRS analysis

Arm	Measure	Group	Value (MEAN)	Dispersion
Single Arm	Automated Conjunctival Redness Without PROSE Device on the Eye	Conjunctival redness (K5MRS score) at baseline	3.74 score on a scale	Standard Deviation 1.09
Single Arm	Automated Conjunctival Redness Without PROSE Device on the Eye	Conjunctival redness (K5MRS score) 1 month post initiation of treatment	3.25 score on a scale	Standard Deviation 1

Primary

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).

Time frame: baseline and one month post treatment initiation

Population: All subjects who completed study

Arm	Measure	Group	Value (MEAN)	Dispersion
Single Arm	Conjunctival Redness	Conjunctival redness (modified Efron scale) at baseline	16.78 score on a scale	Standard Deviation 8.11
Single Arm	Conjunctival Redness	Conjunctival redness (modified Efron scale) at 1 month post treatment initiation	10.2 score on a scale	Standard Deviation 7.21

Primary

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.

Time frame: baseline and 1-month post treatment initiation