Trial Outcomes & Findings for Novel Use of Cyclosporine Ophthalmic Emulsion 0.05% in a PROSE Device (NCT NCT04918823)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

10 participants

Primary outcome timeframe

1 month post initiation change in OSDI score

Results posted on

2025-01-13

Participant Flow

Participant milestones

Participant milestones
Measure	Single Arm All subjects will receive Restasis in this study Restasis: Subject will use one drop of Restasis in the lens before insertion
Overall Study STARTED	10
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm n=9 Participants All subjects will receive Restasis in this study Restasis: Subject will use one drop of Restasis in the lens before insertion
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	54.3 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants
Dry eye	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month post initiation change in OSDI score

Population: Subjects who completed the study

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.

Outcome measures

Outcome measures
Measure	Single Arm n=9 Participants All subjects will receive Restasis in this study Restasis: Subject will use one drop of Restasis in the lens before insertion
Ocular Surface Disease Index (OSDI) Score Change (1 Month Post Treatment Initiation)	-3.83 score on a scale Standard Error 6.87

PRIMARY outcome

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

Population: Subjects who completed the study

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.

Outcome measures

Outcome measures
Measure	Single Arm n=18 eyes All subjects will receive Restasis in this study Restasis: Subject will use one drop of Restasis in the lens before insertion
Corneal Staining Baseline corneal staining (NEI grading system)	11.89 score on a scale Standard Deviation 5.11
Corneal Staining 1-month post treatment initiation corneal staining (NEI grading system)	5.22 score on a scale Standard Deviation 4.49

PRIMARY outcome

Timeframe: baseline and 1-month post treatment initiation

Population: Subjects who completed the study

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.

Outcome measures

Outcome measures
Measure	Single Arm n=18 eyes All subjects will receive Restasis in this study Restasis: Subject will use one drop of Restasis in the lens before insertion
Conjunctival Staining Conjunctival staining (NEI grading system) at baseline	12.22 score on a scale Standard Deviation 10.49
Conjunctival Staining Conjunctival staining (NEI grading system) at 1-month post treatment initiation	7.11 score on a scale Standard Deviation 7.74

PRIMARY outcome

Timeframe: at baseline and 1-month post treatment initiation

Population: Subjects who completed the study

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.

Outcome measures

Outcome measures
Measure	Single Arm n=18 eyes All subjects will receive Restasis in this study Restasis: Subject will use one drop of Restasis in the lens before insertion
Visual Acuity BCVA baseline	0.359 score on a logMAR scale Standard Deviation 0.261
Visual Acuity BCVA final	0.353 score on a logMAR scale Standard Deviation 0.320

PRIMARY outcome

Timeframe: baseline and one month post treatment initiation

Population: All subjects who completed study

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).

Outcome measures

Outcome measures
Measure	Single Arm n=18 eyes All subjects will receive Restasis in this study Restasis: Subject will use one drop of Restasis in the lens before insertion
Conjunctival Redness Conjunctival redness (modified Efron scale) at baseline	16.78 score on a scale Standard Deviation 8.11
Conjunctival Redness Conjunctival redness (modified Efron scale) at 1 month post treatment initiation	10.2 score on a scale Standard Deviation 7.21

PRIMARY outcome

Timeframe: baseline and one month post initiation treatment

Population: Subjects who completed the study

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).

Outcome measures

Outcome measures
Measure	Single Arm n=9 Participants All subjects will receive Restasis in this study Restasis: Subject will use one drop of Restasis in the lens before insertion
Tolerability Questionnaire Score Total tolerability questionnaire score at baseline	46.22 tolerability score Standard Deviation 11.40
Tolerability Questionnaire Score Total tolerability questionnaire score 1 month post initiation of treatment	47.56 tolerability score Standard Deviation 11.22

PRIMARY outcome

Timeframe: 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

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).

Outcome measures

Outcome measures
Measure	Single Arm n=16 eyes All subjects will receive Restasis in this study Restasis: Subject will use one drop of Restasis in the lens before insertion
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
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 1.00

Adverse Events

Arm One

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm One n=10 participants at risk One subject withdrew from the study for ocular burning and stinging.
Eye disorders ocular burning and stinging	10.0% 1/10 • Number of events 1 • 1 month Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.

Other adverse events

Other adverse events
Measure	Arm One n=10 participants at risk One subject withdrew from the study for ocular burning and stinging.
Eye disorders ocular burning and stinging	10.0% 1/10 • Number of events 1 • 1 month Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.

Additional Information

Dr. Daniel Brocks

BostonSight

Phone: 7817267337

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place