Trial Outcomes & Findings for Management of Signs and Symptoms Associated With Dry Eye Disease (NCT NCT04015219)

Last Updated: 2022-12-23

Results Overview

corneal fluorescein staining score of study eye graded from 0 to 9, with a score of 9 being worse. The corneal fluorescein staining score is the sum of three scores by subdividing the entire cornea into upper 1/3, middle 1/3, and lower 1/3, of which each is graded from 0 (no staining) to 3 (diffuse staining).

Recruitment status

TERMINATED

Study phase

Target enrollment

3 participants

Primary outcome timeframe

1 month

Results posted on

2022-12-23

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Arm PROKERA SLIM + Standard of Care PROKERA SLIM is a self retained cryopreserved amniotic membrane that is inserted once for 5 ±1 days	Control Arm Standard of Care lifitegrast ophthalmic solution: Xiidra® (5% lifitegrast ophthalmic solution, Shire, Lexington, MA)
Overall Study STARTED	2	1
Overall Study COMPLETED	2	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Management of Signs and Symptoms Associated With Dry Eye Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Arm n=2 Participants PROKERA SLIM + Standard of Care Self retained cryopreserved amniotic membrane: PROKERA SLIM lifitegrast ophthalmic solution: Xiidra® (5% lifitegrast ophthalmic solution, Shire, Lexington, MA)	Control Arm n=1 Participants Standard of Care lifitegrast ophthalmic solution: Xiidra® (5% lifitegrast ophthalmic solution, Shire, Lexington, MA)	Total n=3 Participants Total of all reporting groups
Age, Continuous	72 years STANDARD_DEVIATION 4.2 • n=5 Participants	46 years STANDARD_DEVIATION 0 • n=7 Participants	63 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Outcome measures

Outcome measures
Measure	Treatment Arm n=2 Participants PROKERA SLIM + Standard of Care Self retained cryopreserved amniotic membrane: PROKERA SLIM lifitegrast ophthalmic solution: Xiidra® (5% lifitegrast ophthalmic solution, Shire, Lexington, MA)	Control Arm n=1 Participants Standard of Care lifitegrast ophthalmic solution: Xiidra® (5% lifitegrast ophthalmic solution, Shire, Lexington, MA)
Corneal Fluorescein Staining	0.5 units on a scale Standard Deviation 0.7	3 units on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: 1 month

Patient subjectively evaluates eye dryness score using a visual analog scale from 0 to 100 maximal discomfort

Outcome measures

Outcome measures
Measure	Treatment Arm n=2 Participants PROKERA SLIM + Standard of Care Self retained cryopreserved amniotic membrane: PROKERA SLIM lifitegrast ophthalmic solution: Xiidra® (5% lifitegrast ophthalmic solution, Shire, Lexington, MA)	Control Arm n=1 Participants Standard of Care lifitegrast ophthalmic solution: Xiidra® (5% lifitegrast ophthalmic solution, Shire, Lexington, MA)
Eye Dryness Score	57.5 units on a scale Standard Deviation 46	75 units on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: 1 month

Patient subjectively evaluates OSDI questionnaire, OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability

Outcome measures

Outcome measures
Measure	Treatment Arm n=2 Participants PROKERA SLIM + Standard of Care Self retained cryopreserved amniotic membrane: PROKERA SLIM lifitegrast ophthalmic solution: Xiidra® (5% lifitegrast ophthalmic solution, Shire, Lexington, MA)	Control Arm n=1 Participants Standard of Care lifitegrast ophthalmic solution: Xiidra® (5% lifitegrast ophthalmic solution, Shire, Lexington, MA)
Ocular Surface Disease Index (OSDI)	64.5 units on a scale Standard Deviation 35	52 units on a scale Standard Deviation 0

Adverse Events

Treatment Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Medical Affairs

BioTissue

Phone: 8882968858

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place