Trial Outcomes & Findings for Trial of Netarsudil for Acceleration of Corneal Endothelial Restoration (NCT NCT03971357)

Results Overview

The outcome measure was the percentage area of the cornea that remained edematous after removal of the endothelium. At the time of surgery, the surgeon recorded the lengths of the major and minor axes of the approximately circular area of endothelium removal; these values were used to calculate the area of stripping. At each postoperative exam, the examiner recorded the lengths of the major and minor axes of the edematous area; these values were used to calculate the area of edema. The percentage that remained edematous at 5 weeks was calculated by dividing the area of edema at 5 weeks by the area stripped.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

19 participants

Primary outcome timeframe

5 weeks

Results posted on

2023-02-06

Participant Flow

Participant milestones

Participant milestones
Measure	Netarsudil Netarsudil ophthalmic solution 0.02%, dosed topically daily for the 3-month study duration or until 2 weeks after corneal clearing is complete, whichever occurs sooner Netarsudil: netarsudil opthalmic solution 0.02%	Placebo Placebo eye drop, dosed topically daily for the 3-month study duration or until 2 weeks after corneal clearing is complete, whichever occurs sooner. Placebo: Placebo eye drops
Overall Study STARTED	10	9
Overall Study COMPLETED	10	8
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Netarsudil Netarsudil ophthalmic solution 0.02%, dosed topically daily for the 3-month study duration or until 2 weeks after corneal clearing is complete, whichever occurs sooner Netarsudil: netarsudil opthalmic solution 0.02%	Placebo Placebo eye drop, dosed topically daily for the 3-month study duration or until 2 weeks after corneal clearing is complete, whichever occurs sooner. Placebo: Placebo eye drops
Overall Study Lack of Efficacy	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Netarsudil n=10 Participants Netarsudil ophthalmic solution 0.02%, dosed topically daily for the 3-month study duration or until 2 weeks after corneal clearing is complete, whichever occurs sooner Netarsudil: netarsudil opthalmic solution 0.02%	Placebo n=9 Participants Placebo eye drop, dosed topically daily for the 3-month study duration or until 2 weeks after corneal clearing is complete, whichever occurs sooner. Placebo: Placebo eye drops	Total n=19 Participants Total of all reporting groups
Age, Continuous	65 years STANDARD_DEVIATION 10 • n=10 Participants	58 years STANDARD_DEVIATION 17 • n=9 Participants	62 years STANDARD_DEVIATION 14 • n=19 Participants
Sex: Female, Male Female	10 Participants n=10 Participants	8 Participants n=9 Participants	18 Participants n=19 Participants
Sex: Female, Male Male	0 Participants n=10 Participants	1 Participants n=9 Participants	1 Participants n=19 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	10 participants n=10 Participants	9 participants n=9 Participants	19 participants n=19 Participants

PRIMARY outcome

Timeframe: 5 weeks

The outcome measure was the percentage area of the cornea that remained edematous after removal of the endothelium. At the time of surgery, the surgeon recorded the lengths of the major and minor axes of the approximately circular area of endothelium removal; these values were used to calculate the area of stripping. At each postoperative exam, the examiner recorded the lengths of the major and minor axes of the edematous area; these values were used to calculate the area of edema. The percentage that remained edematous at 5 weeks was calculated by dividing the area of edema at 5 weeks by the area stripped.

Outcome measures

Outcome measures
Measure	Netarsudil n=10 Participants Netarsudil ophthalmic solution 0.02%, dosed topically daily for the 3-month study duration or until 2 weeks after corneal clearing is complete, whichever occurs sooner Netarsudil: netarsudil opthalmic solution 0.02%	Placebo n=9 Participants Placebo eye drop, dosed topically daily for the 3-month study duration or until 2 weeks after corneal clearing is complete, whichever occurs sooner. Placebo: Placebo eye drops
Corneal Clearing After Endothelial Removal for Treatment of Fuchs Dystrophy	42 percentage of area stripped Standard Deviation 45	43 percentage of area stripped Standard Deviation 49

Adverse Events

Netarsudil

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Netarsudil n=10 participants at risk Netarsudil ophthalmic solution 0.02%, dosed topically daily for the 3-month study duration or until 2 weeks after corneal clearing is complete, whichever occurs sooner Netarsudil: netarsudil opthalmic solution 0.02%	Placebo n=9 participants at risk Placebo eye drop, dosed topically daily for the 3-month study duration or until 2 weeks after corneal clearing is complete, whichever occurs sooner. Placebo: Placebo eye drops
Eye disorders cystoid macular edema	10.0% 1/10 • Number of events 1 • 3 months	0.00% 0/9 • 3 months
Eye disorders microcystic corneal epithelial bullae	10.0% 1/10 • Number of events 1 • 3 months	0.00% 0/9 • 3 months
Eye disorders eye discomfort	20.0% 2/10 • Number of events 2 • 3 months	33.3% 3/9 • Number of events 3 • 3 months

Additional Information

Marianne Price

Price Vision Group

Phone: 317-814-2990

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place