Trial Outcomes & Findings for Rhopressa for Corneal Edema Associated With Fuchs Dystrophy (NCT NCT04051463)

NCT ID: NCT04051463

Last Updated: 2021-10-19

Results Overview

Central corneal thickness at 1 month after randomization minus central corneal thickness at baseline

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 29 participants
• Primary outcome timeframe: 1 month
• Results posted on: 2021-10-19

Participant Flow

Participant milestones

Measure	Netarsudil A drop of Netarsudil 0.02% ophthalmic solution will be instilled into both eyes once daily at night. Netarsudil Ophthalmic Solution: Netarsudil eye drops instilled once daily	Placebo A placebo eye drop, consisting of the vehicle for netarsudil ophthalmic solution without the active ingredient, will be instilled into both eyes once daily at night. Placebo: Placebo eye drops instilled once daily
Overall Study STARTED	15	14
Overall Study COMPLETED	13	13
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rhopressa for Corneal Edema Associated With Fuchs Dystrophy

Baseline characteristics by cohort

Measure	Netarsudil n=15 Participants A drop of Netarsudil 0.02% ophthalmic solution will be instilled into both eyes once daily at night. Netarsudil Ophthalmic Solution: Netarsudil eye drops instilled once daily	Placebo n=14 Participants A placebo eye drop, consisting of the vehicle for netarsudil ophthalmic solution without the active ingredient, will be instilled into both eyes once daily at night. Placebo: Placebo eye drops instilled once daily	Total n=29 Participants Total of all reporting groups
Age, Continuous	68 years STANDARD_DEVIATION 5 • n=5 Participants	69 years STANDARD_DEVIATION 7 • n=7 Participants	68 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized White, non-Hispanic	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	14 participants n=7 Participants	29 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Central corneal thickness at 1 month after randomization minus central corneal thickness at baseline

Outcome measures

Measure	Netarsudil n=13 Participants A drop of Netarsudil 0.02% ophthalmic solution will be instilled into both eyes once daily at night. Netarsudil Ophthalmic Solution: Netarsudil eye drops instilled once daily	Placebo n=13 Participants A placebo eye drop, consisting of the vehicle for netarsudil ophthalmic solution without the active ingredient, will be instilled into both eyes once daily at night. Placebo: Placebo eye drops instilled once daily
Change in Central Corneal Thickness	-23 microns Interval -32.0 to -13.0	-2 microns Interval -9.0 to 5.0

SECONDARY outcome

Timeframe: 3 months

Change in CDVA (lines read on the eye chart at 3 months minus lines read at baseline)

Outcome measures

Measure	Netarsudil n=13 Participants A drop of Netarsudil 0.02% ophthalmic solution will be instilled into both eyes once daily at night. Netarsudil Ophthalmic Solution: Netarsudil eye drops instilled once daily	Placebo n=13 Participants A placebo eye drop, consisting of the vehicle for netarsudil ophthalmic solution without the active ingredient, will be instilled into both eyes once daily at night. Placebo: Placebo eye drops instilled once daily
Change in Corrected Distance Visual Acuity (CDVA)	1.9 lines on the eye chart Interval 0.8 to 3.0	0.3 lines on the eye chart Interval -0.7 to 1.3

Adverse Events

Netarsudil

Serious events: 0 serious events

Other events: 6 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

Measure	Netarsudil n=15 participants at risk A drop of Netarsudil 0.02% ophthalmic solution will be instilled into both eyes once daily at night. Netarsudil Ophthalmic Solution: Netarsudil eye drops instilled once daily	Placebo n=14 participants at risk A placebo eye drop, consisting of the vehicle for netarsudil ophthalmic solution without the active ingredient, will be instilled into both eyes once daily at night. Placebo: Placebo eye drops instilled once daily
Eye disorders conjunctival hyperemia	40.0% 6/15 • Number of events 6 • 3 months	21.4% 3/14 • Number of events 3 • 3 months
Eye disorders ocular irritation	13.3% 2/15 • Number of events 2 • 3 months	7.1% 1/14 • Number of events 1 • 3 months
Eye disorders glare	6.7% 1/15 • Number of events 1 • 3 months	0.00% 0/14 • 3 months
Eye disorders lacrimation	0.00% 0/15 • 3 months	7.1% 1/14 • Number of events 1 • 3 months

Additional Information

Marianne Price

Cornea Research Foundation of America

Phone: 317-814-2990

Email: mprice@cornea.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place