Trial Outcomes & Findings for Trial of Netarsudil for Prevention of Corticosteroid-induced Intraocular Pressure Elevation (NCT NCT03248037)

Results Overview

Intraocular pressure measurement exceeding 24 mm Hg or more than 10 mm Hg greater than the pre-randomization reading.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

120 participants

Primary outcome timeframe

from date of randomization until the date of first documented intraocular pressure elevation exceeding defined threshold up to 9 months

Results posted on

2021-02-12

Participant Flow

As specified in the protocol, a total of 120 unique participants were enrolled in the study; 71 enrolled both eyes in the study and the fellow eyes were automatically assigned to opposite treatment arms, so 71 subjects participated in both treatment arms.

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	Netarsudil Netarsudil ophthalmic solution 0.02%, dosed topically once a day for 9 months Netarsudil: netarsudil opthalmic solution 0.02%	Placebo Placebo eye drop, dosed topically once a day for 9 months Placebo: Placebo eye drops
Overall Study STARTED	95 95	96 96
Overall Study COMPLETED	74 74	87 87
Overall Study NOT COMPLETED	21 21	9 9

Reasons for withdrawal

Reasons for withdrawal
Measure	Netarsudil Netarsudil ophthalmic solution 0.02%, dosed topically once a day for 9 months Netarsudil: netarsudil opthalmic solution 0.02%	Placebo Placebo eye drop, dosed topically once a day for 9 months Placebo: Placebo eye drops
Overall Study Withdrawal by Subject	6	9
Overall Study Adverse Event	15	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Netarsudil n=95 Participants Netarsudil ophthalmic solution 0.02%, dosed topically once a day for 9 months Netarsudil: netarsudil opthalmic solution 0.02%	Placebo n=96 Participants Placebo eye drop, dosed topically once a day for 9 months Placebo: Placebo eye drops	Total n=191 Participants Total of all reporting groups
Age, Continuous	68 years n=95 Participants	67 years n=96 Participants	67 years n=191 Participants
Sex: Female, Male Female	54 Participants n=95 Participants	61 Participants n=96 Participants	115 Participants n=191 Participants
Sex: Female, Male Male	41 Participants n=95 Participants	35 Participants n=96 Participants	76 Participants n=191 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	95 Participants n=95 Participants	96 Participants n=96 Participants	191 Participants n=191 Participants

PRIMARY outcome

Timeframe: from date of randomization until the date of first documented intraocular pressure elevation exceeding defined threshold up to 9 months

Intraocular pressure measurement exceeding 24 mm Hg or more than 10 mm Hg greater than the pre-randomization reading.

Outcome measures

Outcome measures
Measure	Netarsudil n=95 Participants Netarsudil ophthalmic solution 0.02%, dosed topically once a day for 9 months Netarsudil: netarsudil opthalmic solution 0.02%	Placebo n=96 Participants Placebo eye drop, dosed topically once a day for 9 months Placebo: Placebo eye drops
Intraocular Pressure	11 Participants	18 Participants

Adverse Events

Netarsudil

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Netarsudil n=95 participants at risk Netarsudil ophthalmic solution 0.02%, dosed topically once a day for 9 months Netarsudil: netarsudil opthalmic solution 0.02%	Placebo n=96 participants at risk Placebo eye drop, dosed topically once a day for 9 months Placebo: Placebo eye drops
Eye disorders Air re-injection	21.1% 20/95 • Number of events 20 • 9 months	18.8% 18/96 • Number of events 18 • 9 months
Eye disorders Ocular irritation considered related to study drug use	23.2% 22/95 • Number of events 22 • 9 months	0.00% 0/96 • 9 months

Additional Information

Marianne Price

Cornea Research Foundation of America

Phone: 3178142990

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place