Trial Outcomes & Findings for A Prospective Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Exfoliation Syndrome and Ocular Hypertension or Glaucoma (NCT NCT01936389)

Results Overview

Goldmann Aplanation Tonometry (IOP mmHg) will be used to measure the ocular hypotensive efficacy.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

6 months

Results posted on

2018-11-16

Participant Flow

Participant milestones

Participant milestones
Measure	0.5% 0.5% Rho-Kinase Inhibitor AR-12286	0.7% 0.7% Rho-Kinase Inhibitor AR-12286
Overall Study STARTED	5	5
Overall Study COMPLETED	4	5
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Prospective Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Exfoliation Syndrome and Ocular Hypertension or Glaucoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	0.5% n=5 Participants 0.5% Rho-Kinase Inhibitor AR-12286	0.7% n=5 Participants 0.7% Rho-Kinase Inhibitor AR-12286	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Age, Categorical >=65 years	3 Participants n=93 Participants	5 Participants n=4 Participants	8 Participants n=27 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Sex: Female, Male Male	3 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants

PRIMARY outcome

Timeframe: 6 months

Goldmann Aplanation Tonometry (IOP mmHg) will be used to measure the ocular hypotensive efficacy.

Outcome measures

Outcome measures
Measure	0.5% n=5 Participants 0.5% Rho-Kinase Inhibitor AR-12286	0.7% n=5 Participants 0.7% Rho-Kinase Inhibitor AR-12286
Evaluate the Ocular Hypotensive Efficacy of Rho Kinase Inhibitor (AR-12286 0.5% and 0.7%)	24.2 mmHg Standard Deviation 2.4	25.8 mmHg Standard Deviation 2.4

Adverse Events

0.5%

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

0.7%

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	0.5% n=5 participants at risk 0.5% Rho-Kinase Inhibitor AR-12286	0.7% n=5 participants at risk 0.7% Rho-Kinase Inhibitor AR-12286
Eye disorders Conjunctivitis	20.0% 1/5 • Number of events 1	0.00% 0/5

Additional Information

Jessica Jasien, MEn

NYGRI

Phone: 2124777540

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place