Ocular Hypotensive Efficacy of AR-102

A Phase II, First-in-human Dose-escalation, Double-masked, Randomized, Vehicle-controlled, Dose-response Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-102 in Subjects With Elevated Intraocular Pressure

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00523250

Enrollment

Registered

2007-08-31

Start date

2007-09-30

Completion date

2008-03-31

Last updated

2014-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

Keywords

Glaucoma

Brief summary

A double-masked, randomized, vehicle-controlled, dose-response study assessing the safety and ocular hypotensive efficacy of AR-102 in subjects with elevated intraocular pressure. The Null hypothesis is that the ocular hypotensive efficacy of each dose of AR-102 Ophthalmic Solution will not be different from that of its vehicle.

Detailed description

A double-masked, randomized, vehicle-controlled, dose-response study assessing the safety and ocular hypotensive efficacy of AR-102 in subjects with elevated intraocular pressure.

Interventions

DRUGAR-102 0.003% Ophthalmic Solution

DRUGAR-102 0.005% Ophthalmic Solution

DRUGAR-102 0.01% Ophthalmic Solution

DRUGAR-102 0.03% Ophthalmic Solution

DRUGAR-102 Vehicle Ophthalmic Solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 18 years of age or greater (male, or female not of childbearing potential). * Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT) in the study eye(s). * Corrected visual acuity by ETDRS in each eye of +1.0 logMAR units or better

Exclusion criteria

* Known hypersensitivity to any component of the formulation or to topical anesthetics * Previous glaucoma intraocular surgery or laser procedures in study eye(s) * Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, cardiovascular or endocrine disorders) which might interfere with the study. * Participation in any study involving an investigational drug within the past 30 days.

Design outcomes

Primary

Measure	Time frame
The primary efficacy endpoint will be mean change from baseline in intraocular pressure at each time point.	One week

Secondary

Measure	Time frame
The primary safety endpoints will be visual acuity, objective biomicroscopic and ophthalmoscopic examination, and subjective comfort as measured by adverse events in response to subject questionnaires	One week

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026