Multiple Dose-parallel-group Study of AMA0076 in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension

Amakem

Status and phase: Completed; Phase 2

Conditions: Glaucoma; Ocular Hypertension; Eye Disease

Treatments: Drug: Placebo; Drug: AMA0076

Study type: Interventional

Funder types: Industry

Identifiers

NCT02136940

AMA0076-S-202

Details and patient eligibility

About

The objective of this parallel group study is to evaluate the safety, tolerability and efficacy of AMA0076 in reduction of intraocular pressure in subjects with primary open-angle glaucoma or ocular hypertension.

Enrollment: 103 patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults 30-85 years of age.
• Diagnosis of either POAG or OHT in both eyes.
• Not receiving medication for IOP, or able to stop such medication for a washout period and the duration of the study without significant risk of adverse consequences related to glaucomatous disease.
• Elevated IOP (≥ 24 and ≤ 33 mm Hg at 8 AM and ≥ 21 and ≤ 33 mm Hg at 10 AM on Screening Two visit and Baseline visit in one or both eyes off treatment [after a washout phase in those subjects who were receiving ocular hypotensive therapy]).

Exclusion criteria

Ophthalmic exclusion criteria:

• Uncontrolled intraocular hypertension defined as > 33 mm Hg in either eye at either of the screening/baseline visits (after a washout phase in those subjects who were currently receiving ocular hypotensive therapy).
• Receiving more than one medication for IOP in either eye at time of screening.
• Abnormal central corneal thickness.
• BCVA worse than 20/200 (logMAR 1.0) in either eye
• Significant visual field loss.
• Acute angle-closure glaucoma or appositional or very narrow anterior chamber angle in either eye.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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103 participants in 4 patient groups, including a placebo group

AMA0076 0.1%

Experimental group

Description:

Eligible subjects who meet the inclusion/exclusion criteria will be randomized to active or placebo (vehicle) in a 1:1:1:1 allocation ratio.

Treatment:

Drug: AMA0076

AMA0076 0.25%

Experimental group

Description:

Eligible subjects who meet the inclusion/exclusion criteria will be randomized to active or placebo (vehicle) in a 1:1:1:1 allocation ratio.

Treatment:

Drug: AMA0076

AMA0076 0.50%

Experimental group

Description:

Eligible subjects who meet the inclusion/exclusion criteria will be randomized to active or placebo (vehicle) in a 1:1:1:1 allocation ratio.

Treatment:

Drug: AMA0076

Placebo

Placebo Comparator group

Description:

Eligible subjects who meet the inclusion/exclusion criteria will be randomized to active or placebo (vehicle) in a 1:1:1:1 allocation ratio.

Treatment:

Drug: Placebo