Multiple Dose-escalation Study of AMA0076 in Patients With Ocular Hypertension or Primary Open-angle Glaucoma

A Phase 2a, Randomized, Double-masked, Placebo-controlled, Dose-escalation Study of AMA0076 in Topical Ocular Formulation for Safety, Tolerability and Efficacy in Reduction of Intraocular Pressure in Subjects With Ocular Hypertension or Primary Open-angle Glaucoma

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01693315

Enrollment

Registered

2012-09-26

Start date

2012-09-30

Completion date

2013-07-31

Last updated

2013-07-17

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

Conditions

Eye Disease, Glaucoma, Ocular Hypertension

Brief summary

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

Interventions

DRUGAMA0076

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 85 Years

Healthy volunteers

Inclusion criteria

include: 1. Adults 30-85 years of age 2. Diagnosis of either ocular hypertension or primary open-angle glaucoma in both eyes 3. 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 4. Elevated IOP (≥ 24 and ≤ 34 mm Hg at 8 AM and ≥ 21 and ≤ 34 mm Hg at 10 AM on Screening Two visit and Baseline visit in one or both eyes off treatment

Exclusion criteria

include: 1. Uncontrolled intraocular hypertension defined as \>34 mm Hg at either of the screening/baseline visits (after a washout phase in those subjects who were currently receiving ocular hypotensive therapy). 2. Receiving more than one medication for IOP at time of screening. 3. Central corneal thickness of less than 500 µm or greater than 620 µm. 4. BCVA worse than 20/200 in either eye 5. Significant visual field loss (ie, mean deviation \> 10 db or field loss within 10 degrees of fixation), a new field defect, or progression of an existing field defect in either eye during the year preceding the study. 6. Acute angle-closure glaucoma or appositional or very narrow anterior chamber angle in either eye.

Design outcomes

Primary

Measure	Time frame
intraocular pressure change from baseline.	4 weeks

Secondary

Measure	Time frame
Adverse events as a measure of safety/tolerability	4 weeks
IOP assessments at weekly visits	Weeks 1, 2, 3, 4

Countries

United States

Outcome results

None listed

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