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

Completed · Phase 2 · Has a placebo group

Conditions studied: Glaucoma, Ocular Hypertension, Eye Disease

In brief

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.

Key facts

Study ID

NCT02136940

Run by

Amakem, NV

People needed

103

Starts

2014-04-01

Expected to finish

2014-12-01

Last updated by the study team

2015-01-21

Who can join

Age: 30 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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]).

You may not qualify if…

• 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.

Where it is running

• Artesia Clinical - Site 11 — Artesia, California, United States
• Inglewood Clinical Site - Site 15 — Inglewood, California, United States
• Petaluma Clinical Site - Site 17 — Petaluma, California, United States
• Morrow Clinical Site - Site13 — Morrow, Georgia, United States
• Roswell Clinical Site - Site 18 — Roswell, Georgia, United States
• Rochester Clinical Site - Site 12 — Rochester, New York, United States
• Slingerlands Clinical Site - Site 19 — Slingerlands, New York, United States
• Charlotte Clinical Site - Site 14 — Charlotte, North Carolina, United States
• High Point Clinical Site - Site 16 — High Point, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.