Clinical trial NCT01693315: Multiple Dose-escalation Study of AMA0076 in Patients With Ocular Hypertension or Primary Open-angle Glaucoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glaucoma
Ocular Hypertension
Eye Disease
Lead sponsor: Amakem, NV
Sponsor class: INDUSTRY
First posted: 2012-09-26
Enrollment: 82
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: intraocular pressure change from baseline.
timeFrame: 4 weeks
Secondary outcomes:
measure: Adverse events as a measure of safety/tolerability
timeFrame: 4 weeks
measure: IOP assessments at weekly visits
timeFrame: Weeks 1, 2, 3, 4
Other outcomes:
Locations:
city: Artesia
country: United States
facility: Artesia Clinical Site - Site 02
state: California
city: Inglewood
country: United States
facility: Inglewood Clinical Site - Site 03
state: California
city: Petaluma
country: United States
facility: Petaluma Clinical Site - Site 05
state: California
city: New Haven
country: United States
facility: New Haven Clinical Site - Site 01
state: Connecticut
city: Atlanta
country: United States
facility: Atlanta Clinical Site - Site 04
state: Georgia
city: High Point
country: United States
facility: High Point Clinical Site - Site 06
state: North Carolina
Study officials:
References: