Clinical trial NCT02136940: Multiple Dose-parallel-group Study of AMA0076 in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
Official title: A Phase 2a, Multicenter, Randomized, Double-masked, Placebo-controlled, Parallel-group Study of AMA0076 in Topical Ocular Formulation for Safety, Tolerability and Efficacy in Reduction of Intraocular Pressure in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glaucoma
Ocular Hypertension
Eye Disease
Lead sponsor: Amakem, NV
Sponsor class: INDUSTRY
First posted: 2014-05-13
Enrollment: 103
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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean change from baseline in mean diurnal intraocular pressure
timeFrame: 4 weeks
Secondary outcomes:
measure: Mean, mean change and percent change from baseline in intraocular pressure in both mean diurnal intraocular pressure and intraocular pressure at equivalent diurnal time points.
timeFrame: 4 weeks
measure: Compare the safety and tolerability of topically administered AMA0076 compared to vehicle, by evaluation of safety variables
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Artesia
country: United States
facility: Artesia Clinical - Site 11
state: California
city: Inglewood
country: United States
facility: Inglewood Clinical Site - Site 15
state: California
city: Petaluma
country: United States
facility: Petaluma Clinical Site - Site 17
state: California
city: Morrow
country: United States
facility: Morrow Clinical Site - Site13
state: Georgia
city: Roswell
country: United States
facility: Roswell Clinical Site - Site 18
state: Georgia
city: Rochester
country: United States
facility: Rochester Clinical Site - Site 12
state: New York
city: Slingerlands
country: United States
facility: Slingerlands Clinical Site - Site 19
state: New York
city: Charlotte
country: United States
facility: Charlotte Clinical Site - Site 14
state: North Carolina
city: High Point
country: United States
facility: High Point Clinical Site - Site 16
state: North Carolina
Study officials:
References: