Multiple Dose-parallel-group Study of AMA0076 in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
- Conditions
- Ocular HypertensionEye DiseaseGlaucoma
- Interventions
- Drug: Placebo
- Registration Number
- NCT02136940
- Lead Sponsor
- Amakem, NV
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 103
- 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]).
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AMA0076 0.25% AMA0076 Eligible subjects who meet the inclusion/exclusion criteria will be randomized to active or placebo (vehicle) in a 1:1:1:1 allocation ratio. AMA0076 0.50% AMA0076 Eligible subjects who meet the inclusion/exclusion criteria will be randomized to active or placebo (vehicle) in a 1:1:1:1 allocation ratio. AMA0076 0.1% AMA0076 Eligible subjects who meet the inclusion/exclusion criteria will be randomized to active or placebo (vehicle) in a 1:1:1:1 allocation ratio. Placebo Placebo Eligible subjects who meet the inclusion/exclusion criteria will be randomized to active or placebo (vehicle) in a 1:1:1:1 allocation ratio.
- Primary Outcome Measures
Name Time Method Mean change from baseline in mean diurnal intraocular pressure 4 weeks
- Secondary Outcome Measures
Name Time Method 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. 4 weeks Compare the safety and tolerability of topically administered AMA0076 compared to vehicle, by evaluation of safety variables 4 weeks Evaluation of safety variables including eye exam findings (best corrected visual acuity, biomicroscopy \[including grading of conjunctival hyperemia\], dilated fundus examination) adverse events, discontinuations due to adverse events, serious adverse events, and vital signs.
Trial Locations
- Locations (9)
Roswell Clinical Site - Site 18
🇺🇸Roswell, Georgia, United States
Petaluma Clinical Site - Site 17
🇺🇸Petaluma, California, United States
Rochester Clinical Site - Site 12
🇺🇸Rochester, New York, United States
Inglewood Clinical Site - Site 15
🇺🇸Inglewood, California, United States
Charlotte Clinical Site - Site 14
🇺🇸Charlotte, North Carolina, United States
Slingerlands Clinical Site - Site 19
🇺🇸Slingerlands, New York, United States
Artesia Clinical - Site 11
🇺🇸Artesia, California, United States
Morrow Clinical Site - Site13
🇺🇸Morrow, Georgia, United States
High Point Clinical Site - Site 16
🇺🇸High Point, North Carolina, United States