Eye Disease, Glaucoma, Ocular Hypertension
Conditions
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.
Interventions
DRUGAMA0076
DRUGPlacebo
Sponsors
Amakem, NV
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
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline in mean diurnal intraocular pressure | 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed