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

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02136940
• Other study ID #: AMA0076-S-202
• Status: Completed
• Phase: Phase 2
• First received: May 9, 2014
• Last updated: January 16, 2015
• Start date: April 2014
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Amakem, NV
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Eye Disease
• Eye Diseases
• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• AMA0076

• Placebo

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Amakem, NV

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in mean diurnal intraocular pressure		4 weeks	No
Secondary	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	No
Secondary	Compare the safety and tolerability of topically administered AMA0076 compared to vehicle, by evaluation of safety variables	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.	4 weeks	Yes