Multiple Dose-escalation Study of AMA0076 in Patients With Ocular Hypertension or Primary Open-angle Glaucoma

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01693315
• Other study ID #: AMA0076-201
• Status: Completed
• Phase: Phase 2
• First received: September 21, 2012
• Last updated: July 16, 2013
• Start date: September 2012
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/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 - Site 02	Artesia	California
United States	Atlanta Clinical Site - Site 04	Atlanta	Georgia
United States	High Point Clinical Site - Site 06	High Point	North Carolina
United States	Inglewood Clinical Site - Site 03	Inglewood	California
United States	New Haven Clinical Site - Site 01	New Haven	Connecticut
United States	Petaluma Clinical Site - Site 05	Petaluma	California

Sponsors (1)

Lead Sponsor	Collaborator
Amakem, NV

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intraocular pressure change from baseline.		4 weeks	No
Secondary	Adverse events as a measure of safety/tolerability		4 weeks	Yes
Secondary	IOP assessments at weekly visits		Weeks 1, 2, 3, 4	No