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

NCT02136940 | Completed Phase 2

• 1 other identifier: AMA0076-S-202
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 9

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.

Conditions

Glaucoma; Ocular Hypertension; Eye Disease

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in mean diurnal intraocular pressure

  4 weeks

Secondary Outcomes (2)

• 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

Study Arms (4)

AMA0076 0.1%

EXPERIMENTAL

Eligible subjects who meet the inclusion/exclusion criteria will be randomized to active or placebo (vehicle) in a 1:1:1:1 allocation ratio.

Drug: AMA0076

AMA0076 0.25%

EXPERIMENTAL

Eligible subjects who meet the inclusion/exclusion criteria will be randomized to active or placebo (vehicle) in a 1:1:1:1 allocation ratio.

Drug: AMA0076

AMA0076 0.50%

EXPERIMENTAL

Eligible subjects who meet the inclusion/exclusion criteria will be randomized to active or placebo (vehicle) in a 1:1:1:1 allocation ratio.

Drug: AMA0076

Placebo

PLACEBO COMPARATOR

Eligible subjects who meet the inclusion/exclusion criteria will be randomized to active or placebo (vehicle) in a 1:1:1:1 allocation ratio.

Drug: Placebo

Interventions

AMA0076 DRUG

AMA0076 0.1%; AMA0076 0.25%; AMA0076 0.50%

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[after a washout phase in those subjects who were receiving ocular hypotensive therapy\]).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amakem, NV: lead

Study Sites (9)

Artesia Clinical - Site 11

Artesia, California, United States

Location

Inglewood Clinical Site - Site 15

Inglewood, California, United States

Location

Petaluma Clinical Site - Site 17

Petaluma, California, United States

Location

Morrow Clinical Site - Site13

Morrow, Georgia, United States

Location

Roswell Clinical Site - Site 18

Roswell, Georgia, United States

Location

Rochester Clinical Site - Site 12

Rochester, New York, United States

Location

Slingerlands Clinical Site - Site 19

Slingerlands, New York, United States

Location

Charlotte Clinical Site - Site 14

Charlotte, North Carolina, United States

Location

High Point Clinical Site - Site 16

High Point, North Carolina, United States

Location

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2014
• First Posted: May 13, 2014
• Study Start: April 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 21, 2015

Record last verified: 2015-01

Locations

US (9)