NCT01693315

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 26, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

July 17, 2013

Status Verified

July 1, 2013

Enrollment Period

10 months

First QC Date

September 21, 2012

Last Update Submit

July 16, 2013

Conditions

GlaucomaOcular HypertensionEye Disease

Outcome Measures

Primary Outcomes (1)

  • intraocular pressure change from baseline.

    4 weeks

Secondary Outcomes (2)

  • Adverse events as a measure of safety/tolerability

    4 weeks

  • IOP assessments at weekly visits

    Weeks 1, 2, 3, 4

Study Arms (4)

Cohort 1 - AMA0076 Dose A (or vehicle)

EXPERIMENTAL

Consecutive, eligible subjects who meet the inclusion/exclusion criteria in each cohort will be randomized to active or placebo (vehicle) in a 4:1 allocation ratio (12 active : 3 placebo).

Drug: AMA0076Drug: Placebo

Cohort 2: AMA0076 Dose B (or vehicle)

EXPERIMENTAL

Consecutive, eligible subjects who meet the inclusion/exclusion criteria in each cohort will be randomized to active or placebo (vehicle) in a 4:1 allocation ratio (12 active : 3 placebo).

Drug: AMA0076Drug: Placebo

Cohort 3: AMA0076 Dose C (or vehicle)

EXPERIMENTAL

Consecutive, eligible subjects who meet the inclusion/exclusion criteria in each cohort will be randomized to active or placebo (vehicle) in a 4:1 allocation ratio (20 active : 5 placebo).

Drug: AMA0076Drug: Placebo

Cohort 4: AMA0076 Dose D (or vehicle)

EXPERIMENTAL

Consecutive, eligible subjects who meet the inclusion/exclusion criteria in each cohort will be randomized to active or placebo (vehicle) in a 4:1 allocation ratio (20 active : 5 placebo).

Drug: AMA0076Drug: Placebo

Interventions

AMA0076DRUG
Cohort 1 - AMA0076 Dose A (or vehicle)Cohort 2: AMA0076 Dose B (or vehicle)Cohort 3: AMA0076 Dose C (or vehicle)Cohort 4: AMA0076 Dose D (or vehicle)
PlaceboDRUG
Cohort 1 - AMA0076 Dose A (or vehicle)Cohort 2: AMA0076 Dose B (or vehicle)Cohort 3: AMA0076 Dose C (or vehicle)Cohort 4: AMA0076 Dose D (or vehicle)

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults 30-85 years of age
  • Diagnosis of either ocular hypertension or primary open-angle glaucoma 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 ≤ 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

You may not qualify if:

  • 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).
  • Receiving more than one medication for IOP at time of screening.
  • Central corneal thickness of less than 500 µm or greater than 620 µm.
  • BCVA worse than 20/200 in either eye
  • 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.
  • Acute angle-closure glaucoma or appositional or very narrow anterior chamber angle in either eye.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Artesia Clinical Site - Site 02

Artesia, California, United States

Location

Inglewood Clinical Site - Site 03

Inglewood, California, United States

Location

Petaluma Clinical Site - Site 05

Petaluma, California, United States

Location

New Haven Clinical Site - Site 01

New Haven, Connecticut, United States

Location

Atlanta Clinical Site - Site 04

Atlanta, Georgia, United States

Location

High Point Clinical Site - Site 06

High Point, North Carolina, United States

Location

MeSH Terms

Conditions

GlaucomaOcular HypertensionEye 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

September 21, 2012

First Posted

September 26, 2012

Study Start

September 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

July 17, 2013

Record last verified: 2013-07

Locations

US(6)