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

Primary Purpose

Glaucoma, Ocular Hypertension, Eye Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AMA0076
Placebo
Sponsored by
Amakem, NV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Artesia Clinical - Site 11
  • Inglewood Clinical Site - Site 15
  • Petaluma Clinical Site - Site 17
  • Morrow Clinical Site - Site13
  • Roswell Clinical Site - Site 18
  • Rochester Clinical Site - Site 12
  • Slingerlands Clinical Site - Site 19
  • Charlotte Clinical Site - Site 14
  • High Point Clinical Site - Site 16

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

AMA0076 0.1%

AMA0076 0.25%

AMA0076 0.50%

Placebo

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Mean change from baseline in mean diurnal intraocular pressure

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 9, 2014
Last Updated
January 16, 2015
Sponsor
Amakem, NV
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1. Study Identification

Unique Protocol Identification Number
NCT02136940
Brief Title
Multiple Dose-parallel-group Study of AMA0076 in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amakem, NV

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension, Eye Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AMA0076 0.1%
Arm Type
Experimental
Arm Description
Eligible subjects who meet the inclusion/exclusion criteria will be randomized to active or placebo (vehicle) in a 1:1:1:1 allocation ratio.
Arm Title
AMA0076 0.25%
Arm Type
Experimental
Arm Description
Eligible subjects who meet the inclusion/exclusion criteria will be randomized to active or placebo (vehicle) in a 1:1:1:1 allocation ratio.
Arm Title
AMA0076 0.50%
Arm Type
Experimental
Arm Description
Eligible subjects who meet the inclusion/exclusion criteria will be randomized to active or placebo (vehicle) in a 1:1:1:1 allocation ratio.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Eligible subjects who meet the inclusion/exclusion criteria will be randomized to active or placebo (vehicle) in a 1:1:1:1 allocation ratio.
Intervention Type
Drug
Intervention Name(s)
AMA0076
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Mean change from baseline in mean diurnal intraocular pressure
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
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.
Time Frame
4 weeks
Title
Compare the safety and tolerability of topically administered AMA0076 compared to vehicle, by evaluation of safety variables
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Artesia Clinical - Site 11
City
Artesia
State/Province
California
Country
United States
Facility Name
Inglewood Clinical Site - Site 15
City
Inglewood
State/Province
California
Country
United States
Facility Name
Petaluma Clinical Site - Site 17
City
Petaluma
State/Province
California
Country
United States
Facility Name
Morrow Clinical Site - Site13
City
Morrow
State/Province
Georgia
Country
United States
Facility Name
Roswell Clinical Site - Site 18
City
Roswell
State/Province
Georgia
Country
United States
Facility Name
Rochester Clinical Site - Site 12
City
Rochester
State/Province
New York
Country
United States
Facility Name
Slingerlands Clinical Site - Site 19
City
Slingerlands
State/Province
New York
Country
United States
Facility Name
Charlotte Clinical Site - Site 14
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
High Point Clinical Site - Site 16
City
High Point
State/Province
North Carolina
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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