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

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ClinicalTrials.gov Identifier: NCT01693315
Recruitment Status : Completed
First Posted : September 26, 2012
Last Update Posted : July 17, 2013
Sponsor:
Information provided by (Responsible Party):
Amakem, NV

Tracking Information
First Submitted Date  ICMJE September 21, 2012
First Posted Date  ICMJE September 26, 2012
Last Update Posted Date July 17, 2013
Study Start Date  ICMJE September 2012
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2012)
intraocular pressure change from baseline. [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2012)
  • Adverse events as a measure of safety/tolerability [ Time Frame: 4 weeks ]
  • IOP assessments at weekly visits [ Time Frame: Weeks 1, 2, 3, 4 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multiple Dose-escalation Study of AMA0076 in Patients With Ocular Hypertension or Primary Open-angle Glaucoma
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Glaucoma
  • Ocular Hypertension
  • Eye Disease
Intervention  ICMJE
  • Drug: AMA0076
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Cohort 1 - AMA0076 Dose A (or vehicle)
    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).
    Interventions:
    • Drug: AMA0076
    • Drug: Placebo
  • Experimental: Cohort 2: AMA0076 Dose B (or vehicle)
    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).
    Interventions:
    • Drug: AMA0076
    • Drug: Placebo
  • Experimental: Cohort 3: AMA0076 Dose C (or vehicle)
    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).
    Interventions:
    • Drug: AMA0076
    • Drug: Placebo
  • Experimental: Cohort 4: AMA0076 Dose D (or vehicle)
    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).
    Interventions:
    • Drug: AMA0076
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 16, 2013)
82
Original Estimated Enrollment  ICMJE
 (submitted: September 25, 2012)
80
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01693315
Other Study ID Numbers  ICMJE AMA0076-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amakem, NV
Study Sponsor  ICMJE Amakem, NV
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Amakem, NV
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP