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Study of the Safety and Efficacy of ATS907 in Subjects With Primary Open Angle Glaucoma (POAG) and Ocular Hypertension

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ClinicalTrials.gov Identifier: NCT01520116
Recruitment Status : Unknown
Verified October 2012 by Altheos, Inc..
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2012
Last Update Posted : November 1, 2012
Sponsor:
Information provided by (Responsible Party):
Altheos, Inc.

Brief Summary:
This randomized dose-ranging study will evaluate the safety, tolerability, and preliminary efficacy (reduction in intraocular pressure) of multiple dose levels of ATS907, vehicle, or latanoprost in subjects with primary open angle glaucoma or ocular hypertension. In the first portion, approximately 75 subjects will be randomized to receive either ATS907 or vehicle eye drops for up to 28 days, administered both once and twice daily. In the second portion, up to 180 subjects will be randomized to receive either ATS907 or latanoprost for up to 28 days. Plasma pharmacokinetics will also be evaluated during the first portion of the study.

Condition or disease Intervention/treatment Phase
Primary Open Angle Glaucoma Ocular Hypertension Drug: Stage 1 - ATS907 - Dose 1 Drug: Stage 1 - ATS907 - Dose 2 Drug: Stage 1 - ATS907 - Dose 3 Drug: Stage 1 - ATS907 - Dose 4 Drug: Stage 1 - Vehicle Drug: Stage 2 - ATS907 - Dose A - to be selected based on Stage 1 Drug: Stage 2 - ATS907 - Dose B - to be selected based on Stage 1 Drug: Timoptic Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1/2a Randomized, Investigator-masked, Placebo- and Active-controlled, Dose-ranging Study of the Safety and Efficacy of ATS907 in Subjects With Primary Open Angle Glaucoma (POAG) and Ocular Hypertension
Study Start Date : January 2012
Estimated Primary Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Stage 1 - Arm 1 - Dose 1 Drug: Stage 1 - ATS907 - Dose 1
QD and/or BID dosing for 28 days
Experimental: Stage 1 - Arm 2 - Dose 2 Drug: Stage 1 - ATS907 - Dose 2
QD and/or BID dosing for 28 days
Experimental: Stage 1 - Arm 3 - Dose 3 Drug: Stage 1 - ATS907 - Dose 3
QD and/or BID dosing for 28 days
Experimental: Stage 1 - Arm 4 - Dose 4 Drug: Stage 1 - ATS907 - Dose 4
QD and/or BID dosing for 28 days
Placebo Comparator: Stage 1 - Arm 5 - Vehicle Drug: Stage 1 - Vehicle
QD and/or BID dosing for 28 days
Experimental: Stage 2 - Arm 1 - Dose A - to be selected based on Stage 1 Drug: Stage 2 - ATS907 - Dose A - to be selected based on Stage 1
QD and/or BID dosing for 4 days
Experimental: Stage 2 - Arm 2 - Dose B - to be selected based on Stage 1 Drug: Stage 2 - ATS907 - Dose B - to be selected based on Stage 1
QD and/or BID dosing for 4 days
Active Comparator: Stage 2 - Arm 3 -Timoptic 0.5% BID Drug: Timoptic
0.5%



Primary Outcome Measures :
  1. Mean Change in Intraocular Pressure from Baseline [ Time Frame: Stage 1: Days 14, 21 and 28; Stage 2: Day 4 ]

Secondary Outcome Measures :
  1. Observed Intraocular Pressure and % change from Baseline IOP [ Time Frame: Stage 1: Days 0, 1, 4, 14, 21, 28; Stage 2: Days 0, 4 ]
  2. Mean observed, mean change from Baseline and mean % change from Baseline for the mean diurnal IOP [ Time Frame: Stage 1: Days 0, 1, 4, 14, 21, 28; Stage 2: Days 0, 4 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or greater
  • Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT) in both eyes
  • Unmedicated (post-washout) IOP ≥ 23 mm Hg at 2 eligibility visits: 07:00-09:00 hr on Days O and 1 and IOP > 18 mm Hg at 15:00-17:00 on Day 0 (Stage 1)
  • Unmedicated (post-washout) IOP criteria after wash out < 32 mm Hg OU at all times points (Stage 1)
  • Unmedicated (post-washout) IOP ≥ 24 mm Hg at 2 eligibility visits: 07:00-09:00 hr on Days O and 1 and IOP > 21 mm Hg at 9:00-17:00 on Day 0 (Stage 2)
  • Unmedicated (post-washout) IOP criteria after wash out < 36 mm Hg OU at all times points (Stage 2)
  • Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200)
  • Must be willing to discontinue the use of all ocular hypotensive medications in both eyes prior to and during the entire course of the study

Exclusion Criteria:

  • Ophthalmic (in either eye)

    1. Glaucoma: pseudoexfoliation, steroid induced, pigment dispersion glaucoma, and or history of angle closure. Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s). Prior laser glaucoma surgery is permitted in the non study eye
    2. Refractive surgery in study eye (e.g., radial keratotomy, PRK, LASIK, etc.)
    3. Cataract surgery and or other intraocular surgery within three months prior to Screening in either eye.
    4. History within 3 months prior to Screening of clinically significant moderate or severe chronic or active ocular infection, inflammation, blepharitis, dermatitis, uveitis or conjunctivitis.
    5. Clinically significant corneal dystrophy, epithelial and or endothelial disease, corneal irregularities and or scarring such that reliable applanation tonometry would prevented.
    6. Contact lens wear during the duration of the study.
    7. Clinically significant ocular disease (e.g. diabetic retinopathy, macular degeneration, or uveitis) which might interfere or progress during the study.
    8. Central corneal thickness < 480 or > 600 μm in the study eye
  • Systemic

    1. Clinically significant abnormalities in laboratory tests at screening.
    2. Clinically significant systemic disease (e.g., uncontrolled diabetes, uncontrolled hyper or hypotension, hepatic, renal, endocrine or cardiovascular disorders). Participation in any investigational study within the past 30 days.
    3. Changes of systemic medication that could have a substantial effect on IOP and or systemic blood pressure within 7 days prior to Baseline (Day 0).
    4. Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. An adult woman is considered to be of childbearing potential unless she is one year post-menopausal or three months post-surgical sterilization. All females of childbearing potential must have a negative urine pregnancy test result at the Screening visit and a negative urine and serum pregnancy at Baseline (Day 0) and must not intend to become pregnant during the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01520116


Locations
United States, California
Artesia, California, United States
Glendale, California, United States
United States, Michigan
St. Joseph, Michigan, United States
United States, Ohio
Cleveland, Ohio, United States
United States, Texas
San Antonio, Texas, United States
Sponsors and Collaborators
Altheos, Inc.
Investigators
Study Chair: Barbara Wirostko, MD Altheos, Inc.

Responsible Party: Altheos, Inc.
ClinicalTrials.gov Identifier: NCT01520116     History of Changes
Other Study ID Numbers: ATS907-201
First Posted: January 27, 2012    Key Record Dates
Last Update Posted: November 1, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Timolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents