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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Altheos, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Altheos, Inc.
ClinicalTrials.gov Identifier:
NCT01520116
First received: January 25, 2012
Last updated: October 30, 2012
Last verified: October 2012
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Altheos, Inc.:

Primary Outcome Measures:
  • Mean Change in Intraocular Pressure from Baseline [ Time Frame: Stage 1: Days 14, 21 and 28; Stage 2: Day 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Observed Intraocular Pressure and % change from Baseline IOP [ Time Frame: Stage 1: Days 0, 1, 4, 14, 21, 28; Stage 2: Days 0, 4 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: January 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided

Responsible Party: Altheos, Inc.
ClinicalTrials.gov Identifier: NCT01520116     History of Changes
Other Study ID Numbers: ATS907-201
Study First Received: January 25, 2012
Last Updated: October 30, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014