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



Status:Recruiting
Conditions:High Blood Pressure (Hypertension), Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:Any
Updated:10/21/2012
Start Date:January 2012
Contact:Barbara Wirostko, MD
Email:bwirostko@altheos.com

Use our guide to learn which trials are right for you!

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


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.


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
We found this trial at
4
sites
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Santa Clara, CA
Click here to add this to my saved trials