NCT01520116

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Last Updated

November 1, 2012

Status Verified

October 1, 2012

Enrollment Period

11 months

First QC Date

January 25, 2012

Last Update Submit

October 30, 2012

Conditions

Primary Open Angle GlaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (1)

  • Mean Change in Intraocular Pressure from Baseline

    Stage 1: Days 14, 21 and 28; Stage 2: Day 4

Secondary Outcomes (2)

  • Observed Intraocular Pressure and % change from Baseline IOP

    Stage 1: Days 0, 1, 4, 14, 21, 28; Stage 2: Days 0, 4

  • Mean observed, mean change from Baseline and mean % change from Baseline for the mean diurnal IOP

    Stage 1: Days 0, 1, 4, 14, 21, 28; Stage 2: Days 0, 4

Study Arms (8)

Stage 1 - Arm 1 - Dose 1

EXPERIMENTAL
Drug: Stage 1 - ATS907 - Dose 1

Stage 1 - Arm 2 - Dose 2

EXPERIMENTAL
Drug: Stage 1 - ATS907 - Dose 2

Stage 1 - Arm 3 - Dose 3

EXPERIMENTAL
Drug: Stage 1 - ATS907 - Dose 3

Stage 1 - Arm 4 - Dose 4

EXPERIMENTAL
Drug: Stage 1 - ATS907 - Dose 4

Stage 1 - Arm 5 - Vehicle

PLACEBO COMPARATOR
Drug: Stage 1 - Vehicle

Stage 2 - Arm 1 - Dose A - to be selected based on Stage 1

EXPERIMENTAL
Drug: Stage 2 - ATS907 - Dose A - to be selected based on Stage 1

Stage 2 - Arm 2 - Dose B - to be selected based on Stage 1

EXPERIMENTAL
Drug: Stage 2 - ATS907 - Dose B - to be selected based on Stage 1

Stage 2 - Arm 3 -Timoptic 0.5% BID

ACTIVE COMPARATOR
Drug: Timoptic

Interventions

Stage 1 - ATS907 - Dose 1DRUG

QD and/or BID dosing for 28 days

Stage 1 - Arm 1 - Dose 1
Stage 1 - ATS907 - Dose 2DRUG

QD and/or BID dosing for 28 days

Stage 1 - Arm 2 - Dose 2
Stage 1 - ATS907 - Dose 3DRUG

QD and/or BID dosing for 28 days

Stage 1 - Arm 3 - Dose 3
Stage 1 - ATS907 - Dose 4DRUG

QD and/or BID dosing for 28 days

Stage 1 - Arm 4 - Dose 4
Stage 1 - VehicleDRUG

QD and/or BID dosing for 28 days

Stage 1 - Arm 5 - Vehicle
Stage 2 - ATS907 - Dose A - to be selected based on Stage 1DRUG

QD and/or BID dosing for 4 days

Stage 2 - Arm 1 - Dose A - to be selected based on Stage 1
Stage 2 - ATS907 - Dose B - to be selected based on Stage 1DRUG

QD and/or BID dosing for 4 days

Stage 2 - Arm 2 - Dose B - to be selected based on Stage 1
TimopticDRUG

0.5%

Stage 2 - Arm 3 -Timoptic 0.5% BID

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Ophthalmic (in either eye)
  • 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
  • Refractive surgery in study eye (e.g., radial keratotomy, PRK, LASIK, etc.)
  • Cataract surgery and or other intraocular surgery within three months prior to Screening in either eye.
  • History within 3 months prior to Screening of clinically significant moderate or severe chronic or active ocular infection, inflammation, blepharitis, dermatitis, uveitis or conjunctivitis.
  • Clinically significant corneal dystrophy, epithelial and or endothelial disease, corneal irregularities and or scarring such that reliable applanation tonometry would prevented.
  • Contact lens wear during the duration of the study.
  • Clinically significant ocular disease (e.g. diabetic retinopathy, macular degeneration, or uveitis) which might interfere or progress during the study.
  • Central corneal thickness \< 480 or \> 600 μm in the study eye
  • Systemic
  • Clinically significant abnormalities in laboratory tests at screening.
  • 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.
  • 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).
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Artesia, California, United States

Location

Unknown Facility

Glendale, California, United States

Location

Unknown Facility

Saint Joseph, Michigan, United States

Location

Unknown Facility

Cleveland, Ohio, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Interventions

Timolol

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesThiadiazolesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorpholinesOxazines

Study Officials

  • Barbara Wirostko, MD

    Altheos, Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2012

First Posted

January 27, 2012

Study Start

January 1, 2012

Primary Completion

December 1, 2012

Last Updated

November 1, 2012

Record last verified: 2012-10

Locations

US(5)