A Phase 2a Open-Label, Dose-ranging Study of the Safety and Tolerability of ATS907 in Subjects With Primary Open Angle Glaucoma and Ocular Hypertension

Altheos, Inc.1 site in 1 country12 target enrollmentAugust 2012

ConditionsPrimary Open Angle Glaucoma Ocular Hypertension

InterventionsATS907

DrugsATS907

Overview

Phase: Phase 2
Intervention: ATS907
Conditions: Primary Open Angle Glaucoma
Sponsor: Altheos, Inc.
Enrollment: 12
Locations: 1
Primary Endpoint: Evaluate local ocular safety and tolerability: change from baseline in ocular tolerability signs and symptoms (hyperemia, irritation, pain, tearing) using ocular tolerability and hyperemia grading scales; and change from baseline for vital signs
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This single-site, dose-escalation study will evaluate safety and tolerability of increasing concentrations of ATS907 in 12 subjects with Primary Open Angle Glaucoma and/or Ocular Hypertension

Registry

clinicaltrials.gov

Start Date

August 2012

End Date

August 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Altheos, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•18 years of age or greater
•Diagnosis of open angle glaucoma or ocular hypertension in both eyes
•Corrected visual acuity in each eye +1.0 logMAR or better by Early Treatment Diabetic Retinopathy Study (EDTRS) 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):
•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). Refractive surgery in study eye
•Cataract surgery and or other intraocular surgery within one month 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

Arms & Interventions

Single Arm: ATS907

Single-cohort, dose-escalation

Intervention: ATS907

Outcomes

Primary Outcomes

Evaluate local ocular safety and tolerability: change from baseline in ocular tolerability signs and symptoms (hyperemia, irritation, pain, tearing) using ocular tolerability and hyperemia grading scales; and change from baseline for vital signs

Time Frame: 3 weeks