ATS907 Ph2a Open-Label Dose-ranging Safety and Tolerability in Primary Open Angle Glaucoma (POAG) and Ocular Hypertension (OHT) Subjects

Phase 2

Completed

• Conditions: Primary Open Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: ATS907

• Registration Number: NCT01668524
• Lead Sponsor: Altheos, Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Study First Submitted: 2012-08-14
• Study First Submitted QC: 2012-08-16
• Study First Posted: 2012-08-20
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-05
• Last Update Posted: 2012-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm: ATS907	ATS907	Single-cohort, dose-escalation

Primary Outcome Measures

Name	Time	Method
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	3 weeks

Trial Locations

Locations (1)

Sall Research Medical Center; 🇺🇸 Artesia, California, United States