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

Ocular Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01668524
• Other study ID #: ATS907-205
• Status: Completed
• Phase: Phase 2
• First received: August 14, 2012
• Last updated: September 5, 2012
• Start date: August 2012
• Est. completion date: August 2012

Study information

• Verified date: September 2012
• Source: Altheos, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Primary Open Angle Glaucoma

Intervention

Drug:
• ATS907
Single dose of each of three increasing concentrations

Locations

Country	Name	City	State
United States	Sall Research Medical Center	Artesia	California

Sponsors (1)

Lead Sponsor	Collaborator
Altheos, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes