A Dose-Escalation Study Designed to Evaluate the Tolerability, Safety, Pharmacokinetics (PK), and Efficacy of Chronic Topical Ocular Application of INO-8875 in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma

Glaucoma Clinical Trial

Official title:

A Phase I/II Multi-Center, Randomized, Double-Masked, Placebo-Controlled, Dose-Escalation Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics (Efficacy) of Chronic Twice-Daily Topical Monocular Application of INO-8875 Ophthalmic Formulation in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01123785
• Other study ID #: IPC-10-2009
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 27, 2010
• Last updated: October 11, 2012
• Start date: May 2010
• Est. completion date: January 2012

Study information

• Verified date: October 2012
• Source: Inotek Pharmaceuticals Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate how tolerable, safe, and effective it is to give INO-8875 eye drops to adults with glaucoma or ocular hypertension.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 77 Years

Eligibility

Inclusion Criteria:

1. Subject has the diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG).

2. Aged 18 to 75 years.

3. Mean intraocular pressure (IOP) of =24 and =34 mm Hg.

Exclusion Criteria:

1. No significant visual field loss or any new field loss within the past year.

2. Cup-to-disc ratio =0.8

3. Central corneal thickness <500 µm or >600 µm

4. History of adult asthma or chronic obstructive pulmonary disease

5. A recent (acute) or chronic medical condition that might obfuscate the Subject's study data

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• INO-8875
eye drops for 14 days in one eye
• Placebo
Matched vehicle-control

Locations

Country	Name	City	State
United States	Lugene Eye Institute	Glendale	California

Sponsors (1)

Lead Sponsor	Collaborator
Inotek Pharmaceuticals Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		14 days	Yes
Secondary	Number of Participants with decreased Intra-ocular pressure		14 days	Yes