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OpenTrials
Completed

NCT Number: NCT01123785

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

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.

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Key information

Conditions

Glaucoma Eye Diseases Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year–77 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Lugene Eye Institute

Glendale, California, 91205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject has the diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG).
  • Aged 18 to 75 years.
  • Mean intraocular pressure (IOP) of ≥24 and ≤34 mm Hg.

Exclusion criteria

  • No significant visual field loss or any new field loss within the past year.
  • Cup-to-disc ratio ≥0.8
  • Central corneal thickness <500 µm or >600 µm
  • History of adult asthma or chronic obstructive pulmonary disease
  • A recent (acute) or chronic medical condition that might obfuscate the Subject's study data

Treatment and study plan

INO-8875

Drug

eye drops for 14 days in one eye

Placebo

Drug

Matched vehicle-control

Primary outcomes

  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: 14 days

Secondary outcomes

  1. Number of Participants with decreased Intra-ocular pressure

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Inotek Pharmaceuticals Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
May 14, 2010
Registry last updated
Oct 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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