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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01123785

Enrollment

144

Registered

2010-05-14

Start date

2010-05-31

Completion date

2012-01-31

Last updated

2012-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Ocular Hypertension

Keywords

glaucoma, ocular hypertension, adenosine agonist, eye drop, primary open angle glaucoma

Brief 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.

Interventions

DRUGINO-8875

eye drops for 14 days in one eye

DRUGPlacebo

Matched vehicle-control

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 77 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	14 days

Secondary

Measure	Time frame
Number of Participants with decreased Intra-ocular pressure	14 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026