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CompletedNCT01123785Updated Oct 15, 2012

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 1/2 interventional study of INO-8875 and Placebo in Glaucoma and Ocular Hypertension, sponsored by Inotek Pharmaceuticals Corporation. Completed at 1 site in United States. Open to participants aged 18 Years to 77 Years. Per ClinicalTrials.gov, last updated 2012-10-15.

Sponsored by Inotek Pharmaceuticals Corporation · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
144
Allocation
Randomized
Ages
18 Years to 77 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Glaucoma
  • Ocular Hypertension

Keywords

  • glaucoma
  • ocular hypertension
  • adenosine agonist
  • eye drop
  • primary open angle glaucoma
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 144 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Inotek Pharmaceuticals Corporation is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 77 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
144 participants (actual)

Study arms

  • Placebo comparator
    Control

    Matched vehicle-control

    Drug: Placebo

  • Experimental
    INO-8875

    Adenosine agonist eye drop

    Drug: INO-8875

Interventions

  • DrugINO-8875

    eye drops for 14 days in one eye

  • DrugPlacebo

    Matched vehicle-control

06

What researchers measure

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

07

Study locations

1 site
  • Lugene Eye Institute
    Glendale, California 91205, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01123785
Lead sponsor
Inotek Pharmaceuticals Corporation
Responsible party
Sponsor
First posted
May 14, 2010
Start date
May 2010
Primary completion
Dec 2011
Completion
Jan 2012
Last update
Oct 15, 2012

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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