NCT01123785

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

Completed Phase 1/Phase 2 Last updated 11 October 2012

What this trial tests

Phase 1/Phase 2 trial testing INO-8875 in Glaucoma in 144 participants. Completed in 1 January 2012.

Timeline

1 May 2010

Primary endpoint
1 December 2011

1 January 2012

Quick facts

Lead sponsor	Inotek Pharmaceuticals Corporation
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	144
Start date	1 May 2010
Primary completion	1 December 2011
Estimated completion	1 January 2012
Sites	1 location across United States

Drugs / interventions tested

• INO-8875 — full drug profile →
• Placebo

Conditions studied

• Glaucoma — all drugs for Glaucoma →
• Ocular Hypertension — all drugs for Ocular Hypertension →

Sponsor

Inotek Pharmaceuticals Corporation — full company profile →

Who can join

Adults 18 to 77, any sex, with Glaucoma or Ocular Hypertension. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Adenosine receptors as drug targets--what are the challenges?
   Chen JF, Eltzschig HK, Fredholm BB. · · 2013 · cited 678× · PMID 23535933 · DOI 10.1038/nrd3955
2. Current understanding of conventional outflow dysfunction in glaucoma.
   Stamer WD, Acott TS. · · 2012 · cited 277× · PMID 22262082 · DOI 10.1097/icu.0b013e32834ff23e
3. Adenosine A1 and A2A Receptors in the Brain: Current Research and Their Role in Neurodegeneration.
   Stockwell J, Jakova E, Cayabyab FS. · · 2017 · cited 142× · PMID 28441750 · DOI 10.3390/molecules22040676
4. Novel ocular antihypertensive compounds in clinical trials.
   Chen J, Runyan SA, Robinson MR. · · 2011 · cited 71× · PMID 21629573 · DOI 10.2147/opth.s15971
5. A Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of 2 and 4 Weeks of Twice-Daily Ocular Trabodenoson in Adults with Ocular Hypertension or Primary Open-Angle Glaucoma.
   Myers JS, Sall KN, DuBiner H, Slomowitz N, et al · · 2016 · cited 30× · PMID 27002298 · DOI 10.1089/jop.2015.0148
6. Targeting Schlemm's Canal in the Medical Therapy of Glaucoma: Current and Future Considerations.
   Andrés-Guerrero V, García-Feijoo J, Konstas AG. · · 2017 · cited 26× · PMID 28349508 · DOI 10.1007/s12325-017-0513-z
7. Glaucoma: Novel antifibrotic therapeutics for the trabecular meshwork.
   Qin M, Yu-Wai-Man C. · · 2023 · cited 16× · PMID 37391006 · DOI 10.1016/j.ejphar.2023.175882
8. Challenging glaucoma with emerging therapies: an overview of advancements against the silent thief of sight.
   Sarkis S, Chamard C, Johansen B, Daien V, et al · · 2025 · cited 5× · PMID 40206485 · DOI 10.3389/fmed.2025.1527319