NCT01917383

A Phase II Multi-center, Randomized Study to Evaluate the Monocular Addition of Trabodenoson (INO-8875) Ophthalmic Formulation to Latanoprost Ophthalmic Solution Therapy in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma

Completed Phase 2 Last updated 28 November 2017

What this trial tests

Phase 2 trial testing Trabodenoson in Primary Open-Angle Glaucoma (POAG) in 101 participants. Completed in 1 September 2014.

Timeline

1 August 2013

Primary endpoint
1 August 2014

1 September 2014

Quick facts

Lead sponsor	Inotek Pharmaceuticals Corporation
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	101
Start date	1 August 2013
Primary completion	1 August 2014
Estimated completion	1 September 2014
Sites	1 location across United States

Drugs / interventions tested

• Trabodenoson — full drug profile →
• Latanoprost (LATANOPROST) — full drug profile →
• Timolol — full drug profile →

Conditions studied

• Primary Open-Angle Glaucoma (POAG) — all drugs for Primary Open-Angle Glaucoma (POAG) →
• Ocular Hypertension (OHT) — all drugs for Ocular Hypertension (OHT) →

Sponsor

Inotek Pharmaceuticals Corporation — full company profile →

Who can join

18 and older, any sex, with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OHT). 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.

• Intraocular Pressure (IOP)
  Time frame: 12 weeks

Sponsor's own description

The purpose of this study is to evaluate the intraocular pressure (IOP) lowering efficacy and the safety and tolerability profile of trabodenoson ophthalmic formulation compared to timolol maleate ophthalmic solution 0.5% in adults with ocular hypertension (OHT) or primary open-angle glaucoma (POAG) who are already receiving treatment with latanoprost ophthalmic solution 0.005% once every evening (QPM).

Publications & conference data

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

1. Biomechanics of Schlemm's canal endothelium and intraocular pressure reduction.
   Stamer WD, Braakman ST, Zhou EH, Ethier CR, et al · · 2015 · cited 134× · PMID 25223880 · DOI 10.1016/j.preteyeres.2014.08.002
2. Present and New Treatment Strategies in the Management of Glaucoma.
   M K. · · 2015 · cited 33× · PMID 26069521 · DOI 10.2174/1874364101509010089
3. 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
4. Current situation and progress of drugs for reducing intraocular pressure.
   Liu P, Wang F, Song Y, Wang M, et al · · 2022 · cited 17× · PMID 36479139 · DOI 10.1177/20406223221140392
5. 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
6. 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