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A Phase II Study to Evaluate the Additivity of Trabodenoson to Latanoprost in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01917383
Enrollment
101
Registered
2013-08-06
Start date
2013-08-31
Completion date
2014-09-30
Last updated
2017-12-02

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

Conditions

Ocular Hypertension (OHT), Primary Open-Angle Glaucoma (POAG)

Keywords

glaucoma, primary open angle glaucoma, ocular hypertension, adenosine agonist, eye drop, trabodenoson, trabecular meshwork

Brief summary

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).

Detailed description

Criteria Inclusion Criteria: 1. Subject has signed and dated the current informed consent form (ICF). 2. Subject has the diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG) (excluding secondary, pseudo-exfoliation, and pigment dispersion glaucomas). 3. Aged 18 or older. 4. 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. A recent (acute) or chronic medical condition that might obfuscate the Subject's study data

Interventions

DRUGTrabodenoson

Ophthalmic eye drop

DRUGLatanoprost

Ophthalmic eye drop

DRUGTimolol

Ophthalmic eye drop

Sponsors

Inotek Pharmaceuticals Corporation
Lead SponsorINDUSTRY

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 No maximum
Healthy volunteers
No

Inclusion criteria

1. Subject has signed and dated the current informed consent form (ICF). 2. Subject has the diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG) (excluding secondary, pseudo-exfoliation, and pigment dispersion glaucomas). 3. Aged 18 or older. 4. 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. A recent (acute) or chronic medical condition that might obfuscate the Subject's study data

Design outcomes

Primary

MeasureTime frame
Intraocular Pressure (IOP)12 weeks

Countries

United States

Outcome results

None listed

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