Ocular Hypertension (OHT) Clinical Trial
Official title:
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
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).
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
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02565173 -
Study of Trabodenoson in Adults With Ocular Hypertension or Primary Open-angle Glaucoma
|
Phase 3 | |
Terminated |
NCT02226094 -
Safety and Efficacy of Deep Wave Trabeculoplasty (DWT) in Primary Open Angle Glaucoma and Ocular Hypertension
|
Phase 1/Phase 2 | |
Recruiting |
NCT06016972 -
Qlaris Phase 2 Study of QLS-111 in POAG and/or OHT Patients
|
Phase 2 | |
Completed |
NCT01318252 -
AL-54478 Proof of Concept Study
|
Phase 2 | |
Terminated |
NCT01180062 -
Safety Study of Latanoprost Slow Release Insert
|
Phase 1 | |
Completed |
NCT01670266 -
Single and Multiple Dose Escalation and Two-sequence Crossover Study of ONO-9054 in Patients With Ocular Hypertension or Mild Open-angle Glaucoma
|
Phase 1 | |
Completed |
NCT02829996 -
Study of Fixed-Dose Combinations of Trabodenoson and Latanoprost in Adults With OHT or POAG
|
Phase 2 | |
Recruiting |
NCT06249152 -
Qlaris Study of QLS-111 in Combination With a PGA for OAG and/or OHT Patients
|
Phase 2 |