A Phase II Study to Evaluate the Additivity of Trabodenoson to Latanoprost in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/3/2017 |
| Start Date: | August 2013 |
| End Date: | September 2014 |
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).
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
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
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
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