Phase 2 Dose-Response Study Evaluating the Safety and Efficacy of NCX 470 vs Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension
| Status: | Recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 3/16/2019 |
| Start Date: | August 1, 2018 |
| End Date: | December 2019 |
| Contact: | Nicox Ophthalmics, Inc. |
| Email: | NCX470@nicox.com |
| Phone: | 919-314-8374 |
A Phase 2, Randomized, Multicenter, Masked, Parrallel-Group, Dose-Response Study Evaluating the Safety and Efficacy of NCX 470 (3 Doses: 0.021%, 0.042%, and 0.065%) vs. Latanoprost 0.005% in Subjects With Open-Angle Glaucoma or Ocular Hypertension
The objective of this clinical study is to evaluate the safety and efficacy of NCX 470
ophthalmic solution in lowering intraocular pressure (IOP) in patients with ocular
hypertension or open-angle glaucoma. Three different concentrations of NCX 470 ophthalmic
solution (0.021%, 0.042%, and 0.065%) will be compared to latanoprost 0.005% ophthalmic
solution.
ophthalmic solution in lowering intraocular pressure (IOP) in patients with ocular
hypertension or open-angle glaucoma. Three different concentrations of NCX 470 ophthalmic
solution (0.021%, 0.042%, and 0.065%) will be compared to latanoprost 0.005% ophthalmic
solution.
Inclusion Criteria:
- Diagnosis of open-angle glaucoma or ocular hypertension in both eyes
- Qualifying IOP at 3 time points throughout the day at 2 visits following washout of
IOP-lowering medication, if applicable
- Qualifying best-corrected visual acuity (BCVA) using the Early Treatment of Diabetic
Retinopathy Study (ETDRS) protocol in each eye
- Ability to provide informed consent and follow study instructions
Exclusion Criteria:
- Pigmentary or pseudoexfoliative glaucoma
- Narrow anterior chamber angles or disqualifying corneal thickness in either eye
- Clinically significant ocular disease in either eye
- Previous complicated surgery or certain types of glaucoma surgery in either eye
- Incisional ocular surgery or severe trauma in either eye within the past 6 months
- Uncontrolled systemic disease
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