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
Overview
- Phase
- Phase 2
- Intervention
- NCX 470
- Conditions
- Glaucoma, Open-Angle
- Sponsor
- Nicox Ophthalmics, Inc.
- Enrollment
- 656
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Study Eye Mean Diurnal IOP at the Week 4
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
NCX 470 0.021%
NCX 470 Ophthalmic Solution, 0.021% dosed once daily for 4 weeks
Intervention: NCX 470
NCX 470 0.042%
NCX 470 Ophthalmic Solution, 0.042% dosed once daily for 4 weeks
Intervention: NCX 470
NCX 470 0.065%
NCX 470 Ophthalmic Solution, 0.065% dosed once daily for 4 weeks
Intervention: NCX 470
Latanoprost 0.005%
Latanoprost Ophthalmic Solution, 0.005% dosed once daily for 4 weeks
Intervention: Latanoprost 0.005%
Outcomes
Primary Outcomes
Change From Baseline in Study Eye Mean Diurnal IOP at the Week 4
Time Frame: Baseline, Week 4
Participants used medication in both eyes for 4 weeks with one eye was designated the study eye at baseline. The study eye was defined as the eye with the highest mean diurnal intraocular pressure (IOP) value at baseline (or the right eye if both eyes had the same IOP value at baseline). Mean diurnal IOP at week 4 is the average of the 8AM, 10AM and 4PM IOPs at week 4.
Secondary Outcomes
- Change From Baseline in Study Eye Mean Diurnal IOP at Week 1, Week 2, and Exit Visit(Baseline, week 1, week 2, exit visit)
- Percentage of Subjects With Treatment-emergent Ocular Adverse Events(4 weeks for adverse events and through 30 days post-treatment for serious adverse events)