MRCT Evaluating NCX 470 vs. Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension

• Status: Recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

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 subjecs with ocular hypertension or open-angle glaucoma. Subjects will be randomized in a 1:1 ratio to NCX 470 0.1% or to latanoprost 0.005% to be administered to both eyes once daily in the evening for up to 12 months.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nicox Ophthalmics, Inc.
• Treatments: Latanoprost

Criteria

Inclusion Criteria:

• Diagnosis of open-angle glaucoma or ocular hypertension in both eyes

• Qualifying IOP at 3 time points through the day at 2 visits following washout of IOP-lowering medication, if applicable

• Qualifying best-corrected visual acuity in each eye

• Ability to provide informed consent and follow study instructions

Exclusion Criteria:

• 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