Phase 2 Completed N=433 Randomized Quadruple-blind Treatment

Phase 2 Dose-Response Study Evaluating the Safety and Efficacy of NCX 470 vs Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Glaucoma, Open-Angle · Hypertension, Ocular

Source: ClinicalTrials.gov NCT03657797 ↗

Enrolled (actual)

433

Serious AEs

0.9%

Results posted

Dec 2022

Primary outcomePrimary: Change From Baseline in Study Eye Mean Diurnal IOP at the Week 4 — -7.79; -8.28; -8.70; -7.41 mmHg — p=0.2666

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Study Eye Mean Diurnal IOP at the Week 4	-7.79; -8.28; -8.70; -7.41	0.2666
SECONDARY Change From Baseline in Study Eye Mean Diurnal IOP at Week 1, Week 2, and Exit Visit	-7.73; -8.15; -8.66; -7.54; -7.96; -8.38	<0.9788
SECONDARY Percentage of Subjects With Treatment-emergent Ocular Adverse Events	34; 52; 50; 21	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03657797). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.