Phase 3 Trial of NCX 470 vs. Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Phase 3, Randomized, Adaptive Dose-Selection, Multi-regional, Double-Masked, Parallel-Group, 3-Month Trial Evaluating the Safety and Efficacy of NCX 470 vs. Latanoprost 0.005% in Subjects With Open-Angle Glaucoma or Ocular Hypertension (Mont Blanc)

Sponsors

Lead Sponsor: Nicox Ophthalmics, Inc.

Source Nicox Ophthalmics, Inc.
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. In the adaptive dose selection phase of the trial, subjects will be randomized in a 1:1:1 ratio to one of two doses of NCX 470 (0.065% or 0.1%) or to latanoprost 0.005%. Following the selection of one dose of NCX 470, subjects will be randomized in a 1:1 ratio to the chosen dose of NCX 470 or to latanoprost 0.005%.

Overall Status Recruiting
Start Date 2020-06-01
Completion Date 2022-06-01
Primary Completion Date 2022-06-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Reduction from baseline IOP in the study eye 3 months
Secondary Outcome
Measure Time Frame
Reduction from baseline in diurnal IOP in the study eye 3 months
Frequency and incidence of treatment-emergent adverse events 3 months
Rate of discontinuation 3 months
Enrollment 670
Condition
Intervention

Intervention Type: Drug

Intervention Name: NCX 470 0.065%

Description: NCX 470 Ophthalmic Solution, 0.065%

Arm Group Label: NCX 470 0.065%

Other Name: NCX 470

Intervention Type: Drug

Intervention Name: NCX 470 0.1%

Description: NCX 470 Ophthalmic Solution, 0.1%

Arm Group Label: NCX 470 0.1%

Other Name: NCX 470

Intervention Type: Drug

Intervention Name: Latanoprost 0.005%

Description: Latanoprost Ophthalmic Solution, 0.005%

Arm Group Label: Latanoprost 0.005%

Other Name: Latanoprost

Eligibility

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

84 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Jose L Boyer, PhD Study Director Nicox Ophthalmics, Inc.
Overall Contact

Last Name: Sushanta Mallick, PhD

Phone: 2148684744

Email: [email protected]

Location
Facility: Status: Contact: Eye Research Foundation Sushanta Mallick, PhD 214-868-4744 [email protected]
Location Countries

United States

Verification Date

2021-03-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: NCX 470 0.065%

Type: Experimental

Description: NCX 470 Ophthalmic Solution, 0.065% dosed once daily to both eyes

Label: NCX 470 0.1%

Type: Experimental

Description: NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes

Label: Latanoprost 0.005%

Type: Active Comparator

Description: Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes

Acronym Mont Blanc
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Masking Description: double-masked

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