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

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ClinicalTrials.gov Identifier: NCT03657797
Recruitment Status : Recruiting
First Posted : September 5, 2018
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
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. Three different concentrations of NCX 470 ophthalmic solution (0.021%, 0.042%, and 0.065%) will be compared to latanoprost 0.005% ophthalmic solution.

Condition or disease Intervention/treatment Phase
Glaucoma, Open-Angle Hypertension, Ocular Drug: NCX 470 Drug: Latanoprost 0.005% Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Latanoprost

Arm Intervention/treatment
Experimental: NCX 470 0.021%
NCX 470 Ophthalmic Solution, 0.021% dosed once daily for 4 weeks
Drug: NCX 470
NCX 470 Ophthalmic Solution

Experimental: NCX 470 0.042%
NCX 470 Ophthalmic Solution, 0.042% dosed once daily for 4 weeks
Drug: NCX 470
NCX 470 Ophthalmic Solution

Experimental: NCX 470 0.065%
NCX 470 Ophthalmic Solution, 0.065% dosed once daily for 4 weeks
Drug: NCX 470
NCX 470 Ophthalmic Solution

Active Comparator: Latanoprost 0.005%
Latanoprost Ophthalmic Solution, 0.005% dosed once daily for 4 weeks
Drug: Latanoprost 0.005%
Latanoprost 0.005% Ophthalmic Solution
Other Name: Latanoprost




Primary Outcome Measures :
  1. Reduction from baseline in mean diurnal IOP at the Week 4 Visit in the study eye [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Number of subjects with adverse events as a measure of safety and tolerability [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03657797


Contacts
Contact: Nicox Ophthalmics, Inc. 919-314-8374 NCX470@nicox.com
Contact: Krisi Lopez 956-459-7062 lopez@nicox.com

Locations
United States, Texas
Texan Eye Recruiting
Austin, Texas, United States, 78731
Contact: Robert Stapper         
Sponsors and Collaborators
Nicox Ophthalmics, Inc.
Investigators
Study Director: Tomas Navratil, PhD Nicox Ophthalmics, Inc.

Responsible Party: Nicox Ophthalmics, Inc.
ClinicalTrials.gov Identifier: NCT03657797     History of Changes
Other Study ID Numbers: NCX-470-17001
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Latanoprost
Antihypertensive Agents