Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03657797
Other study ID # NCX-470-17001
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date August 1, 2018
Est. completion date August 23, 2019

Study information

Verified date June 2023
Source Nicox Ophthalmics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 656
Est. completion date August 23, 2019
Est. primary completion date August 23, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Study Design


Intervention

Drug:
NCX 470
NCX 470 Ophthalmic Solution
Latanoprost 0.005%
Latanoprost 0.005% Ophthalmic Solution

Locations

Country Name City State
United States Texan Eye Austin Texas

Sponsors (1)

Lead Sponsor Collaborator
Nicox Ophthalmics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline in Study Eye Mean Diurnal IOP at the 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. Baseline, Week 4
Secondary Change From Baseline in Study Eye Mean Diurnal IOP at Week 1, Week 2, and Exit Visit Participants used medication in both eyes from baseline to the evening prior to the week 4 visit. 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 is the average of the 8AM, 10AM and 4PM values. Visits were conducted at week 1, week 2, week 4, and an exit visit (1 to 2 days following the week 4 visit) Baseline, week 1, week 2, exit visit
Secondary Percentage of Subjects With Treatment-emergent Ocular Adverse Events Safety and tolerability based on percentage of subjects with treatment-emergent ocular adverse events 4 weeks for adverse events and through 30 days post-treatment for serious adverse events
See also
  Status Clinical Trial Phase
Completed NCT05044793 - A Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System
Recruiting NCT06201455 - Evaluation of Phacogoniotomy in Medically-controlled POAG N/A
Recruiting NCT03369886 - The Relationship Between Macular OCTA and GCIPL and Their Combinational Index Using AI N/A
Active, not recruiting NCT04624698 - iStent Inject New Enrollment Post-Approval Study N/A
Recruiting NCT02679482 - Following Patients After Selective and Pascal Laser Trabeculoplasty for Treatment of Chronic Open-Angle Glaucoma N/A
Completed NCT02338362 - Inhaled Corticosteroids: Effect on Intraocular Pressure in Patients With Controlled Glaucoma Phase 4
Active, not recruiting NCT01430923 - Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost N/A
Completed NCT01489670 - Observational Study of Lumigan® 0.01% Treatment for Patients With Primary Open Angle Glaucoma or Ocular Hypertension N/A
Completed NCT00753168 - Phase 1-2 Evaluation of OT-730 Eye Drops in Reducing the Intraocular Pressure in Patients With Ocular Hypertension or Open-Angle Glaucoma Phase 1/Phase 2
Completed NCT00693485 - Safety and Effects of Brimonidine Intravitreal Implant in Patients With Glaucomatous Optic Neuropathy Phase 2
Completed NCT00051194 - A 6-week Safety & Efficacy Study of Combination Intraocular Pressure-lowering Therapy in Patients With Open-angle Glaucoma or Ocular Hypertension Phase 2
Recruiting NCT04920227 - Comparation of CLASS Combined With Phacoemulsification and CLASS Alone in the Treatment of Primary Open Angle Glaucoma N/A
Active, not recruiting NCT03868124 - Clinical Study Comparing Two Models of a Travoprost Intraocular Implant Phase 3
Completed NCT03267862 - Scleral Response to Intraocular Pressure (IOP) N/A
Recruiting NCT06066645 - Travoprost Intraocular Implant + iStent Infinite vs. iStent Infinite Alone Phase 3
Recruiting NCT04912362 - The Effectiveness of YAG Iridotomy in Preventing Peripheral Anterior Synechia After CLASS in Primary Open Angle Glaucoma N/A
Completed NCT04949802 - Glaucoma Surgery Using the ViaLase Laser System N/A
Recruiting NCT04038034 - Valuation of the Antioxidant and Neuroprotective Effects of CoQ10-MINIACTIVES® (COQUN® OS) in Patients Affected by Primary Open Angle Glaucoma N/A
Completed NCT04632329 - Negative Pressure Applied by the Equinox MPD for Severe Open Angle Glaucoma N/A
Completed NCT01215786 - Safety and Pharmacodynamics Study of AGN-207281 Ophthalmic Solutions Compared With Timolol Ophthalmic Solution or Placebo in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma Phase 1