Clinical Trials Logo
  1. Home
  2. Glaucoma, Open-Angle
  3. NCT05451329
  4. Details
NCT05451329 Clinical Trial

A Phase 2 Double-masked Study of VVN539 in Subjects With Elevated Intraocular Pressure

Glaucoma, Open-Angle Clinical Trial

Official title:
A Phase 2, Double-masked, Randomized, Vehicle-controlled, Dose-response Study Assessing the Safety and Ocular Hypotensive Efficacy of VVN539 in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05451329
Other study ID # VVN539-CS-201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date July 12, 2022
Est. completion date December 22, 2022

Study information
Verified date December 2023
Source VivaVision Biotech, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a prospective, parallel-comparison, multi-center, double-masked, randomized, vehicle-controlled dose-response study assessing the safety and ocular hypotensive efficacy of VVN539 in subjects with POAG or OHT. Three different dosing regimens (once a day [q.d.] in the morning, q.d. in the evening and twice a day [b.i.d.]) will be tested for 7-9 days, each.

Recruitment information / eligibility
Status Completed
Enrollment 68
Est. completion date December 22, 2022
Est. primary completion date December 22, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years of age or older. - Diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes that are untreated, or if treated, in the opinion of the investigator are well controlled on 2 or fewer ocular hypotensive medications prior to Visit 1. - Unmedicated intraocular pressure of = 22 mm Hg and = 36 mm Hg in the study eye, with no more than 5 mm Hg inter-eye difference at 08:00AM and 10:00AM at Visit 2. - Corrected visual acuity in each eye +1.0 or better by Early Treatment Diabetic Retinopathy Scale in each eye (equivalent to Snellen 20/200) Exclusion Criteria: - Known hypersensitivity to any kinase inhibitors, any excipient or preservative of the formulation or to topical anesthetics or fluorescein. - Unmedicated IOP of > 36 mm Hg in either eye at any time point at Visit 2.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• VVN539 Ophthalmic Solution 0.02%
Once a day [q.d.] in the morning, q.d. in the evening and twice a day [b.i.d.]) will be tested for 7-9 days
• VVN539 Ophthalmic Solution 0.04%
Once a day [q.d.] in the morning, q.d. in the evening and twice a day [b.i.d.]) will be tested for 7-9 days
• VVN539 Ophthalmic Solution Vehicle
Once a day [q.d.] in the morning, q.d. in the evening and twice a day [b.i.d.]) will be tested for 7-9 days

Locations
Country Name City State
United States Lexitas Durham North Carolina

Sponsors (1)
Lead Sponsor Collaborator
VivaVision Biotech, Inc

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean Intraocular Pressure mmHg 8AM, 10AM, and 4PM at Day 7; Day 14 and Day 21
Secondary Mean Change in Intraocular Pressure From Baseline mmHg 8AM, 10AM, and 4PM at Day 7; Day 14 and Day 21
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 NCT00693485 - Safety and Effects of Brimonidine Intravitreal Implant in Patients With Glaucomatous Optic Neuropathy Phase 2
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 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