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OpenTrials
Completed

NCT Number: NCT05451329

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

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.

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Key information

Conditions

Glaucoma, Open-Angle Eye Diseases Glaucoma Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Lexitas

Durham, North Carolina, 27701, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VVN539 Ophthalmic Solution 0.02%

Drug

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%

Drug

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

Drug

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

Primary outcomes

  1. Mean Intraocular Pressure

    Time frame: 8AM, 10AM, and 4PM at Day 7; Day 14 and Day 21

    mmHg

Secondary outcomes

  1. Mean Change in Intraocular Pressure From Baseline

    Time frame: 8AM, 10AM, and 4PM at Day 7; Day 14 and Day 21

    mmHg

Sponsors and collaborators

Lead sponsor

VivaVision Biotech, Inc

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 11, 2022
Registry last updated
Jan 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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