Clinical Trials Logo
  1. Home
  2. Ocular Hypertension
  3. NCT01943721
  4. Details
NCT01943721 Clinical Trial

A Study of the VISION5 Product in Patients With Glaucoma or Ocular Hypertension

Ocular Hypertension Clinical Trial

Official title:
A Study of the VISION5 Product in Patients With Glaucoma or Ocular Hypertension

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01943721
Other study ID # ForSight VISION5 Study 504
Secondary ID
Status Completed
Phase Phase 1
First received September 10, 2013
Last updated December 15, 2014
Start date October 2013
Est. completion date June 2014

Study information
Verified date December 2014
Source ForSight Vision5, Inc.
Contact n/a
Is FDA regulated No
Health authority Latvia: Institutional Review BoardLatvia: State Agency of Medicines
Study type Interventional

Clinical Trial Summary

The objective of this Phase 1 study is to evaluate the VISION5 Product's safety and efficacy.

Recruitment information / eligibility
Status Completed
Enrollment 14
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Written informed consent

- Primary open-angle glaucoma or ocular hypertension in both eyes

- Best-corrected distance vision of 20/100 or better

- Stable visual field

Exclusion Criteria:

- Cup-to-disc ratio greater than 0.8

- Laser surgery for glaucoma/ocular hypertension on one or both eyes within the last 12 months

- Corneal refractive surgery within prior 6 months

- Past history of any incisional surgery for glaucoma at any time

- Corneal abnormalities that would interfere with tonometry readings

- Current participation in an investigational drug or device study or participation in such a study within 30 days of screening

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• VISION5 Product

Locations
Country Name City State
Latvia Contact ForSight VISION5 for Trial Locations Contact ForSight VISION5 for Trial Locations

Sponsors (1)
Lead Sponsor Collaborator
ForSight Vision5, Inc.

Country where clinical trial is conducted

Latvia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ocular Tonometry (change from baseline) Week 2, 6, 12 and Months 4,5,6 No
Secondary Safety as assessed by Slit Lamp Exam Weeks 2,6,12 and Months 4,5,6 Yes
See also
  Status Clinical Trial Phase
Completed NCT03284853 - Safety and Efficacy Study of PG324 (Netarsudil/Latanoprost 0.02% / 0.005%) Ophthalmic Solution Compared to GANFORT® Ophthalmic Solution in Open Angle Glaucoma or Ocular Hypertension Phase 3
Completed NCT01157364 - Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension Phase 1/Phase 2
Not yet recruiting NCT06441643 - Next Generation Rocklatan Phase 2
Recruiting NCT02471105 - Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml Phase 4
Recruiting NCT02792803 - A Comparison of Xalatan (Latanoprost) to Apo-latanoprost and Co-latanoprost in the Treatment of Glaucoma Phase 4
Terminated NCT02801617 - Non-inferiority of PRO-067 Ophthalmic Solution vs GAAP Ofteno® in Glaucoma or Ocular Hypertension Phase 3
Completed NCT02558374 - Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension Phase 3
Completed NCT02628223 - 180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma N/A
Completed NCT02993445 - Effect of Alternate Therapies on Intraocular Pressure in Ocular Hypertension N/A
Completed NCT02246764 - Study of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension Phase 3
Completed NCT02338362 - Inhaled Corticosteroids: Effect on Intraocular Pressure in Patients With Controlled Glaucoma Phase 4
Completed NCT02390245 - Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study N/A
Completed NCT01936389 - A Prospective Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Exfoliation Syndrome and Ocular Hypertension or Glaucoma Phase 2
Completed NCT02003547 - A Single Centre Study to Evaluate 3 Ophthalmic Formulations in Healthy Subjects Phase 1
Completed NCT01995136 - Investigation of Intraocular Pressure (IOP) Reduction Efficacy of Travoprost Ophthalmic Solution in Patients With Normal Tension Glaucoma Phase 4
Completed NCT01664039 - An Efficacy and Tolerability Study of TRAVATAN® Versus LUMIGAN® Phase 4
Completed NCT01693315 - Multiple Dose-escalation Study of AMA0076 in Patients With Ocular Hypertension or Primary Open-angle Glaucoma Phase 2
Active, not recruiting NCT01430923 - Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost N/A
Completed NCT01340014 - Patient Preference Comparison of AZARGA Versus COSOPT Phase 4
Completed NCT01489670 - Observational Study of Lumigan® 0.01% Treatment for Patients With Primary Open Angle Glaucoma or Ocular Hypertension N/A