CATS Tonometer IOP Reduction Latanoprost Verses Timolol

November 23, 2019 updated by: Intuor Technologies, Inc.

Efficacy of Topical Latanoprost 0.005% Verses Timolol 0.5% Demonstrated by Corneal Biomechanical Correcting Modified Goldmann Prism

Topical Prostaglandin Analog vs Betablocker - Corneal Biomechanical Evaluation using CATS Tonometer Prism

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This clinical trial is a prospective, controlled, study and will be performed at one clinical investigative site in Tucson Arizona1. The purpose of this study is to determine if the device, CATS tonometer prism, measures intraocular pressure significantly differently than the current standard of care tonometer prism (Goldmann) before and after institution of topical prostaglandin analogs (PGA) for glaucoma treatment. Fifty percent of patients will be randomly placed on topical beta blockers as a control. The difference PGAs and beta blockers would be a measurement of the amount of corneal biomechanical changes made due to the PGA controlled for the effect of IOP lowering by the beta -blocker group.

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 101 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • • Male and female patients, at least 18 years of age

    • Subject has a clear understanding and agrees to all the conditions of the informed consent form

Exclusion Criteria:

  • Subjects shall be selected in accordance with the following exclusion criteria

    • Subject has undergone ocular surgery within the last 3 months
    • Uncontrolled systemic disease that in the opinion of the Investigator would put the subject's heath at risk
    • Pregnant or nursing women
    • Those who have had corneal surgery including corneal laser surgery
    • Microphthalmos
    • Buphthalmos
    • Severe Dry eyes
    • Lid squeezers - blepharospasm
    • Nystagmus
    • corneal or conjunctival infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: lataprost
latanoprost use
Device: CATS Tonometer
latanoprost vs. timolol
Other Names:
  • latanoprost v. timolol
Active Comparator: timolol
timolol group
Device: CATS Tonometer
latanoprost vs. timolol
Other Names:
  • latanoprost v. timolol
Drug: Latanoprost
latanoprost IOP reduction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
IOP reduction
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intuor Technologies, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Anticipated)

December 30, 2019

Study Completion (Anticipated)

December 30, 2019

Study Registration Dates

First Submitted

November 23, 2019

First Submitted That Met QC Criteria

November 23, 2019

First Posted (Actual)

November 26, 2019

Study Record Updates

Last Update Posted (Actual)

November 26, 2019

Last Update Submitted That Met QC Criteria

November 23, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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