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CATS Tonometer IOP Reduction Latanoprost Verses Timolol

Sponsor
Intuor Technologies, Inc. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT04178863
Collaborator
(none)
72
Enrollment
1
Location
2
Arms
18
Anticipated Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Efficacy of Topical Latanoprost 0.005% Verses Timolol 0.5% Demonstrated by Corneal Biomechanical Correcting Modified Goldmann Prism
Actual Study Start Date :
Jul 1, 2018
Anticipated Primary Completion Date :
Dec 30, 2019
Anticipated Study Completion Date :
Dec 30, 2019

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. IOP reduction [1 month]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 101 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona Eye Consultants Tucson Arizona United States 85710

    Sponsors and Collaborators

    • Intuor Technologies, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Intuor Technologies, Inc.
    ClinicalTrials.gov Identifier:
    NCT04178863
    Other Study ID Numbers:
    • 2019004
    First Posted:
    Nov 26, 2019
    Last Update Posted:
    Nov 26, 2019
    Last Verified:
    Nov 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Additional relevant MeSH terms:
    Glaucoma
    Timolol
    Latanoprost

    Study Results

    No Results Posted as of Nov 26, 2019