CATS Tonometer IOP Reduction Latanoprost Verses Timolol

NCT ID: NCT04178863

Last Updated: 2019-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2019-12-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Glaucoma; Drugs

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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lataprost

latanoprost use

Group Type ACTIVE_COMPARATOR

CATS Tonometer

Intervention Type DEVICE

latanoprost vs. timolol

timolol

timolol group

Group Type ACTIVE_COMPARATOR

CATS Tonometer

Intervention Type DEVICE

latanoprost vs. timolol

Latanoprost

Intervention Type DRUG

latanoprost IOP reduction

Interventions

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CATS Tonometer

latanoprost vs. timolol

Intervention Type DEVICE

Latanoprost

latanoprost IOP reduction

Intervention Type DRUG

Other Intervention Names

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latanoprost v. timolol

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

101 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Intuor Technologies, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Arizona Eye Consultants

Tucson, Arizona, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Sean McCafferty, MD

Role: primary

520-400-4255

References

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Radcliffe N, Berdahl J, Ibach M, Schweitzer J, Levine J, McCafferty S. Improved Efficacy of Topical Latanoprost 0.005% Demonstrated by Corneal Biomechanical Correcting Modified Goldmann Prism. Clin Ophthalmol. 2020 Aug 10;14:2245-2253. doi: 10.2147/OPTH.S264055. eCollection 2020.

Reference Type DERIVED
PMID: 32884231 (View on PubMed)

Other Identifiers

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2019004

Identifier Type: -

Identifier Source: org_study_id

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