CATS Tonometer IOP Reduction Latanoprost Verses Timolol

Glaucoma; Drugs Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04178863
• Other study ID #: 2019004
• Status: Recruiting
• Phase: Phase 4
• Start date: July 1, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: November 2019
• Source: Intuor Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 101 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma; Drugs

Intervention

Device:
• CATS Tonometer
latanoprost vs. timolol

Drug:
• Latanoprost
latanoprost IOP reduction

Locations

Country	Name	City	State
United States	Arizona Eye Consultants	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Intuor Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IOP reduction		1 month