Back to resultsCATS Tonometer IOP Reduction Latanoprost Verses Timolol
Primary Purpose
Glaucoma; Drugs
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
CATS Tonometer
Latanoprost
Sponsored by
About this trial
This is an interventional diagnostic trial for Glaucoma; Drugs
Eligibility Criteria
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.
Sites / Locations
- Arizona Eye ConsultantsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
lataprost
timolol
Arm Description
latanoprost use
timolol group
Outcomes
Primary Outcome Measures
IOP reduction
Secondary Outcome Measures
Full Information
NCT ID
NCT04178863
First Posted
November 23, 2019
Last Updated
November 23, 2019
Sponsor
Intuor Technologies, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04178863
Brief Title
CATS Tonometer IOP Reduction Latanoprost Verses Timolol
Official Title
Efficacy of Topical Latanoprost 0.005% Verses Timolol 0.5% Demonstrated by Corneal Biomechanical Correcting Modified Goldmann Prism
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
December 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intuor Technologies, Inc.
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Topical Prostaglandin Analog vs Betablocker - Corneal Biomechanical Evaluation using CATS Tonometer Prism
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma; Drugs
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
lataprost
Arm Type
Active Comparator
Arm Description
latanoprost use
Arm Title
timolol
Arm Type
Active Comparator
Arm Description
timolol group
Intervention Type
Device
Intervention Name(s)
CATS Tonometer
Other Intervention Name(s)
latanoprost v. timolol
Intervention Description
latanoprost vs. timolol
Intervention Type
Drug
Intervention Name(s)
Latanoprost
Intervention Description
latanoprost IOP reduction
Primary Outcome Measure Information:
Title
IOP reduction
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
101 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Arizona Eye Consultants
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sean McCafferty, MD
Phone
520-400-4255
Email
sjmccafferty66@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32884231
Citation
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.
Results Reference
derived
Learn more about this trial
CATS Tonometer IOP Reduction Latanoprost Verses Timolol
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