NCT04178863

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 26, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

November 26, 2019

Status Verified

November 1, 2019

Enrollment Period

1.5 years

First QC Date

November 23, 2019

Last Update Submit

November 23, 2019

Conditions

Glaucoma; Drugs

Outcome Measures

Primary Outcomes (1)

  • IOP reduction

    1 month

Study Arms (2)

lataprost

ACTIVE COMPARATOR

latanoprost use

Device: CATS Tonometer

timolol

ACTIVE COMPARATOR

timolol group

Device: CATS TonometerDrug: Latanoprost

Interventions

CATS TonometerDEVICE

latanoprost vs. timolol

Also known as: latanoprost v. timolol
lataprosttimolol
LatanoprostDRUG

latanoprost IOP reduction

timolol

Eligibility Criteria

Age18 Years - 101 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona Eye Consultants

Tucson, Arizona, 85710, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32884231DERIVED

MeSH Terms

Conditions

Glaucoma

Interventions

Latanoprost

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2019

First Posted

November 26, 2019

Study Start

July 1, 2018

Primary Completion

December 30, 2019

Study Completion

December 30, 2019

Last Updated

November 26, 2019

Record last verified: 2019-11

Locations

US(1)