Adherence With Fixed Versus Unfixed Glaucoma Therapy | NCT01281020

Studies
Adherence With Fixed Versus Unfixed Glaucoma Therapy

NCT01281020

Sponsor

Aristotle University Of Thessaloniki

Status

Completed

Last Update Posted

Dec 17, 2020Actual

Enrollment

132Actual

Phase

Not provided

Conditions

Primary Open-angle Glaucoma
Ocular Hypertension
Exfoliation Glaucoma

Interventions

Not provided

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009Actual

Primary Completion Date

Jun 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

Jan 20, 2011

First Submission Date that Met QC Criteria

Jan 20, 2011

First Posted Date

Jan 21, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2020

Last Update Posted Date

Dec 17, 2020Actual

Name	Class
Pfizer	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A 6-month, parallel, non-interventional trial investigating the level of adherence and the impact of dosing in open-angle glaucoma patients who receive either unfixed therapy with latanoprost once in the evening and timolol twice daily, or latanoprost/timolol fixed combination therapy once in the evening. All patients participating in this observational study will be monitored for their adherence with the use of Medication Event Monitoring System (MEMS). At the end of treatment periods treatment satisfaction will be assessed with selected questions from the Treatment Satisfaction Survey-Intraocular Pressure survey. This study will monitor objectively, for the first time, adherence and intraocular pressure control with fixed versus unfixed therapy. Finally it will help us to elucidate the impact of dosing (once-a-day versus three-times-daily) on the level of adherence in glaucoma.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

132Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment with fixed combination		Patients who receive treatment with latanoprost/timolol fixed combination
Treatment with unfixed therapy		Patients who receive latanoprost and timolol therapy

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of adherence	Rate of asherence with fixed vs unfixed glaucoma therapy	6 months

Secondary Outcomes

Measure	Description	Time Frame
Ocular surface evaluation	Objective and subjective signs of ocular surface health	6 months
Treatment satisfaction	To document satisfaction with therapy this study will employ questions selected from a validated treatment satisfaction questionnaire (questions 10-15, Treatment Satisfaction Survey-Intraocular Pressure) as published by Day et al (Eye 2006; 20: 583-590). The survey will assess the level of satisfaction and overall quality-of-life with latanoprost/timolol fixed combination versus unfixed therapy in this study.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient is between 21-80 years old
Patient has ocular hypertension or open-angle glaucoma Patient receives therapy and is well controlled on fixed or unfixed latanoprost and timolol therapy
Untreated IOP >19 mm Hg <33 mm Hg at baseline (10:00 hour)
Open normal appearing angles
Patient had at least a 20% reduction vs untreated baseline on current therapy
Patient has early or moderate glaucoma (< 14 decibel; 0.8 or better cupping)
Distance best corrected Snellen visual acuity greater than 1/10

Exclusion Criteria:

Contraindication to timolol or prostaglandin therapy
History of lack of response to any medication (< 10%)
Patient does not understand the instructions and will not comply to medications
Patient can not attend follow up
Patient is a female of childbearing potential, or lactating mother
History of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses
Sign of ocular infection
A corneal abnormality that may affect IOP measurements

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

All patients who use latanoprost/timolol fixed combination therapy with once-a-day dosing in the evening

All patients already treated with timolol twice daily and latanoprost once in the evening

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anastasios G Konstas, MD, PhD	Glaucoma Unit, 1st University Department of Ophthalmology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Glaucoma Unit, 1st University Department of Ophthalmology, AHEPA Hospital		Thessaloniki		546 36	Greece

Condition Browse Module

MeSH Terms

ID	Term
D005902	Glaucoma, Open-Angle
D009798	Ocular Hypertension
D017889	Exfoliation Syndrome
D005901	Glaucoma

Ancestor Terms

ID	Term
D005128	Eye Diseases
D007499	Iris Diseases
D014603	Uveal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided