Adherence With Fixed Versus Unfixed Glaucoma Therapy

NCT01281020

Last updated date
Study Location
Glaucoma Unit, 1st University Department of Ophthalmology, AHEPA Hospital
Thessaloniki, , 546 36, Greece
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Primary Open-angle Glaucoma, Ocular Hypertension, Exfoliation Glaucoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Primary Open-angle Glaucoma, Ocular Hypertension, Exfoliation GlaucomaAdherence With Fixed Versus Unfixed Glaucoma Therapy
NCT01281020
  1. Thessaloniki,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Adherence With Fixed Versus Unfixed Glaucoma Therapy
Official Title A 3-month, Observational Study Investigating With Electronic Monitoring the Level of Adherence and Treatment Satisfaction With Latanoprost/Timolol Fixed Combination Versus Unfixed Therapy in Open-angle Glaucoma
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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
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

Condition
  • Primary Open-angle Glaucoma
  • Ocular Hypertension
  • Exfoliation Glaucoma
Intervention Not Provided
Study Groups/Cohorts
  • Treatment with fixed combination
    Patients who receive treatment with latanoprost/timolol fixed combination
  • Treatment with unfixed therapy
    Patients who receive latanoprost and timolol therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 26, 2011)
132
Original Estimated Enrollment
 (submitted: January 20, 2011)
120
Actual Study Completion Date July 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Greece
Removed Location Countries  
 
Administrative Information
NCT Number NCT01281020
Other Study ID Numbers NIS50/01/08
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party AGP Konstas, Aristotle University Of Thessaloniki
Study Sponsor Aristotle University Of Thessaloniki
Collaborators Pfizer
Investigators
Principal Investigator:Anastasios G Konstas, MD, PhDGlaucoma Unit, 1st University Department of Ophthalmology
PRS Account Aristotle University Of Thessaloniki
Verification Date December 2020