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OpenTrials
Completed

NCT Number: NCT00486252

Non Interventional Study in Patients With Open Angle Glaucoma and/or Ocular Hypertension Treated With XALATAN®

The primary objective is to evaluate the Intraocular pressure reducing effect of Xalatan over 3 months. The secondary objective is to study the other efficacy parameters during treatment for 3 months

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Key information

Conditions

Glaucoma,Open-Angle Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Unilateral or bilateral open angle glaucoma or ocular hypertension (IOP (Intraocular Pressure) ≥ 21 mmHg at diagnosis).
  • Naive patients (no prior anti-glaucoma pharmacological or surgical treatment) and patients with beta-blockers therapy failure
  • Visual acuity (best corrected) equal to or better than 6/6

Exclusion criteria

  • closed/barely open anterior chamber angle or history of acute angle closure glaucoma.
  • history of any antiglaucoma surgical treatment (Argon Laser Trabeculoplasty and/or any ocular filtering surgical intervention).
  • ocular surgery (on the globe of the eye only), or inflammation/infection within 3 months prior to baseline visit. (Applies to both fellow and study eyes.)
  • other abnormal ocular conditions or symptoms preventing the patient from entering the study, in the investigator's clinical judgement.

Treatment and study plan

Observational

Other

This is a non-interventional study. Subgroups of naïve patients and patients with previous failure to beta-blockers therapy were analyzed.

Primary outcomes

  1. Change in Intraocular Pressure (IOP): Baseline to Month 3

    Time frame: Baseline, Month 3

    Change: IOP at observation minus IOP at baseline. IOP was measured with the non-contact or Goldmann tonometer for a given subject. Three measurements were performed in each eye alternating between the eyes, starting with the right eye. The mean of the 3 measurements was used and if both eyes were study eyes, the mean of the 2 eyes was used.

Secondary outcomes

  1. Percentage Change in Intraocular Pressure (IOP)

    Time frame: Month 1, Month 3

    Percentage change in IOP calculated as 100 times (IOP at Observation minus IOP at Baseline) divided by IOP at Baseline.

  2. Categorized Percentage Change in Intraocular Pressure (IOP)

    Time frame: Month 1, Month 3

    Percentage change=100 times (IOP at observation minus IOP at Baseline) divided by IOP at Baseline. Percentage change in each patient assigned to the following: Increase or no change in IOP (percentage change greater than or equal to 0); Percentage reduction of up to 20% (-20 less than or equal to percentage change < 0); Percentage reduction greater than 20% (percentage change < -20).

Other outcomes

  1. Change in Intraocular Presssure (IOP): Baseline to Month 1

    Time frame: Baseline, Month 1

    Change: IOP at observation minus IOP at baseline. IOP was measured with the non-contact or Goldmann tonometer for a given subject. Three measurements were performed in each eye alternating between eyes, starting with the right eye. The mean of the 3 measurements was used and if both eyes were study eyes, the mean of the 2 eyes was used.

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study title

Non Interventional Study in Patients With Open Angle Glaucoma and/or Ocular Hypertension Treated With XALATAN® (Latanoprost) as First-Line Monotherapy and as Second-Line Monotherapy After Beta-Blockers Therapy Failure

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 14, 2007
Registry last updated
Mar 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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