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OpenTrials
Completed

NCT Number: NCT00143208

Evaluation Of Intraocular Pressure Lowering-Effect Of Xalacom In Patients With Poag Or Oh.

This study is designed as an open label evaluation of the efficacy of latanoprost and timolol fixed combination (Xalacom) after 6 month of treatment. Eligible patients may be enrolled at the baseline visit. All current ocular hypotensive therapy must be discontinued at this time. On baseline day, patients eligible for the study will receive Xalacom which is to be instilled in the morning.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Arezzo, Italy

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of glaucoma (primary open angle, pigmentary, exfoliative) or ocular hypertension (IOP >= 21 mmHG).
  • Visual acuity >= 20/200.

Exclusion criteria

  • Closed/barely open anterior chamber angle or history of acute angle closure glaucoma.
  • Hystory of ALT within 3 months prior to the baseline visit.
  • History of any ocular filtering surgical intervention.
  • Ocular surgery or inflammation/infection within 3 months prior to the baseline visit.

Treatment and study plan

Xalacom

Drug

Primary outcomes

  1. IOP change from baseline to the 6-month visit.

Secondary outcomes

  1. % reduction of IOP change from baseline to the 6-month visit.

  2. Proportion of pts achieving different levels of mean % of IOP reduction at the end of the treatment(eg:0%,10%,15%,20%,etc).

  3. Proportion of pts who reach specific IOP levels at the end of treatment(eg:16,17,18,19 mmHg,etc).

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

Evaluation Of Intraocular Pressure Lowering-Effect Of Xalacom (Fixed Combination Of Latanoprost And Timolol) In Patients With Poag Or Oh. A 6-Month, Open, Multi-Center Trial In Italy

Important dates

Study start
2003
Study completion
2006
First posted
Sep 2, 2005
Registry last updated
Feb 21, 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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