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OpenTrials
Completed

NCT Number: NCT00576342

Patient Preference Study

In this randomized crossover study, patients will receive a single drop of two test articles and assess comfort.

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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 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Sign informed consent;
  • Diagnosis of glaucoma or ocular hypertension;
  • On a stable regimen of any intraocular pressure (IOP) lowering medication (mono-therapy);
  • IOP for which, in the opinion of the investigator, participation in the study does not present a risk to ocular health;
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Best corrected visual acuity worse than 0.60 logMAR (20/80 Snellen) in either eye;
  • Pregnant, nursing, or not using highly effective birth control methods;
  • Use of oral or topical corticosteroids within 30 days of the Screening Visit and during the course of the study;
  • History of bronchial asthma or severe chronic obstructive pulmonary disease;
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

AL-3862+timolol ophthalmic suspension

Drug

Dorzolamide+timolol ophthalmic solution

Drug

Other names: COSOPT

Primary outcomes

  1. Percentage of patients with a stated preference for either study medication

    Time frame: Day 2

Secondary outcomes

  1. Mean ocular discomfort score

    Time frame: Day 1, 1 minute after drop instillation

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

A Single Dose Patient Preference Study Comparison in Patients With Open-Angle Glaucoma or Ocular Hypertension

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 19, 2007
Registry last updated
Jul 11, 2014

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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