Patient Preference Study

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00576342
• Other study ID #: C-07-47
• Status: Completed
• Phase: Phase 3
• First received: December 17, 2007
• Last updated: July 9, 2014
• Start date: December 2007
• Est. completion date: January 2008

Study information

• Verified date: July 2014
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• AL-3862+timolol ophthalmic suspension

• Dorzolamide+timolol ophthalmic solution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with a stated preference for either study medication		Day 2	No
Secondary	Mean ocular discomfort score		Day 1, 1 minute after drop instillation	No