Patients will receive a single drop of two test articles and assess their...
Date First Received: December 17, 2007
Last Updated: March 24, 2008
Verified by: Alcon Research, March 2008
Clinical Trial Phase: Phase 3 | Start Date: November 2007
Overall Status: Completed
Estimated Enrollment: 115
Brief Summary
Official Title: “A Single Dose Patient Preference Study Comparison in Patients With Open-Angle Glaucoma or Ocular Hypertension”
Condition Keyword(s):
Intervention(s):
Patients will receive a single drop of two test articles and assess their comfort
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Crossover Assignment, Safety Study
Study Primary Completion Date: March 2008
Intervention(s) in this Clinical Trial
- Drug: AL-3862 + Timolol
- Dosage of drug
- Drug: Timolol
- Timolol drops as needed
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- Experimental: 2
Outcome Measures for this Clinical Trial
Primary Measures
- Patient Preference
- Time Frame: 2 min
Safety Issue?: No
- Time Frame: 2 min
Secondary Measures
- Comfort/discomfort of medication after dosing with one drop
- Time Frame: 2
Safety Issue?: No
- Time Frame: 2
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Glaucoma or ocular hypertension
- No corticosteroid use within 30 days
- No antihistamine or analgesic drug use
- No artificial tear use within 3 days
- No concurrent conjunctivitis, keratitis, scleritis or uveitis
Exclusion Criteria:
- History of bronchial asthma or severe chronic obstructive pulmonary disease
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Alcon Research
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00576342
Study ID Number: C-07-47
ClinicalTrials.gov Identifier: NCT00576342
Health Authority: United States: Food and Drug Administration
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