Adjunctive Study of AL-37807 Ophthalmic Suspension

Ocular Hypertension Clinical Trial

Official title:

Comparison of Safety and Efficacy of Al-37807 Ophthalmic Suspension vs. Timolol Gel Forming Solution and Vehicle, All Dosed Concomitantly With Xalatan in Patients With Open-Angle Glaucoma or Ocular Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00620256
• Other study ID #: C-07-05
• Status: Completed
• Phase: Phase 2
• First received: February 11, 2008
• Last updated: December 3, 2012
• Start date: November 2007
• Est. completion date: July 2008

Study information

• Verified date: December 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to compare the safety and intraocular pressure-lowering efficacy of AL-37807 ophthalmic suspension vs. Timolol gel forming solution vs. AL-37807 vehicle, all dosed concomitantly with Xalatan, in patients with open-angle glaucoma or ocular hypertension.

Recruitment information / eligibility

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

Eligibility

Inclusion Criteria:

• Open-angle glaucoma

• Ocular hypertension

• Must have been on Xalatan for at least 3 months

• VA not worse than 0.60

• Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

• Age related

• Other protocol-defined exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open-Angle Glaucoma

Intervention

Drug:
• AL-37807 ophthalmic suspension, 0.1%

• Timolol gel forming solution, 0.5%

Other:
• AL-37807 ophthalmic solution vehicle

Drug:
• Latanoprost ophthalmic solution

Locations

Country	Name	City	State
United States	Contact Alcon Call Center at 1-888-451-3937	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in intraocular pressure		Baseline, up to 4 weeks	No