Adjunctive Study of AL-37807 Ophthalmic Suspension - Full Text View

Sponsored by:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00620256

Purpose

The purpose of the study is to compare the safety and IOP-lowering efficacy of AL-37807, 1% vs. Timolol Gel Forming Solution, 0.5% vs. Vehicle all dosed QD AM, all dosed concomitantly with Xalatan QD PM in patients with open-angle glaucoma or ocular hypertension

Condition	Intervention	Phase
Open-Angle Glaucoma Ocular Hypertension	Drug: AL-37807	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Mean IOP change from baseline [ Time Frame: from baseline ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	November 2007
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental AL-37807	Drug: AL-37807 Active drug
2: Active Comparator Timolol Gel Forming Solution	Drug: AL-37807 Active drug
3: Placebo Comparator Vehicle	Drug: AL-37807 Active drug

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

open-angle glaucoma
ocular hypertension
Must have been on Xalatan for at least 3 months
VA not worse than 0.60

Exclusion Criteria:

Age related

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00620256

Locations

United States, Texas
San Antonio
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Alcon Research

More Information

No publications provided

Responsible Party:	Alcon ( Theresa Landry )
Study ID Numbers:	C-07-05
Study First Received:	February 11, 2008
Last Updated:	August 26, 2008
ClinicalTrials.gov Identifier:	NCT00620256 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alcon Research:

Glaucoma
hypertension

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Vascular Diseases

Timolol
Latanoprost
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Vascular Diseases

Cardiovascular Diseases
Ocular Hypertension
Hypertension

ClinicalTrials.gov processed this record on September 04, 2009