Safety and IOP Lowering Efficacy of AL-6221 - Full Text View

Sponsored by:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00637130

Purpose

The purpose of this study is to compare the safety and IOP-lowering efficacy of various AL-6221 formulations in patients with open-angle glaucoma or ocular hypertension

Condition	Intervention	Phase
Open-Angle Glaucoma Ocular Hypertension	Drug: AL-6221 Drug: TRAVATAN QD Drug: Placebo	Phase II

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Travoprost

U.S. FDA Resources

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

Further study details as provided by Alcon Research:

Primary Outcome Measures:

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

Estimated Enrollment:	125
Study Start Date:	October 2007
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental AL-6221 0.0008% BID	Drug: AL-6221 Comparison of safety and IOP lowering efficacy of different concentrations of AL-6221 with that of TRAVATAN
2: Experimental AL-6221 0.001% BID	Drug: AL-6221 Comparison of safety and IOP lowering efficacy of different concentrations of AL-6221 with that of TRAVATAN
3: Experimental AL-6221 0.0012% BID	Drug: AL-6221 Comparison of safety and IOP lowering efficacy of different concentrations of AL-6221 with that of TRAVATAN
4: Active Comparator TRAVATAN QD	Drug: TRAVATAN QD Comparison of safety and IOP lowering efficacy of different concentrations of TRAVATAN with that of AL-6221
5: Placebo Comparator Vehicle	Drug: Placebo Vehicle

Eligibility

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

Criteria

Inclusion Criteria:

Patients 18 years of age or older, either sex or race with open-angle glaucoma or confirmed ocular hypertension

Exclusion Criteria:

Age related

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637130

Locations

United States, California
Artesia
Artesia, California, United States, 90701

Sponsors and Collaborators

Alcon Research

More Information

No publications provided

Responsible Party:	Alcon ( Theresa Landry )
Study ID Numbers:	C-06-11
Study First Received:	February 29, 2008
Last Updated:	July 28, 2008
ClinicalTrials.gov Identifier:	NCT00637130 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Vascular Diseases
Cardiovascular Agents

Antihypertensive Agents
Travoprost
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Glaucoma
Therapeutic Uses
Eye Diseases
Glaucoma, Open-Angle
Vascular Diseases
Cardiovascular Diseases

Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Travoprost
Ocular Hypertension
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009