Pressure Reduction Effect in Patients With Glaucoma Who Used Xalatan and Cosopt - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00766922

Purpose

evaluate the tolerability and the pressure reduction effect obtained by association of Cosopt in patients who present a 15% intra-ocular reduction after being treated with monotherapy (Xalatan) and need an additional pressure reduction based on clinical parameters.

Condition	Intervention	Phase
Glaucoma	Drug: dorzolamide hydrochloride (+) timolol maleate (Cosopt) Drug: Comparator: latanoprost (Xalatan)	Phase III

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Latanoprost Dorzolamide Dorzolamide hydrochloride Timolol Timolol maleate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Additional Pressure Reduction Effect by Association of Timolol 0.5%/Dorzolamide 2% (Cosopt) to Monotherapy With Latanoprost (Xalatan) in Patients With High Intra-Ocular Pressure

Further study details as provided by Merck:

Primary Outcome Measures:

study to compare the reduction effect of the intra-ocular pressure obtained by adding dorzolamide 2%/timolol 0.5% to monotherapy treatment with latanoprost and verify the ophthalmic adverse events [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	49
Study Start Date:	June 2007
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental latanoprost	Drug: Comparator: latanoprost (Xalatan) One drop latanoprost in each eye once daily for 15 days (visit - 15 days). If patient needs an additional pressure reduction, he/she will continue to receive 30 days treatment with latanoprost in both eyes.
2: Experimental latanoprost and dorzolamide (+) timolol	Drug: dorzolamide hydrochloride (+) timolol maleate (Cosopt) Patients requiring additional pressure reduction after the study visit on Day 15 will be given one drop dorzolamide (+) timolol twice daily for 30 days in one eye only in addition to latanoprost in both eyes.

Eligibility

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

Criteria

Inclusion Criteria:

> 18 Years Old With Glaucoma
Reduction Of 15% At Least After Latanoprost Treatment

Exclusion Criteria:

Women With Potential To Become Pregnant And Who Do Not Use Contraceptives.
Pregnancy
Breastfeeding
Ophthalmology Surgery, Inflammation/Infection in the last 3 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00766922

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

PhRMA Clinical Study Results Database - web-based repository for clinical study results This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_556, MK0507A-154
Study First Received:	October 3, 2008
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00766922
Health Authority:	Brazil: Ministry of Health

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Timolol
Latanoprost

Dorzolamide
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents

Pharmacologic Actions
Carbonic Anhydrase Inhibitors
Therapeutic Uses
Adrenergic beta-Antagonists
Adrenergic Antagonists
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on January 16, 2009