A Study to Evaluate the Effectiveness of Cosopt® as First Line Therapy (MK-0507A-153)

Glaucoma Clinical Trial

Official title:

A 12 Week, Open-Label, Study to Evaluate the Effectiveness of Dorzolamide-Timolol as First Line Therapy to Reduce Intraocular Pressure in Patients With Untreated Open Angle Glaucoma (OAG) or Ocular Hypertension (OH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00546286
• Other study ID #: 0507A-153
• Secondary ID: MK0507A-1532007_
• Status: Completed
• Phase: Phase 3
• First received: October 16, 2007
• Last updated: March 31, 2017
• Start date: May 31, 2006
• Est. completion date: August 23, 2007

Study information

• Verified date: March 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluate the effectiveness of dorzolamide-timolol (Cosopt®) as first line therapy in reducing intraocular pressure in patients with untreated Open angle glaucoma (OAG) or Ocular hypertension (OH).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: August 23, 2007
• Est. primary completion date: August 23, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient has been recently diagnosed and is presently untreated for Open-Angle Glaucoma Or Ocular Hypertension With An iop of at least 27 mmhg in at least one eye (patient's worse eye)

• Patient Already Diagnosed With Open-Angle Glaucoma Or Ocular Hypertension And Untreated For At Least 30 Days Are Eligible For The Study If They Have An Iop Of 27 Mmhg Or More In At Least One Eye

Exclusion Criteria:

• A History Of Any Illness That, In The Opinion Of The Investigator, Might Confound The Results Of The Study Or Pose Additional Risk By Administering Dorzolamide-Timolol (Cosopt®) Or Prostaglandins

• The Presence Of Any Fundus Pathology Likely To Change During The Study Or To Influence Iop (Background Of Diabetic Retinopathy Is Permitted)

• Any Contraindication To The Use Of Cosopt® Including: - Bronchospasm, Including Bronchial Asthma Or A History Of Bronchial Asthma Or Chronic Obstructive Pulmonary Disease. - Sinus Bradycardia, Second Or Third Degree Av Block, Cardiac Failure (Grade Iii And Iv), Cardiogenic Shock

• Patient On Oral Carbonic Anhydrase Inhibitor, Concomitant Systemic Or Dermatological Medication Known To Affect The Iop, E.G. Clonidine, Corticosteroids, Oral Beta-Blocking Agents

• Pregnant Woman Or A Woman Of Childbearing Potential Who Is Sexually Active And Not Using An Acceptable Method Of Contraception (For Ex: Oral Contraceptive, Diaphragm, Contraceptive Sponge, Intra-Uterine Device, Long-Acting Contraceptive Injections, Double-Barrier Methods) Beginning At Least 7 Days Prior To Treatment And Continuing At Least 14 Days After The Last Visit Or The Discontinuation Visit. (Women Who Are Postmenopausal Or Have Received A Hysterectomy Or Have Undergone Tubal Ligature Are Considered As Not Having Childbearing Potential.)

• Severe Renal Impairment (Serum Creatinine > 150 umol/L Or Creatinine Clearance < 30 ml/min)

Related Conditions & MeSH terms

• Glaucoma
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• dorzolamide hydrochloride (+) timolol maleate
Combination treatment of dorzolamide HCl (2%)/ timolol maleate (0.5%) BID for six weeks in patients with open-angle glaucoma or ocular hypertension. For patients who achieve target IOP at 6 weeks, dorzolamide/timolol is continued for another 6 weeks.
• Comparator: dorzolamide HCl/timolol maleate + prostaglandin
Combination treatment of dorzolamide HCl (2%)/timolol maleate(0.5%) BID for six weeks in patients with open-angle glaucoma or ocular hypertension. For patients not achieving target IOP at 6 weeks, a prostaglandin is added for another 6 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Crichton AC, Harasymowycz P, Hutnik CM, Behki R, Boucher S, Ibrahim F, Rifkind AW, Solomon L, Liao C, Bastien NR, Sampalis JS. Effectiveness of dorzolamide–timolol (COSOPT) in patients who were treatment naive for open-angle glaucoma or ocular hypertensio — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in IOP 4 mmHg (or >= 20%) over a period of 6 or 12 weeks.		6 to 12 weeks

External Links

•   MedWatch - FDA maintained medical product safety Information
•   Merck: Patient & Caregiver U.S. Product Web Site