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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00546286
First received: October 16, 2007
Last updated: May 2, 2014
Last verified: May 2014

October 16, 2007
May 2, 2014
May 2006
August 2007   (final data collection date for primary outcome measure)
Reduction in IOP 4 mmHg (or >= 20%) over a period of 6 or 12 weeks. [ Time Frame: 6 to 12 weeks ] [ Designated as safety issue: No ]
Reduction in Inter Ocular Pressure 4 mmHg (or >/= 20%) over a period of 6 to 12 weeks [ Time Frame: 6 to 12 weeks ]
Complete list of historical versions of study NCT00546286 on ClinicalTrials.gov Archive Site
Not Provided
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A Study to Evaluate the Effectiveness of Cosopt® as First Line Therapy (MK-0507A-153)
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)

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).

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Glaucoma
  • Ocular Hypertension
  • 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.

    Other Name: Cosopt
  • Drug: 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.

    Other Name: Cosopt
  • Experimental: 1
    dorzolamide HCl/timolol maleate
    Intervention: Drug: dorzolamide hydrochloride (+) timolol maleate
  • Experimental: 2
    dorzolamide hydrochloride/timolol maleate + prostaglandin
    Intervention: Drug: Comparator: dorzolamide HCl/timolol maleate + prostaglandin
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 hypertension: the COSOPT first-line study. J Ocul Pharmacol Ther. 2010 Oct;26(5):503-11. doi: 10.1089/jop.2010.0032.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
170
August 2007
August 2007   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00546286
0507A-153, MK0507A-153, 2007_027
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP