NCT00108017

Brief Summary

This study is comparing 2 medications for glaucoma and how effective they are at controlling glaucoma over the course of an entire day.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2005

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 13, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

May 13, 2015

Status Verified

May 1, 2015

Enrollment Period

1.2 years

First QC Date

April 12, 2005

Last Update Submit

May 12, 2015

Conditions

GlaucomaOcular Hypertension

Keywords

Ocular hypertension (excessive pressure in the eye)

Outcome Measures

Primary Outcomes (1)

  • 24 hour diurnal IOP reduction after 8 weeks of treatment

    After 8 weeks of treatment

Secondary Outcomes (1)

  • IOP reduction a) from baseline at 6 weeks; b) comparison with timolol; c) comparison day versus night

    At 6 weeks

Interventions

MK0507A, dorzolamide hydrochloride (+) timolol maleateDRUG
Comparator: timolol maleateDRUG
Duration of Treatment: Part 1) 6 wk timolol maleate run inDRUG
Part 2) 6 wk washout pd Part 3) two 8 wk active tx pdsDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with glaucoma or ocular hypertension

You may not qualify if:

  • Other eye conditions
  • Poor vision
  • Recent eye surgery
  • Use of contact lenses
  • Nursing or pregnant women
  • Use of some other selected medications
  • Drug or alcohol abuse
  • Asthma
  • Slow heart beat
  • Allergy or previous reaction to study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Feldman RM, Stewart RH, Stewart WC, Jia G, Smugar SS, Galet VA. 24-hour control of intraocular pressure with 2% dorzolamide/0.5% timolol fixed-combination ophthalmic solution in open-angle glaucoma. Curr Med Res Opin. 2008 Aug;24(8):2403-12. doi: 10.1185/03007990802243366. Epub 2008 Jul 14.

    PMID: 18627642BACKGROUND

  • Olander KW, Galet VA, Jia G, Smugar SS, Stewart WC. Relationship between visual field severity and response to fixed combination dorzolamide/timolol or timolol alone. J Ocul Pharmacol Ther. 2009 Aug;25(4):357-64. doi: 10.1089/jop.2008.0104.

    PMID: 19441888BACKGROUND

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Interventions

dorzolamideTimolol

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesThiadiazolesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorpholinesOxazines

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2005

First Posted

April 13, 2005

Study Start

April 1, 2005

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

May 13, 2015

Record last verified: 2015-05