NCT00333125

Brief Summary

The purpose of this study is to compare the intraocular pressure (IOP)-lowering efficacy and safety of two combination products in patients with open-angle glaucoma or ocular hypertension.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
319

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2006

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, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 2, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

November 18, 2016

Status Verified

May 1, 2012

Enrollment Period

10 months

First QC Date

May 31, 2006

Last Update Submit

November 17, 2016

Conditions

GlaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (1)

  • Mean Intra-Ocular Pressure (IOP)

    6 weeks

Study Arms (2)

Travoprost/Timolol

EXPERIMENTAL
Drug: Travoprost 40 mcg/ml + Timolol 5 mg/ml eye drops, solution (DuoTrav)Other: Timolol Vehicle

Dorzolamide/Timolol

ACTIVE COMPARATOR
Drug: Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (Cosopt)

Interventions

Travoprost 40 mcg/ml + Timolol 5 mg/ml eye drops, solution (DuoTrav)DRUG

One drop in the study eye(s) once daily, 9 PM, for 6 weeks

Also known as: DuoTrav
Travoprost/Timolol
Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (Cosopt)DRUG

One drop in the study eye(s) twice daily for 6 weeks

Also known as: Cosopt
Dorzolamide/Timolol
Timolol VehicleOTHER

One drop in the study eye(s) once daily for 6 weeks

Travoprost/Timolol

Eligibility Criteria

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

You may qualify if:

  • or older.
  • Diagnosis of glaucoma or ocular hypertension.

You may not qualify if:

  • Under 18.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Saeed M, Kadir S, Kaufman SL, Murray RR, Milligan F, Cotton PB. Bleeding following endoscopic sphincterotomy: angiographic management by transcatheter embolization. Gastrointest Endosc. 1989 Jul-Aug;35(4):300-3. doi: 10.1016/s0016-5107(89)72796-6.

    PMID: 2788589RESULT

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Interventions

TravoprostTimololOphthalmic SolutionsSolutionsDuotravdorzolamidedorzolamide-timolol combination

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

CloprostenolProstaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesThiadiazolesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorpholinesOxazinesPharmaceutical SolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Design

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

Study Record Dates

First Submitted

May 31, 2006

First Posted

June 2, 2006

Study Start

April 1, 2006

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

November 18, 2016

Record last verified: 2012-05