NCT01881126

Brief Summary

This efficacy and safety study will evaluate LUMIGAN® RC/ LUMIGAN® .01 (bimatoprost 0.01%) alone compared to TRAVATAN Z® (travoprost 0.004%) and TIMOLOL MALEATE-EX, 0.5%/TIMOLOL GFS 0.5% (timolol 0.5% ophthalmic gel forming solution) in patients who require IOP lowering therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

2 active sites

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

June 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

November 30, 2015

Completed
Last Updated

November 30, 2015

Status Verified

October 1, 2015

Enrollment Period

1.3 years

First QC Date

June 17, 2013

Results QC Date

October 27, 2015

Last Update Submit

October 27, 2015

Conditions

GlaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (1)

  • Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM

    IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) is measured at 8 AM, 12 PM, and 4 PM. IOP is either the average of 2 measurements, or, if a third measurement is required, the average of 3 measurements.

    Week 12 at 8 AM, 12 PM, and 4 PM

Study Arms (2)

bimatoprost 0.01% and hypromellose 0.3%

ACTIVE COMPARATOR

Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.

Drug: bimatoprost 0.01%Drug: hypromellose 0.3%

travatan 0.004% and timolol 0.5%

ACTIVE COMPARATOR

Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.

Drug: travatan 0.004%Drug: timolol 0.5%

Interventions

bimatoprost 0.01%DRUG

Bimatoprost 0.01% administered to both eyes once daily for 12 weeks.

Also known as: Lumigan® RC, Lumigan®
bimatoprost 0.01% and hypromellose 0.3%
travatan 0.004%DRUG

Travatan 0.004% administered to both eyes once daily for 12 weeks.

Also known as: Travatan Z®
travatan 0.004% and timolol 0.5%
timolol 0.5%DRUG

Timolol 0.5% administered to both eyes once daily for 12 weeks.

Also known as: Timolol Maleate-EX, Timolol GFS
travatan 0.004% and timolol 0.5%
hypromellose 0.3%DRUG

Hypromellose 0.3% lubricant eye drops (for masking purposes) administered to both eyes once daily for 12 weeks.

Also known as: GenTeal®
bimatoprost 0.01% and hypromellose 0.3%

Eligibility Criteria

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

You may qualify if:

  • Ocular hypertension or glaucoma that requires treatment with medication
  • Have a best corrected visual acuity (BCVA) of 20/100 or better in both eyes

You may not qualify if:

  • History of LASIK, LASEK, RK, and/or PRK in the study eye(s)
  • History of any intraocular surgery or glaucoma laser surgery in the study eye(s) within 3 months
  • Use of topical, periorbital, intravitreal or systemic steroid within 3 months or expected use during the course of study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Barrie, Ontario, Canada

Location

Unknown Facility

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Interventions

BimatoprostTravoprostTimololLubricant Eye Drops

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

AmidesOrganic ChemicalsCloprostenolProstaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsPropanolaminesAmino AlcoholsAlcoholsPropanolsAminesThiadiazolesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorpholinesOxazinesOphthalmic SolutionsPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesLubricantsSpecialty Uses of Chemicals

Results Point of Contact

Title
Vice President Medical Affairs,
Organization
Allergan, Inc
clinicaltrials@allergan.com
714-246-4500

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2013

First Posted

June 19, 2013

Study Start

June 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

November 30, 2015

Results First Posted

November 30, 2015

Record last verified: 2015-10

Locations

CA(2)