NCT00444184

Brief Summary

This 8-week, crossover study will compare the quality of 24-hour IOP control with TTFC versus travoprost when both medications are dosed in the evening. Such a crossover comparison may determine the real efficacy of the new fixed combination versus travoprost monotherapy. The results should enhance the investigators understanding on the best dosing of TTFC and may influence its clinical use in Europe. Finally, the results would better delineate the future role of TTFC in glaucoma management after PG monotherapy, or instead of unfixed therapy with PG analogs and timolol. This study should assist the general ophthalmologist worldwide to plan optimal stepwise medical therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 7, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

May 12, 2014

Status Verified

May 1, 2014

Enrollment Period

10 months

First QC Date

March 5, 2007

Last Update Submit

May 9, 2014

Conditions

Glaucoma

Keywords

travoprost/timolol fixed combination

Outcome Measures

Primary Outcomes (1)

  • Mean 24-hour IOP

    3 months

Secondary Outcomes (3)

  • Mean reduction from baseline

    3 months

  • Mean fluctuation of 24-hour IOP

    3 months

  • Individual IOP readings measured at 10:00 (± 1 hour) and at +4, +8, +12, +16 and +20 (± 1 hour) hours.

    3 months

Study Arms (2)

Travoprost/Timolol therapy

ACTIVE COMPARATOR

24-hour pressure monitoring after 3 months of chronic dosing with travoprost/timolol drops

Drug: Travoprost/timolol fixed combination, travoprost

Travoprost therapy

ACTIVE COMPARATOR

24-hour pressure monitoring after 3 months of chronic dosing with travoprost drops

Drug: Travoprost/timolol fixed combination, travoprost

Interventions

Travoprost/timolol fixed combination, travoprostDRUG
Travoprost therapyTravoprost/Timolol therapy

Eligibility Criteria

Age29 Years - 81 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consecutive adults with primary open-angle glaucoma (POAG) who exhibit a mean untreated IOP greater than 23 m Hg at baseline (10:00).
  • Patient has POAG and is older than 29 years
  • The IOP without treatment is greater than 23 mm Hg and lower than 38 mm Hg at baseline (2 readings at 10:00)
  • Patient can be safely washed out without risk for significant deterioration
  • Distance best corrected Snellen visual acuity better than 1/10
  • Patient can understand the instructions and comply to medications
  • Open normal appearing angles

You may not qualify if:

  • Contraindications to prostaglandins or β-blockers
  • History of lack of response (\<10% reduction) to any medication
  • Female of childbearing potential or lactating mother
  • History of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses
  • Sign of ocular infection, except blepharitis, corneal abnormality that may affect IOP measurements etc

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glaucoma Unit, 1st University Department of Ophthalmology

Thessaloniki, 546 36, Greece

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Travoprost

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

CloprostenolProstaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Anastasios GP Konstas, MD, PhD

    Associate Professor and Head of the Glaucoma Unit, 1st University Department of Ophthalmology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Ophthalmology

Study Record Dates

First Submitted

March 5, 2007

First Posted

March 7, 2007

Study Start

March 1, 2007

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

May 12, 2014

Record last verified: 2014-05

Locations

GR(1)