NCT01156012

Brief Summary

The purpose of this study is to assess the efficacy and safety of T2345 versus active comparator.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
404

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_3

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
4 years until next milestone

Results Posted

Study results publicly available

November 19, 2014

Completed
Last Updated

January 22, 2015

Status Verified

December 1, 2014

Enrollment Period

1.2 years

First QC Date

June 30, 2010

Results QC Date

November 12, 2014

Last Update Submit

January 9, 2015

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Intraocular Pressure (IOP)

    The worse eye is defined as: * If both eyes are eligible the eye with highest Intraocular pressure (IOP) at Day 0 (D0). If both eyes have the same IOP at D0 the worse eye is the right eye. * If only one eye is eligible this eye is the worse eye. * If neither eye is eligible the worse eye is defined as the eye with the highest IOP at D0. If both eyes have the same IOP at D0 the worse eye is the right eye.

    Day 0 and Day 84

Study Arms (2)

T2345

EXPERIMENTAL

One drop of T2345

Drug: T2345

Prostaglandin

ACTIVE COMPARATOR

One drop

Drug: Prostaglandin

Interventions

T2345DRUG

One drop of T2345

T2345
ProstaglandinDRUG

One drop

Prostaglandin

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients diagnosed with glaucoma

You may not qualify if:

  • Under 18.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Director

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Prostaglandins

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

EicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Results Point of Contact

Title
Dr Pascale Pouliquen - Medical Director
Organization
Laboratoires Théa
p.pouliquen@laboratoires-thea.fr
33 473 981 436

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

June 30, 2010

First Posted

July 2, 2010

Study Start

September 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

January 22, 2015

Results First Posted

November 19, 2014

Record last verified: 2014-12

Locations

FR(1)