GlaucomaPhase 3NCT01156012

Efficacy and Safety Assessment of T2345 in Ocular Hypertensive or Glaucomatous Patients

A Phase 3 study testing T2345 and Prostaglandin in people with Glaucoma, run by Laboratoires Thea at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Glaucoma
What is being tested?: T2345 and Prostaglandin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 404 participants
Where: 1 siteFrance
Study dates: Sep 2009to Dec 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult patients diagnosed with glaucoma

Who cannot join

Under 18.

Trial locations and contacts

1 site in 1 country.

France1 site

Medical Director
Clermont-Ferrand, 63000

Other trials in France

About this study

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

Conditions: Glaucoma
Being tested: T2345, Prostaglandin
Medical subject headings: Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

T2345Drug
One drop of T2345
ProstaglandinDrug
One drop

Study groups in NCT01156012
Study group	Role	What they receive
T2345	Experimental	One drop of T2345 Receives: Drug: T2345
Prostaglandin	Active comparator	One drop Receives: Drug: Prostaglandin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 0 and Day 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2009Dec 2010

First posted2 Jul 2010 (estimated)
Study startSep 2009
Primary completionDec 2010
Study completionDec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for GlaucomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 404 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01156012
Sponsor's protocol ID: LT2345-PIII-12/08
Other IDs: 2009-011157-41, 2009
Status last verified: Dec 2014
First submitted: 30 Jun 2010
Last updated: 22 Jan 2015
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
Glaucoma
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)

All Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety Assessment of T2345 in Ocular Hypertensive or Glaucomatous Patients
ClinicalTrials.gov ID: NCT01156012
Acronym / sponsor ID: LT2345-PIII-12/08
Conditions: Glaucoma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 404 participants (actual)
Lead sponsor: Laboratoires TheaIndustry (pharma, biotech, devices)
Study start: Sep 2009
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 2 Jul 2010 (estimated)
Results: Posted 19 Nov 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
T2345	Experimental	Drug: T2345One drop of T2345
Prostaglandin	Active comparator	Drug: ProstaglandinOne drop

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Adult patients diagnosed with glaucoma

Key exclusion criteria (1 listed)

Under 18.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
T2345One drop of T2345	Drug	T2345
ProstaglandinOne drop	Drug	Prostaglandin

Primary outcome

Change From Baseline in Intraocular Pressure (IOP)
Time frame: Day 0 and Day 84
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.

Results and safety

Results posted to the registry on 19 Nov 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
T2345	213	206
Prostaglandin	189	186

Primary outcome: Change From Baseline in Intraocular Pressure (IOP)

Time frame: Day 0 and Day 84. Mean (Standard Deviation). Unit: mmHg

Measure	T2345 n = 189	Prostaglandin n = 164
Value	-8.6 (2.6)	-9.0 (2.4)

Population analysed: mITT set : All randomised patients, with at least one eligible eye, having received at least one dose of the Investigational Medicinal Product, and for whom any follow-up IOP recording was available for the worse eye.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
T2345	5 of 213 (2.3%)	0 of 213 (0%)	Not reported
Prostaglandin	1 of 189 (0.5%)	0 of 189 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Glaucoma

Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
Glaucoma
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing T2345 and Prostaglandin in people with Glaucoma, run by Laboratoires Thea at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Intraocular Pressure (IOP) (time frame: Day 0 and Day 84). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01156012.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2015.