Primary Open Angle GlaucomaPhase 2NCT01494753

Pharmacokinetics, Efficacy and Safety Assessment of T2345 Compared With Active Comparator in Newly Diagnosed Patients With Open-angle Glaucoma or Ocular Hypertension

A Phase 2 study testing T2345 and Prostaglandin in people with Primary Open Angle Glaucoma, run by Laboratoires Thea.

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 pharmacokinetics, efficacy and safety of T2345 versus an active comparator. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Primary Open Angle Glaucoma
What is being tested?: T2345 and Prostaglandin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: No sites listed yet
Study dates: Jun 2008to Dec 2008
Phase: Phase 2
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Untreated bilateral newly diagnosed patients with primary open angle glaucoma

Who cannot join

Any ocular hypertension other than chronic open angle glaucoma

About this study

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

Conditions: Primary Open Angle Glaucoma
Being tested: T2345, Prostaglandin
Medical subject headings: Glaucoma, Open-Angle

What participants receive

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

T2345Drug
One drop at 8.00pm.
ProstaglandinDrug
One drop at 8.00pm.

Study groups in NCT01494753
Study group	Role	What they receive
Prostaglandin	Active comparator	One drop. Receives: Drug: Prostaglandin
T2345	Experimental	One drop Receives: Drug: T2345

What is being measured

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

Mean Intra Ocular Pressure (IOP) at 8.00am
Efficacy criteria at 8.00am on Day 42 and on Day84. Worse Eye= the eligible eye (with at least one out of the 4 individual IOP values on Day 0 >= 22 and <=30mmHg) with the highest individual IOP at 8.00am on Day 0. If both eyes are eligible and have the same individual IOP at 8.00am on Day 0, the right eye is considered.
Measured: Day 42 and Day 84 (8.00am for the IOP)

Timeline

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

Jun 2008Dec 2008

First posted19 Dec 2011 (estimated)
Study startJun 2008
Primary completionDec 2008
Study completionDec 2008

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Primary Open Angle 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Investigator
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01494753
Sponsor's protocol ID: LT2345-PII-10/07(IN)
Status last verified: Feb 2024
First submitted: 8 Dec 2011
Last updated: 7 Feb 2024
Results posted: Yes, on ClinicalTrials.gov

Publications

Aptel F, Choudhry R, Stalmans I. Preservative-free versus preserved latanoprost eye drops in patients with open-angle glaucoma or ocular hypertension. Curr Med Res Opin. 2016 Aug;32(8):1457-63. doi: 10.1080/03007995.2016.1202818. Epub 2016 Jun 25.
PubMed 27310103

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?

Official record

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)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma

All Primary Open Angle Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics, Efficacy and Safety Assessment of T2345 Compared With Active Comparator in Newly Diagnosed Patients With Open-angle Glaucoma or Ocular Hypertension
ClinicalTrials.gov ID: NCT01494753
Acronym / sponsor ID: LT2345-PII-10/07(IN)
Conditions: Primary Open Angle Glaucoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Laboratoires TheaIndustry (pharma, biotech, devices)
Study start: Jun 2008
Primary completion: Dec 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 19 Dec 2011 (estimated)
Results: Posted 6 Jan 2015

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 pharmacokinetics, efficacy and safety of T2345 versus an active comparator.

Study design

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

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

Who may qualify

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

Key inclusion criteria (1 listed)

Untreated bilateral newly diagnosed patients with primary open angle glaucoma

Key exclusion criteria (1 listed)

Any ocular hypertension other than chronic open angle glaucoma

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 at 8.00pm.	Drug	T2345
ProstaglandinOne drop at 8.00pm.	Drug	Prostaglandin

Primary outcome

Mean Intra Ocular Pressure (IOP) at 8.00am
Time frame: Day 42 and Day 84 (8.00am for the IOP)
Efficacy criteria at 8.00am on Day 42 and on Day84. Worse Eye= the eligible eye (with at least one out of the 4 individual IOP values on Day 0 >= 22 and <=30mmHg) with the highest individual IOP at 8.00am on Day 0. If both eyes are eligible and have the same individual IOP at 8.00am on Day 0, the right eye is considered.

Results and safety

Results posted to the registry on 6 Jan 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Prostaglandin/T2345	15	15
T2345/Prostaglandin	15	15

Primary outcome: Mean Intra Ocular Pressure (IOP) at 8.00am

Time frame: Day 42 and Day 84 (8.00am for the IOP). Mean (Standard Deviation). Unit: mmHg

Measure	Prostaglandin/T2345 n = 15	T2345/Prostaglandin n = 15
IOP at 8am for the worse eye (PPset) D42	16.6 (3)	16.3 (2.3)
IOP at 8am for the worse eye (PPset) D84	17 (2.2)	15.7 (2.9)

Population analysed: Per protocol (PP) set: All patients enrolled in the study for whom any follow-up efficacy information was evaluable and who did not show any major protocol deviation that could affect the efficacy assessment.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Prostaglandin	0 of 30 (0%)	0 of 30 (0%)	Not reported
T2345	1 of 30 (3.3%)	0 of 30 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27310103Aptel F, Choudhry R, Stalmans I. Preservative-free versus preserved latanoprost eye drops in patients with open-angle glaucoma or ocular hypertension. Curr Med Res Opin. 2016 Aug;32(8):1457-63. doi: 10.1080/03007995.2016.1202818. Epub 2016 Jun 25.

Related trials for Primary Open Angle Glaucoma

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)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma

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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing T2345 and Prostaglandin in people with Primary Open Angle Glaucoma, run by Laboratoires Thea.

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 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 6 Jan 2015). 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?

Mean Intra Ocular Pressure (IOP) at 8.00am (time frame: Day 42 and Day 84 (8.00am for the IOP)). 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 NCT01494753, which also lists 1 linked publication.

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 7 Feb 2024.