Purulent Bacterial ConjunctivitisPhase 3NCT01155999

Clinical Efficacy and Safety of T1225 Versus Tobramycin 0.3 % Eye Drops in the Treatment of Purulent Bacterial Conjunctivitis of Children.

A Phase 3 study testing T1225 and Tobramycin in people with Purulent Bacterial Conjunctivitis, 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.

Official record

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Trial summary

Efficacy/Safety of T1225, in comparison to reference product, for the treatment of purulent bacterial conjunctivitis of children. Read more about this study

Who is it for?: Ages 1 day to 18 years
Conditions the study is for: Purulent Bacterial Conjunctivitis
What is being tested?: T1225 and Tobramycin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 286 participants
Where: 1 siteFrance
Study dates: Dec 2008to Feb 2011
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 1 day to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Age ≥ one day of life and ≤ 18 years
Purulent bacterial conjunctivitis

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

France1 site

Study site
Clermont-Ferrand, 63000

Other trials in France

About this study

Efficacy/Safety of T1225, in comparison to reference product, for the treatment of purulent bacterial conjunctivitis of children.

Conditions: Purulent Bacterial Conjunctivitis
Being tested: T1225, Tobramycin

What participants receive

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

T1225Drug
one drop twice daily (morning and evening) in each eye from Day 0 to Day 2
TobramycinDrug
1 to 2 drops every two hours while awake on Days 0-1, up to 8×/day, then 1 to 2 drops 4 times daily on Days 2-6

Study groups in NCT01155999
Study group	Role	What they receive
T1225	Experimental	Not described Receives: Drug: T1225
Tobramycin	Active comparator	Not described Receives: Drug: Tobramycin

What is being measured

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

The Primary Efficacy Variable Was Clinical Cure in the Worse Eye on Day 3
Clinical cure was defined as a score 0 for bulbar conjunctival injection (evaluated using a 4 point ordinal scale) and a score 0 for conjunctival purulent discharge (evaluated using a 4 point ordinal scale).
Measured: Day 3

Timeline

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

Dec 2008Feb 2011

First posted2 Jul 2010 (estimated)
Study startDec 2008
Primary completionFeb 2011
Study completionFeb 2011

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 Purulent Bacterial ConjunctivitisStudies 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: 286 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01155999
Sponsor's protocol ID: LT1225-PIIIB-02/08
Other IDs: 2008-003567-39, 2008
Status last verified: Sep 2011
First submitted: 30 Jun 2010
Last updated: 29 Oct 2014
Results posted: Yes, on ClinicalTrials.gov

Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Efficacy and Safety of T1225 Versus Tobramycin 0.3 % Eye Drops in the Treatment of Purulent Bacterial Conjunctivitis of Children.
ClinicalTrials.gov ID: NCT01155999
Acronym / sponsor ID: LT1225-PIIIB-02/08
Conditions: Purulent Bacterial Conjunctivitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 286 participants (actual)
Lead sponsor: Laboratoires TheaIndustry (pharma, biotech, devices)
Study start: Dec 2008
Primary completion: Feb 2011 (actual)
Study completion: Feb 2011 (actual)
First posted: 2 Jul 2010 (estimated)
Results: Posted 29 Oct 2014

Clinical summary

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

Efficacy/Safety of T1225, in comparison to reference product, for the treatment of purulent bacterial conjunctivitis of children.

Study design

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

Arm	Type	Receives
T1225	Experimental	Drug: T1225
Tobramycin	Active comparator	Drug: Tobramycin

Who may qualify

Ages: 1 day to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (2 listed)

Age ≥ one day of life and ≤ 18 years
Purulent bacterial conjunctivitis

Key exclusion criteria (0 listed)

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
T1225one drop twice daily (morning and evening) in each eye from Day 0 to Day 2	Drug	T1225
Tobramycin1 to 2 drops every two hours while awake on Days 0-1, up to 8×/day, then 1 to 2 drops 4 times daily on Days 2-6	Drug	Tobramycin

Primary outcome

The Primary Efficacy Variable Was Clinical Cure in the Worse Eye on Day 3
Time frame: Day 3
Clinical cure was defined as a score 0 for bulbar conjunctival injection (evaluated using a 4 point ordinal scale) and a score 0 for conjunctival purulent discharge (evaluated using a 4 point ordinal scale).

Results and safety

Results posted to the registry on 29 Oct 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
T1225	146	139
Tobramycin	140	136

Primary outcome: The Primary Efficacy Variable Was Clinical Cure in the Worse Eye on Day 3

Time frame: Day 3. Number. Unit: participants

Measure	T1225 n = 102	Tobramycin n = 101
Value	48	29

Population analysed: The analysis of the primary clinical efficacy variable was primarily performed on the basis of the MFAS. The MFAS consisted of all patients of the FAS with positive Day 0 culture results in an eligible eye.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
T1225	0 of 146 (0%)	0 of 146 (0%)	Not reported
Tobramycin	0 of 140 (0%)	0 of 140 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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 T1225 and Tobramycin in people with Purulent Bacterial Conjunctivitis, 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 2 inclusion and 0 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 29 Oct 2014. 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 29 Oct 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?

The Primary Efficacy Variable Was Clinical Cure in the Worse Eye on Day 3 (time frame: Day 3). 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 NCT01155999.

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 29 Oct 2014.