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

NCT ID: NCT01155999

Last Updated: 2014-10-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

286 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2011-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Purulent Bacterial Conjunctivitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

T1225

Group Type EXPERIMENTAL

T1225

Intervention Type DRUG

one drop twice daily (morning and evening) in each eye from Day 0 to Day 2

Tobramycin

Group Type ACTIVE_COMPARATOR

Tobramycin

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

T1225

one drop twice daily (morning and evening) in each eye from Day 0 to Day 2

Intervention Type DRUG

Tobramycin

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

1 Day

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Laboratoires Thea

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clermont-Ferrand, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2008-003567-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LT1225-PIIIB-02/08

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pediatric Zylet Safety and Efficacy Study
NCT00420628 COMPLETED PHASE4
Systemic Pharmacokinetics of BOL-303224-A
NCT00407589 COMPLETED PHASE1
Efficacy of T2259 in DED
NCT03874429 COMPLETED NA