Status:
COMPLETED
Efficacy and Safety of T1225 1.5% Versus Tobramycin 0.3 % in the Treatment of Purulent Bacterial Conjunctivitis
Lead Sponsor:
Laboratoires Thea
Conditions:
Conjunctivitis, Bacterial
Eligibility:
All Genders
1+ years
Phase:
PHASE3
Brief Summary
To demonstrate the efficacy of T1225 1.5% eye drops, in comparison to reference product, for the treatment of purulent bacterial conjunctivitis, and to assess the safety
Detailed Description
The aim of the present study was to compare the efficacy and safety of T1225 1.5% eye drops administered BID for 3 days in comparison to reference antibiotic eye drops, tobramycin, for the treatment o...
Eligibility Criteria
Inclusion
- Male or female \>= 1 day old (newborn, infant, child, adult);
- written informed consent by patient or legally acceptable representative;
- purulent bacterial conjunctivitis (unilateral or bilateral) defined as bulbar conjunctival injection (mild, moderate, or severe) AND conjunctival purulent discharge (mild, moderate or severe).
Exclusion
- Bacterial conjunctivitis diagnosed \>= 7 days ago;
- bacterial infection due to trauma or foreign body;
- dacryocystitis;
- corneal ulceration or keratitis;
- viral ocular infection; closed angle glaucoma;
- acute allergy conjunctivitis;
- clinically significant ocular abnormality;
- organic amblyopia, monophthalmia;
- corrected visual acuity below 20/100;
- contact lens wearer;
- newborn (i.e. 0-2 months old) not born at term (\< 37 weeks of amenorrhea);
- ocular surgery, laser in situ keratomileusis (LASIK), laser epithelial keratomileusis (LASEK), or photo-refractive keratectomy (PRK) in last 12 months;
- ocular laser treatment in last 3 months;
- systemic macrolide antibiotics in last month;
- systemic steroids in last 2 weeks or during the study;
- topical ocular macrolide antibiotics and/or topical ocular steroids and/or non-steroidal anti-inflammatory drugs (NSAIDs) in last week;
- topical (ocular, nasal, bronchial etc.) treatments and/or systemic NSAIDs in last day;
- immunosuppressives and/or any systemic antibiotic on D0.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00357773
Start Date
May 1 2004
End Date
June 1 2005
Last Update
July 27 2006
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