A Phase 3 interventional study of Azithromycin (T1225) in Conjunctivitis, Bacterial, sponsored by Laboratoires Thea. Completed. Open to participants aged 1 Day and older. Per ClinicalTrials.gov, last updated 2006-07-27.
Sponsored by Laboratoires Thea · Phase 3, Interventional, and Treatment
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
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 of purulent bacterial conjunctivitis. The study was conducted as a Phase III, multicentre, international, investigator-masked, randomised, parallel-group, non-inferiority study in newborns, children, and adults.
40 studies on the registry are indexed under Conjunctivitis, Bacterial; 2 are open to participants now.
Browse Conjunctivitis, Bacterial studies →Laboratoires Thea is the lead sponsor of 64 studies on the registry; 6 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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Clinical cure in the worse eye on Test of Cure (TOC) visit at Day 9, defined as a score 0 for bulbar conjunctival injection and a score 0 for conjunctival purulent discharge (each graded on 4-point scales)
Clinical cure at Day 3
Microbiological cure at Day 3 and Day 9
Global efficacy.
Tolerance
No study locations are listed for this record.
The record gives a start of May 2004 and a completion of Jun 2005. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jul 2006. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Azithromycin