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Label indication ZYLET ® (loteprednol etabonate and tobramycin ophthalmic suspension), 0.5%/0.3% is a topical anti-infective and corticosteroid combination for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. FDA label
Also known as Zylet
Loteprednol and tobramycin · 1 trial · 3 indications
The change from baseline (CFB) to Day 15 (Visit 4) in the ocular signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. Per protocol population (PP).
| Arm | Type | Description |
|---|---|---|
| Loteprednol and tobramycin | EXPERIMENTAL | Loteprednol etabonate and tobramycin ophthalmic suspension |
| Tobramycin and dexamethasone | ACTIVE_COMPARATOR | Tobramycin and dexamethasone ophthalmic suspension |
| Name | Type | Description |
|---|---|---|
| Loteprednol and tobramycin | DRUG | Loteprednol etabonate and tobramycin ophthalmic suspension administered to study eye 4 times a day (QID) for 14 days. |
| Tobramycin and dexamethasone | DRUG | Tobramycin and dexamethasone ophthalmic suspension administered to study eye 4 times a day (QID) for 14 days. |
Inclusion Criteria: * Subjects must have a clinical diagnosis of BKC in at least one eye * Subjects must be willing to discontinue contact lens use for the duration of the study * Subjects who are able and willing to comply with all treatment and follow- up/study procedures. Exclusion Criteria: *...
Loteprednol and tobramycin is an investigational combination therapy being studied for the treatment of conjunctivitis, specifically blepharokeratoconjunctivitis, which involves inflammation of the eyelid and cornea. It is being developed by Bausch + Lomb Corporation (NYSE: BLCO) as a small molecule treatment in the ophthalmology therapeutic area.
Loteprednol and tobramycin combines a corticosteroid, loteprednol, which reduces inflammation, with tobramycin, an aminoglycoside antibiotic that targets bacterial infections. This dual mechanism addresses both the inflammatory and infectious components of blepharokeratoconjunctivitis, a condition affecting the eyelids and cornea.
Loteprednol and tobramycin is being developed by Bausch + Lomb Corporation, a company traded on the New York Stock Exchange under the ticker symbol BLCO. The company is conducting clinical research on this combination therapy for the treatment of conjunctivitis and related inflammatory eye conditions.
Loteprednol and tobramycin is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the therapy remains under investigation for the treatment of blepharokeratoconjunctivitis.
Loteprednol and tobramycin has one completed Phase 3 clinical trial, identified as NCT01028027. This study, titled "Loteprednol and Tobramycin Versus Tobramycin and Dexamethasone, in the Treatment of Blepharokeratoconjunctivitis," enrolled 357 participants in Singapore and compared the combination against an active control. The trial included adults aged 18 years and older.