Phase 3
Completed N=357
Loteprednol and Tobramycin Versus Tobramycin and Dexamethasone, in the Treatment of Blepharokeratoconjunctivitis
Conjunctivitis · Keratitis · Blepharitis
Source: ClinicalTrials.gov NCT01028027 ↗
Enrolled (actual)
357
Serious AEs
0.0%
Results posted
Sep 2011
Primary outcomePrimary: Signs and Symptoms Composite Score - Change From Baseline to Day 15 - PP Population — -11.63; -12.41 Scores on a scale
Summary
This study is to evaluate the safety and efficacy of loteprednol etabonate [LE] and tobramycin ophthalmic suspension versus tobramycin and dexamethasone ophthalmic suspension in the treatment of ocular inflammation associated with blepharokeratoconjunctivitis (BKC).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Signs and Symptoms Composite Score - Change From Baseline to Day 15 - PP Population |
-11.63; -12.41 | — |
| SECONDARY Signs and Symptoms Composite Score - Change From Baseline to Day 15 - ITT Population |
-11.64; -11.98 | — |
| SECONDARY Signs and Symptoms Composite Score - Change From Baseline to Day 8 - PP Population |
-9.20; -10.21 | — |
| SECONDARY Signs and Symptoms Composite Score - Change From Baseline to Day 8 - ITT Population |
-8.91; -9.96 | — |
| SECONDARY Signs and Symptoms Composite Score Change From Baseline to Day 3 - PP Population |
-5.66; -5.98 | — |
| SECONDARY Signs and Symptoms Composite Score Change From Baseline to Day 3 - ITT Population |
-5.54; -5.92 | — |
Eligibility Criteria
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
- Subjects participating in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.
- Subjects who have any uncontrolled systemic disease or debilitating disease.
- Subjects who have a known hypersensitivity to the study drugs or their components (including benzalkonium chloride) or contraindications to tobramycin or ocular corticosteroids.
- Subjects who use any topical or systemic ophthalmic medications listed as disallowed in the study protocol, within the specified time frame prior to Visit 1.
- Subjects who have a disease or conditions which the Investigator determines could interfere with the safety and efficacy evaluations of the study drug.
- Subjects having ocular surgery (including laser surgery) in either eye within the past three months.
Data sourced from ClinicalTrials.gov (NCT01028027). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.