Tolerability Comparison of Flarex to Lotemax SM

Tolerability Comparison of Fluorometholone Acetate Ophthalmic Suspension 0.1% (Flarex) to Loteprednol Etabonate Ophthalmic Gel 0.38% (Lotemax SM)

This study compared the ocular tolerability of fluorometholone acetate ophthalmic suspension 0.1% (FLAREX) to loteprednol etabonate ophthalmic gel 0.38% (Lotemax SM) in adult subjects. Each subject received one drop of each product, one in each eye, in a randomized, double-masked design. Comfort, impact on vision, and palpebral conjunctival injection were evaluated at 30 seconds, 5 minutes, and 10 minutes after instillation.

Background. The use of anti-inflammatory medications is standard practice for managing inflammatory events associated with allergic conjunctivitis, dry eye disease, or post-operative ocular surface inflammation. FLAREX (fluorometholone acetate 0.1%) and Lotemax SM (loteprednol etabonate 0.38%) are both topical corticosteroid ophthalmic products approved for treatment of steroid-responsive ocular surface inflammation.

Objectives. The principal objective was to evaluate the initial comfort and impact on vision of FLAREX versus Lotemax SM. Secondary objectives were palpebral conjunctival injection and corneal staining.

Methods. This was a randomized, single-site, double-masked, controlled study. Each eligible subject received one drop of FLAREX in one eye and one drop of Lotemax SM in the fellow eye, with eye assignment randomized. Study medications were over-labeled "Drop A" and "Drop B" using surgical tape so that the subject and investigator were masked to the medication in each eye; the study coordinator was unmasked and administered the drops out of the subject's view. Subjective and objective measures were captured at three time points: within 30 seconds of instillation, at 5 minutes after instillation, and at 10 minutes after instillation. Adverse events were monitored through 7 days following instillation.

Statistical analysis. A target enrollment of approximately 30 subjects (up to 40) was set; no formal sample size calculation was performed, as the study used approved products in their approved indications with subjective endpoints. The intent-to-treat (ITT) population included all enrolled subjects. The modified ITT (mITT) population included all subjects who completed screening, were eligible, were not treatment failures, and completed all three time-point assessments. The per-protocol (PP) population included mITT subjects compliant with dosing and time-point visits with no significant protocol violations. The primary analysis was performed on the mITT population. Safety analyses were performed on all subjects who received at least one dose. Continuous and ordinal variables were analyzed using parametric methods (t-test, ANOVA, ANCOVA), with descriptive statistics summarizing outcomes at each assessment time point.

Inclusion Criteria:

• Able and willing to comprehend and follow the requirements of the study
• Able and willing to provide a signed and dated Informed Consent document and HIPAA authorization
• Male or female of any race or ethnicity, aged 18 years or older
• Able to read and understand English
• Mild to moderate symptoms of ocular surface inflammation associated with allergic conjunctivitis, dry eye disease, or following ocular surgery
• History of use of topical ocular medications
• Subjects of reproductive potential who agree to use a medically acceptable form of birth control during the study and for 30 days following the last dose of investigational product

Exclusion Criteria:

• Suspected alcohol or substance abuse (e.g., amphetamines, benzodiazepines, cocaine, marijuana, opiates)
• Known sensitivity, allergies, or contraindications to any investigational product ingredient
• Pregnancy
• Previously screened and determined to be ineligible for the study
• Use of a therapeutic eye treatment (OTC or prescription) within 2 days of the Screening/Baseline visit
• Relative, partner, or staff of any clinical research site personnel
• Active ocular infection of any type at the start of the study (bacterial, viral, or fungal), or positive history of ocular herpetic infection
• Compromised immune system
• Chronic systemic inflammatory disease (e.g., rheumatoid arthritis, Sjögren's syndrome)
• Contact lens use within 24 hours prior to Visit 1 and during study participation
• Use of any new ocular OTC or prescription medications within 24 hours prior to Visit 1 and throughout study participation