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.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Ocular Inflammation; Dry Eye Syndromes; Keratoconjunctivitis; Dry Eye Disease (DED); Post-operative Complications; Kerato Conjunctivitis Sicca
• Intervention / Treatment: Drug: Fluorometholone Acetate Ophthalmic Suspension 0.1%; Drug: Loteprednol Etabonate Ophthalmic Gel 0.38%

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70806
      • Williamson Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FLAREX (randomized eye); Each subject received one drop of fluorometholone acetate ophthalmic suspension 0.1% (FLAREX) in one eye on Day 1. The eye receiving FLAREX was assigned by randomization. The fellow eye received Lotemax SM (see Arm 2).	Drug: Fluorometholone Acetate Ophthalmic Suspension 0.1%; One drop, single instillation, in randomized eye; Other Names: Flarex
Active Comparator: Lotemax SM (fellow eye); Each subject received one drop of loteprednol etabonate ophthalmic gel 0.38% (Lotemax SM) in the eye opposite to the FLAREX-randomized eye, on the same day.	Drug: Loteprednol Etabonate Ophthalmic Gel 0.38%; One drop, single instillation, in randomized eye; Other Names: Lotemax SM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject-rated ocular comfort	Likert scale 1-5 (1 = very uncomfortable, 5 = very comfortable) Time frame: 30 seconds, 5 minutes, and 10 minutes after instillation	30 seconds, 5 minutes, and 10 minutes after instillation
Subject-rated impact on vision	Likert scale 1-5 (1 = profound impact on vision, 5 = no impact on vision)	30 seconds, 5 minutes, and 10 minutes after instillation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Palpebral conjunctival injection (investigator-graded)	Investigator grading scale 1-5 (1 = severe)	30 seconds, 5 minutes, and 10 minutes after instillation
Corneal staining	Fluorescein staining assessment after final evaluation	After 10-minute evaluation

Other Outcome Measures

Outcome Measure	Time Frame
Adverse events	Through 7 days after instillation

Collaborators and Investigators

• Sponsor: Harrow Inc
• Collaborators: Eyevance Pharmaceuticals
• Investigators: Principal Investigator: Joshua Davidson, OD, FAAO, Williamson Eye Center

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: May 8, 2026
• First Submitted That Met QC Criteria: May 8, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: fluorometholone acetate; loteprednol etabonate;; FLAREX
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Corneal Diseases; Lacrimal Apparatus Diseases; Conjunctivitis; Conjunctival Diseases; Keratitis; Pathological Conditions, Signs and Symptoms; Dry Eye Syndromes; Postoperative Complications; Keratoconjunctivitis; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienediols; Fluorometholone
• Other Study ID Numbers: IIS-21-FL-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: small tolerability study, summary results can be shared on clinicaltrials.gov

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No