Tolerability Comparison of Flarex to Lotemax SM

NCT07588074 | Completed Phase 4 FDA Drug

• 1 other identifier: IIS-21-FL-003
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ocular Inflammation; Keratoconjunctivitis; Dry Eye Disease (DED); Kerato Conjunctivitis Sicca; Dry Eye Syndromes; Postoperative Complications

Keywords

fluorometholone acetate; loteprednol etabonate;; FLAREX

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Palpebral conjunctival injection (investigator-graded)

  30 seconds, 5 minutes, and 10 minutes after instillation

• Corneal staining

  After 10-minute evaluation

Other Outcomes (1)

• Adverse events

  Through 7 days after instillation

Study Arms (2)

FLAREX (randomized eye)

EXPERIMENTAL

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%

Lotemax SM (fellow eye)

ACTIVE COMPARATOR

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%

Interventions

Fluorometholone Acetate Ophthalmic Suspension 0.1% DRUG

One drop, single instillation, in randomized eye

Also known as: Flarex

FLAREX (randomized eye)

Loteprednol Etabonate Ophthalmic Gel 0.38% DRUG

One drop, single instillation, in randomized eye

Also known as: Lotemax SM

Lotemax SM (fellow eye)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Harrow Inc: lead
• Eyevance Pharmaceuticals: collaborator

Study Sites (1)

Williamson Eye Center

Baton Rouge, Louisiana, 70806, United States

Location

MeSH Terms

Conditions

Keratoconjunctivitis; Dry Eye Syndromes; Postoperative Complications

Interventions

Fluorometholone

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Keratitis; Corneal Diseases; Lacrimal Apparatus Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Joshua Davidson, OD, FAAO

  Williamson Eye Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Subject and investigator were masked. The unmasked study coordinator administered both drops using over-labeled bottles (Drop A / Drop B) outside the subject's view
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Contralateral-eye (paired) design: each subject received one drop of FLAREX in one eye and one drop of Lotemax SM in the fellow eye on the same day; eye assignment was randomized. Subject and investigator were masked; an unmasked study coordinator administered both drops."

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 14, 2026
• Study Start: May 1, 2021
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: May 14, 2026

Record last verified: 2026-05

Locations

US (1)