Tolerability Comparison of Flarex to Lotemax SM

Completed · Phase 4

Conditions studied: Ocular Inflammation, Keratoconjunctivitis, Dry Eye Disease (DED), Post-operative Complications, Kerato Conjunctivitis Sicca, Dry Eye Syndromes, Postoperative Complications

In brief

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.

Key facts

Study ID

NCT07588074

Run by

Harrow Inc

People needed

40

Starts

2021-05-01

Expected to finish

2021-06-30

Last updated by the study team

2026-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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