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Tolerability Comparison of Flarex to Lotemax SM

NCT07588074 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-14

No results posted yet for this study

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)
  • Post-operative Complications
  • Kerato Conjunctivitis Sicca
  • Dry Eye Syndromes
  • Postoperative Complications

Interventions

DRUG

Fluorometholone Acetate Ophthalmic Suspension 0.1%

One drop, single instillation, in randomized eye

DRUG

Loteprednol Etabonate Ophthalmic Gel 0.38%

One drop, single instillation, in randomized eye

Sponsors & Collaborators

  • Eyevance Pharmaceuticals

    collaborator UNKNOWN

  • Harrow Inc

    lead INDUSTRY

Principal Investigators

  • Joshua Davidson, OD, FAAO · Williamson Eye Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2021-06-30
Completion
2021-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07588074 on ClinicalTrials.gov