Tolerability Comparison of Flarex to Lotemax SM

Part of paid clinical trials in Baton Rouge, Louisiana.

Sponsor
Harrow Inc
Study ID
NCT07588074
Phase
PHASE4
Status
Completed

Conditions

  • Dry Eye Disease (DED)
  • Dry Eye Syndromes
  • Kerato Conjunctivitis Sicca
  • Keratoconjunctivitis
  • Ocular Inflammation
  • Post-operative Complications
  • Postoperative Complications

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fluorometholone Acetate Ophthalmic Suspension 0.1% — DRUG
    One drop, single instillation, in randomized eye
  • Loteprednol Etabonate Ophthalmic Gel 0.38% — DRUG
    One drop, single instillation, in randomized eye

Study Details

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 Dates

Start date
May 1, 2021
Status verified
May 2026
Primary completion
Jun 30, 2021
Completion
Jun 30, 2021

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • 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).
  • 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.

Primary Outcome Measure

Subject-rated ocular comfort [ Time Frame: 30 seconds, 5 minutes, and 10 minutes after instillation ]

Locations (1)

FacilityCityStateZIPSite coordinators
Williamson Eye CenterBaton RougeLouisiana70806-

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By research site
Williamson Eye Center· Baton Rouge, LA

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