CompletedPhase 4

Tolerability Comparison of Flarex to Lotemax SM

United States40 participantsStarted 2021-05-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial compared Flarex and Lotemax SM for conditions like dry eye disease and post-operative inflammation — since it's already completed, has the data been published, and would the results change which eye drop you'd recommend for my situation?
2Since this was a Phase 4 trial, meaning both drops were already approved before this study started, does that give you more confidence about their safety profiles compared to earlier-phase treatments I might come across?
3The trial measured patient-rated comfort and impact on vision specifically — based on what was found, is there a meaningful difference in how these two drops feel or affect vision day-to-day that I should factor into my treatment decision?
4My condition involves dry eye or ocular inflammation — given the completed results of this trial, do you think one of these two steroid eye drops is a better fit for my specific diagnosis compared to the other?
5Are there standard treatment options I should consider before or alongside what this trial was studying, and does the completed data from this comparison change how you'd sequence those options for me?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Subject-rated ocular comfort

Timeframe: 30 seconds, 5 minutes, and 10 minutes after instillation

Subject-rated impact on vision

Timeframe: 30 seconds, 5 minutes, and 10 minutes after instillation

Trial details

NCT IDNCT07588074

SponsorHarrow Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-06-30

View on ClinicalTrials.gov More Ocular Inflammation trials