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Which eye drop stings less? small study pits flarex against lotemax SM

NCT ID NCT07588074

Symptom relief Sponsor: Harrow Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested how comfortable two prescription steroid eye drops feel right after use. Forty adults with eye inflammation or dry eye received one drop of Flarex in one eye and one drop of Lotemax SM in the other. They rated comfort and vision impact at 30 seconds, 5 minutes, and 10 minutes. The goal was to see which drop is easier to tolerate.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
fluorometholone acetate ophthalmic suspension 0.1% (Flarex) and loteprednol etabonate ophthalmic gel 0.38% (Lotemax SM)
What this could lead to
If one drop is clearly more comfortable, doctors may prefer it for patients who need steroid eye drops.
What could go wrong
This was a very small, single-dose study in 40 people, so results may not apply to long-term use or to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

40 people

The number who actually took part.

Started

May 2021

Finished

Jun 2021

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 of any new ocular OTC or prescription medications within 24 hours prior to Visit 1 and throughout study participation

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Conditions

The condition(s) this trial relates to.

atopic conjunctivitis dry eye syndrome keratoconjunctivitis Postoperative Complications

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dry eye disease (DED) Dry eye syndromes Kerato conjunctivitis sicca Keratoconjunctivitis Ocular inflammation Post operative complications Postoperative complications

Contacts and locations

Locations

  • Williamson Eye Center

    Baton Rouge, Louisiana, 70806, United States

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