A Phase 4 interventional study of Fluorometholone Acetate Ophthalmic Suspension 0.1% and Loteprednol Etabonate Ophthalmic Gel 0.38% in Ocular Inflammation, Keratoconjunctivitis and Dry Eye Disease (DED), sponsored by Harrow Inc. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Harrow Inc · Phase 4, Interventional, and Treatment
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.
Background. The use of anti-inflammatory medications is standard practice for managing inflammatory events associated with allergic conjunctivitis, dry eye disease, or post-operative ocular surface inflammation. FLAREX (fluorometholone acetate 0.1%) and Lotemax SM (loteprednol etabonate 0.38%) are both topical corticosteroid ophthalmic products approved for treatment of steroid-responsive ocular surface inflammation.
Objectives. The principal objective was to evaluate the initial comfort and impact on vision of FLAREX versus Lotemax SM. Secondary objectives were palpebral conjunctival injection and corneal staining.
Methods. This was a randomized, single-site, double-masked, controlled study. Each eligible subject received one drop of FLAREX in one eye and one drop of Lotemax SM in the fellow eye, with eye assignment randomized. Study medications were over-labeled "Drop A" and "Drop B" using surgical tape so that the subject and investigator were masked to the medication in each eye; the study coordinator was unmasked and administered the drops out of the subject's view. Subjective and objective measures were captured at three time points: within 30 seconds of instillation, at 5 minutes after instillation, and at 10 minutes after instillation. Adverse events were monitored through 7 days following instillation.
Statistical analysis. A target enrollment of approximately 30 subjects (up to 40) was set; no formal sample size calculation was performed, as the study used approved products in their approved indications with subjective endpoints. The intent-to-treat (ITT) population included all enrolled subjects. The modified ITT (mITT) population included all subjects who completed screening, were eligible, were not treatment failures, and completed all three time-point assessments. The per-protocol (PP) population included mITT subjects compliant with dosing and time-point visits with no significant protocol violations. The primary analysis was performed on the mITT population. Safety analyses were performed on all subjects who received at least one dose. Continuous and ordinal variables were analyzed using parametric methods (t-test, ANOVA, ANCOVA), with descriptive statistics summarizing outcomes at each assessment time point.
27 studies on the registry are indexed under Keratoconjunctivitis; 3 are open to participants now.
This study's enrollment of 40 is below the median of 45 across 19 interventional studies indexed under Keratoconjunctivitis.
Browse Keratoconjunctivitis studies →Harrow Inc is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Drug: Fluorometholone Acetate Ophthalmic Suspension 0.1%
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.
Drug: Loteprednol Etabonate Ophthalmic Gel 0.38%
One drop, single instillation, in randomized eye
Also known as: Flarex
One drop, single instillation, in randomized eye
Also known as: Lotemax SM
Number of Participants by Subject-rated Ocular Comfort
Subject-rated ocular comfort was assessed on a 6-point ordered categorical scale. Response options, from least to most comfortable: 1 = strongly uncomfortable, 2 = very uncomfortable, 3 = slightly uncomfortable, 4 = neither comfortable nor uncomfortable, 5 = slightly comfortable, 6 = extremely comfortable Time frame: 30 seconds, 5 minutes, and 10 minutes after instillation
Time frame: 30 seconds, 5 minutes, and 10 minutes after instillation
Number of Participants by Subject-rated Impact on Vision
5-point ordered categorical scale with response options: "very blurred," "significantly blurred," "slightly blurred," "no impact," and "neither."
Time frame: 30 seconds, 5 minutes, and 10 minutes after instillation
Number of Eyes by Palpebral conjunctival injection (investigator-graded)
Investigator grading scale 1-5 (1 = severe)
Time frame: 30 seconds, 5 minutes, and 10 minutes after instillation
Number of Eyes with Corneal Staining Following Instillation
Fluorescein staining assessment after final evaluation
Time frame: After 10-minute evaluation
Adverse event monitoring (safety follow-up)
Per protocol, adverse events were documented by the investigator and monitored through 7 days following instillation. Only serious adverse events were formally collected and analyzed; non-serious events were documented in clinical progress notes per the IRB-approved protocol.
Time frame: Through 7 days after instillation
Plan to share: Undecided — small tolerability study, summary results can be shared on clinicaltrials.gov
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Harrow Inc