Ocular InflammationPhase 4NCT07588074
Tolerability Comparison of Flarex to Lotemax SM
A Phase 4 study testing Fluorometholone Acetate Ophthalmic Suspension 0.1% and Loteprednol Etabonate Ophthalmic Gel 0.38% in people with Ocular Inflammation and Keratoconjunctivitis, run by Harrow Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Inflammation, Keratoconjunctivitis, Dry Eye Disease (DED)
- What is being tested?
- Fluorometholone Acetate Ophthalmic Suspension 0.1% and Loteprednol Etabonate Ophthalmic Gel 0.38%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to 30 Jun 2021
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tolerability Comparison of Fluorometholone Acetate Ophthalmic Suspension 0.1% (Flarex) to Loteprednol Etabonate Ophthalmic Gel 0.38% (Lotemax SM)
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.
Read the detailed description
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.
- Conditions
- Ocular Inflammation, Keratoconjunctivitis, Dry Eye Disease (DED), Post-operative Complications, Kerato Conjunctivitis Sicca, Dry Eye Syndromes
- Being tested
- Fluorometholone Acetate Ophthalmic Suspension 0.1%, Loteprednol Etabonate Ophthalmic Gel 0.38%
- Keywords
- fluorometholone acetate, loteprednol etabonate;, FLAREX
- Medical subject headings
- Keratoconjunctivitis, Dry Eye Syndromes, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorometholone Acetate Ophthalmic Suspension 0.1%Drug
Also called Flarex
One drop, single instillation, in randomized eye
Loteprednol Etabonate Ophthalmic Gel 0.38%Drug
Also called Lotemax SM
One drop, single instillation, in randomized eye
| Study group | Role | What they receive |
|---|---|---|
| FLAREX (randomized eye) | Experimental | 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). Receives: Drug: Fluorometholone Acetate Ophthalmic Suspension 0.1% |
| Lotemax SM (fellow eye) | Active comparator | 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. Receives: Drug: Loteprednol Etabonate Ophthalmic Gel 0.38% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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."
Measured: 30 seconds, 5 minutes, and 10 minutes after instillation
Secondary outcomes (2)
Number of Eyes by Palpebral conjunctival injection (investigator-graded)
Investigator grading scale 1-5 (1 = severe)
Measured: 30 seconds, 5 minutes, and 10 minutes after instillation
Number of Eyes with Corneal Staining Following Instillation
Fluorescein staining assessment after final evaluation
Measured: After 10-minute evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start1 May 2021
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Contralateral-eye (paired) design: each subject received one drop of FLAREX in one eye and one drop of Lotemax SM in the fellow eye on the same day; eye assignment was randomized. Subject and investigator were masked; an unmasked study coordinator administered both drops."
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harrow Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eyevance Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Joshua Davidson, OD, FAAO, Principal investigator, Williamson Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07588074
- Sponsor's protocol ID
- IIS-21-FL-003
- Status last verified
- Sep 2026
- First submitted
- 8 May 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: small tolerability study, summary results can be shared on clinicaltrials.gov