NCT07503886 · Dompé Farmaceutici S.p.A
An Exploratory Efficacy and Safety Study of DFL24498 Topical Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease
What this study is about
This is a Phase 2, randomly assigned, conducted at multiple hospitals, double masked, vehicle controlled, parallel group study to evaluate the effectiveness and safety of DFL24498 topical ophthalmic solution versus vehicle in participants with dry eye disease. Approximately 417 participants aged 18 years or older who meet all eligibility criteria will be enrolled at study sites in the US.
View original scientific description
This is a Phase 2, randomized, multicenter, double masked, vehicle controlled, parallel group study to evaluate the efficacy and safety of DFL24498 topical ophthalmic solution versus vehicle in participants with dry eye disease. Approximately 417 participants aged 18 years or older who meet all eligibility criteria will be enrolled at study sites in the US. The study duration will be up to 16 weeks and will consist of three periods.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- A diagnosis of DED at least 6 months before enrollment (current use or recommended use of artificial tears for the treatment of dry eye).
- The global score of the SANDE questionnaire ≥ 30
- DED in at least one eye which is characterized by the following clinical features:
- Schirmer I test without anesthesia \< 10 mm/5 minutes, and
- Total CFS grade ≥ 4 assessed by the NEI grading system, and
- Fluorescein tear film break-up time (TFBUT) \< 10 seconds.
- Best corrected visual acuity (BCVA) score on early treatment of diabetic retinopathy study (ETDRS) chart of ≥ 35 letters (corresponding to ≥ 0.1 Snellen decimal units or ≤ 1.0 Logarithm of the Minimum Angle of Resolution (Chart) \[LogMAR\]) in each eye at the time of study enrollment.
- Only participants who satisfy all informed consent requirements will be included in the study. Key
Exclusion criteria
- Inability to speak and understand the local language sufficiently to understand the nature of the study, to provide written informed consent, and to allow the completion of all study assessments.
- Evidence of an active ocular infection in either eye.
- Anticipated need for ocular surgery during the study period, or any prior ocular surgery for 6 months prior to screening.
- Intraocular inflammation defined as anterior chamber cell or flare \> 0 by Standardization of Uveitis Nomenclature (SUN) grading in either eye.
- Known or suspected ocular malignancy (ocular surface, intraocular, ocular adnexa) in either eye. Note: Additional protocol defined Inclusion/Exclusion criteria apply.
Where
- Chandler, Arizona
- Azusa, California
- Glendale, California
- Inglewood, California
- Murrieta, California
- Newport Beach, California
- Torrance, California
- Largo, Florida
- Tampa, Florida
- Morrow, Georgia
- Indianapolis, Indiana
- Minnetonka, Minnesota
And 12 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 26, 2026 · Source of record for eligibility and locations