Topical eye drop for dry eye disease in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, multicenter, double-masked, vehicle-controlled Phase 2 study to test the efficacy and safety of DFL24498 topical ophthalmic solution in participants with dry eye disease. Approximately 417 adults will be enrolled across U.S. sites and followed for up to 16 weeks, divided into three study periods. Participants will receive either DFL24498 or vehicle and will be evaluated for ocular symptoms, tear film quality, and visual function. Primary endpoints focus on safety and patient-reported relief of dryness and discomfort, with secondary assessments of clinical signs. The study is conducted under a parallel-group design with masking to minimize bias.

Why it matters

Who can join: the full rules

Key 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:

  1. Schirmer I test without anesthesia \< 10 mm/5 minutes, and
  2. Total CFS grade ≥ 4 assessed by the NEI grading system, and
  3. 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 it's running

• Arizona Eye Center
  Chandler, Arizona, United States Recruiting
• Canyon City Eyecare
  Azusa, California, United States Recruiting
• Global Research Management, Inc.
  Glendale, California, United States Recruiting
• United Medical Research Institute
  Inglewood, California, United States Recruiting
• Eye Research Foundation
  Newport Beach, California, United States Recruiting
• NVision Clinical Research, LLC
  Torrance, California, United States Recruiting

Study contacts

• Study coordinator: Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI)
• Phone: +39 02 583 831

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.