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NCT Number: NCT07503886

An Exploratory Efficacy and Safety Study of DFL24498 Topical Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease

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.

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Key information

Conditions

Dry Eye Disease (DED) Conjunctival Diseases Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases Xerophthalmia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Arizona Eye Center, Chandler, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.

Treatment and study plan

DFL24498

Drug

One drop of reconstituted DFL24498 will be instilled topically in each eyes 4 times a day (QID) for 12 weeks.

Vehicle

Other

One drop of reconstituted Vehicle will be instilled topically in each eyes QID for 12 weeks.

Primary outcomes

  1. Change from baseline in corneal fluorescein staining (CFS) assessed by National Eye Institute (NEI) scale (0 to 15) in the Study Eye

    Time frame: Baseline to Week 12

    Fluorescein will be applied to the inferior fornix of the palpebral conjunctiva of each eye. To avoid the phenomenon of quenching, staining will be assessed within 1 to 4 minutes from fluorescein instillation. The CFS is performed at the slit lamp with blue (cobalt) light. The staining is graded using the NEI scale, which scores five corneal zones from 0 to 3 (total corneal score 0-15) with higher scores indicating more extensive staining.

Secondary outcomes

  1. Change from baseline in ocular dryness symptom assessed by the global score of the Symptom Assessment in Dry Eye (SANDE) questionnaire

    Time frame: Baseline to Week 12]

    The SANDE questionnaire includes 2 VAS questions that measure the frequency and severity of DED (each scored 0-100). The global score (0-100) is calculated by multiplying the frequency score by the severity score and obtaining the square root.

  2. Change from baseline in tear production assessed by Schirmer I test without anesthesia in the Study Eye

    Time frame: Baseline to Week 12

    Before the external ocular examination and post BCVA, the Schirmer I test is performed without anesthesia to measure the wetting of the strip over 5 minutes, and the moistened length is recorded in millimeters (mm).

  3. Change from baseline; in conjunctival fluorescein staining assessed by NEI scale (0 to 18) in the Study Eye.

    Time frame: Baseline to Week 12

    Fluorescein will be applied to the inferior fornix of the palpebral conjunctiva of each eye. To avoid the phenomenon of quenching, staining will be assessed within 1 to 4 minutes from fluorescein instillation. Corneal fluorescein staining is performed at the slit lamp with blue (cobalt) light. The staining is graded using the NEI scale, which scores six conjunctival zones from 0 to 3 (total conjunctival score 0-18) with higher scores indicating more extensive staining.

  4. Number of participants reporting treatment-emergent adverse events

    Time frame: Up to Week 14

    An adverse event is any untoward medical occurrence in a clinical study participant, associated with the use of study treatment, whether or not it is considered related to the study treatment. Any adverse events occurring or worsening after the first administration of investigational product will be classified as "treatment-emergent" adverse events.

Study contacts

Contact information is provided by the study sponsor or research team.

Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI)

CONTACT

+39 02 583 831

Sponsors and collaborators

Lead sponsor

Dompé Farmaceutici S.p.A

Industry

Registry information

Official study title

A 12-Week, Phase 2, Multicenter, Randomized, Double-Masked, Vehicle Controlled, Parallel Group Study With 2 Weeks of Follow-Up to Evaluate the Efficacy and Safety of DFL24498 0.08% Topical Ophthalmic Solution Versus Vehicle in Participants With Dry Eye Disease

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 31, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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