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.
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
Schirmer I test without anesthesia < 10 mm/5 minutes, and
Total CFS grade ≥ 4 assessed by the NEI grading system, and
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.
Parallel
DFL24498
DrugOne drop of reconstituted DFL24498 will be instilled topically in each eyes 4 times a day (QID) for 12 weeks.
Vehicle
Other interventionOne drop of reconstituted Vehicle will be instilled topically in each eyes QID for 12 weeks.
Change from baseline in corneal fluorescein staining (CFS) assessed by National Eye Institute (NEI) scale (0 to 15) in the Study Eye
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.
Change from baseline in ocular dryness symptom assessed by the global score of the Symptom Assessment in Dry Eye (SANDE) questionnaire
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.
Change from baseline in tear production assessed by Schirmer I test without anesthesia in the Study Eye
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).
Change from baseline; in conjunctival fluorescein staining assessed by NEI scale (0 to 18) in the Study Eye.
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.
Number of participants reporting treatment-emergent adverse events
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.
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