Dry Eye Disease (DED)
Conditions
Keywords
Dry Eye Disease, DFL24498, Ocular discomfort, Eye dryness, Topical ophthalmic solution
Brief summary
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.
Interventions
DRUGDFL24498
One drop of reconstituted DFL24498 will be instilled topically in each eyes 4 times a day (QID) for 12 weeks.
OTHERVehicle
One drop of reconstituted Vehicle will be instilled topically in each eyes QID for 12 weeks.
Sponsors
Dompé Farmaceutici S.p.A
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in corneal fluorescein staining (CFS) assessed by National Eye Institute (NEI) scale (0 to 15) in the Study Eye | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in ocular dryness symptom assessed by the global score of the Symptom Assessment in Dry Eye (SANDE) questionnaire | 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. |
| Change from baseline in tear production assessed by Schirmer I test without anesthesia in the Study Eye | 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). |
| Change from baseline; in conjunctival fluorescein staining assessed by NEI scale (0 to 18) in the Study Eye. | 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. |
| Number of participants reporting treatment-emergent adverse events | 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. |
Countries
United States
Contacts
CONTACTDompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI)
Outcome results
None listed