An Exploratory Efficacy and Safety Study of DFL24498 Topical Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DFL24498, Vehicle.
- Who it may be relevant to
- Registry conditions: Dry Eye Disease (DED). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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
- Drug DFL24498
One drop of reconstituted DFL24498 will be instilled topically in each eyes 4 times a day (QID) for 12 weeks. - Other Vehicle
One drop of reconstituted Vehicle will be instilled topically in each eyes QID for 12 weeks.
Primary outcome measures
- 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]
Secondary outcome measures (4)
- 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]]
- Change from baseline in tear production assessed by Schirmer I test without anesthesia in the Study Eye [Time frame: Baseline to Week 12]
- Change from baseline; in conjunctival fluorescein staining assessed by NEI scale (0 to 18) in the Study Eye. [Time frame: Baseline to Week 12]
- Number of participants reporting treatment-emergent adverse events [Time frame: Up to Week 14]
Eligibility criteria
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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 24 centers
- Arizona Eye Center — Chandler
- Canyon City Eyecare — Azusa
- Global Research Management, Inc. — Glendale
- United Medical Research Institute — Inglewood
- LoBue Laser and Eye Medical Center — Murrieta
- Eye Research Foundation — Newport Beach
- NVision Clinical Research, LLC — Torrance
- Shettle Eye Research, Inc. — Largo
- … and 16 more centers
Identifiers
NCT: NCT07503886 · ICY-DED-201