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Compares treatment options for Dry Eye Disease (DED)
Official title An Exploratory Efficacy and Safety Study of DFL24498 Topical Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease
ClinicalTrials.gov ID: NCT07503886
What this study is testing
What is DFL24498?
DFL24498 is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for dry eye disease (ded).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Inability to speak and understand the local language sufficiently to understand the nature of the study, to provide written informed consent, and to...
- 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...
See the full eligibility 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...
- Only participants who satisfy all informed consent requirements will be included in the study. Key
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chandler, Arizona, United States
- Azusa, California, United States
- Glendale, California, United States
- Inglewood, California, United States
- Murrieta, California, United States
- Newport Beach, California, United States
- Torrance, California, United States
- Largo, Florida, United States
- Tampa, Florida, United States
- Morrow, Georgia, United States
- Indianapolis, Indiana, United States
- Minnetonka, Minnesota, United States
- St Louis, Missouri, United States
- Washington, Missouri, United States
- Asheville, North Carolina, United States
- Garner, North Carolina, United States
- Shelby, North Carolina, United States
- Mason, Ohio, United States
- Cranberry Township, Pennsylvania, United States
- Memphis, Tennessee, United States
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandler, Arizona, United States; Azusa, California, United States; Glendale, California, United States; Inglewood, California, United States; Murrieta, California, United States; Newport Beach, California, United States and 18 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.