Dysautonomia International

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

Purpose

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.

Condition

Dry Eye Disease (DED)

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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.

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.

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Experimental DFL24498	Participants will receive DFL24498 opthalmic solution administered topically in both eyes.	Drug: DFL24498 One drop of reconstituted DFL24498 will be instilled topically in each eyes 4 times a day (QID) for 12 weeks.
Placebo Comparator Vehicle	Participants will receive vehicle opthalmic solution administered topically in both eyes.	Other: Vehicle One drop of reconstituted Vehicle will be instilled topically in each eyes QID for 12 weeks.

Recruiting Locations

Arizona Eye Center
Chandler, Arizona 85224

Canyon City Eyecare
Azusa, California 91702

Global Research Management, Inc.
Glendale, California 91204

United Medical Research Institute
Inglewood, California 90301

Eye Research Foundation
Newport Beach, California 92663

NVision Clinical Research, LLC
Torrance, California 90505

Clayton Eye Clinical Research
Morrow, Georgia 30260

Price Vision Group / Cornea Research Foundation of America
Indianapolis, Indiana 46260

Oculus Research, Inc.
Garner, North Carolina 27529

Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania 16066

Total Eye Care, PA - Memphis
Memphis, Tennessee 38119

Lake Travis Eye and Laser Center
Lakeway, Texas 78738

Piedmont Eye Center
Lynchburg, Virginia 24502

More Details

Status: Recruiting
Sponsor: Dompé Farmaceutici S.p.A

Study Contact

Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI)
+39 02 583 831

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.