Clinical trial NCT04535947: Study to Evaluate the Efficacy of SDP-4 in Subjects With Dry Eye Disease (DED) (SDP-4-CS202)
Official title: A Phase 2, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel Group, Study of SDP-4 Ophthalmic Solution in Subjects With Dry Eye Disease (DED)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye
Lead sponsor: Silk Technologies, Ltd.
Sponsor class: INDUSTRY
First posted: 2020-09-02
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized to either 1% SDP-4 ophthalmic solution or vehicle in 1:1 ratio in parallel groups.
Primary purpose: TREATMENT

Brief summary: SDP-4-CS202 is a Phase 2, multicenter, double-masked, randomized, vehicle-controlled, parallel group study designed to evaluate the ocular efficacy of SDP-4 ophthalmic solution in subjects with moderate to severe dry eye disease over an 8-week treatment period. Once concentration (1%) of SDP-4 ophthalmic solution will be given in a parallel group to vehicle via topical ocular instillation BID.


Eligibility criteria: Inclusion Criteria:

* Have DED in both eyes, as supported by a subject-reported history of daily symptoms of dryeye for ≥ 6 months prior to Visit 1/Screening requiring the use of artificial tears.
* Total score ≥ 40 and ≤ 70 on the SANDE questionnaire at Visits 1 and 2.
* Tear break-up time (TBUT) of ≤ 6 seconds in both eyes at Visits 1 and 2.
* Anesthetized Schirmer's test tear volume ≥ 3 mm and \<10 mm in both eyes (only at Visit 1).
* Best-corrected visual acuity (BCVA) of +0.7 logMAR or better in each eye as assessed by logMAR chart at Visits 1 and 2.

Exclusion Criteria:

* Ocular surface corneal disease other than DED.
* Diagnosis of Sjögren's disease.
* Lid margin disorder other than meibomian gland dysfunction (MGD)
* Presence of any ocular condition (e.g., pterygium) that in the Investigator's opinion could affect study parameters.
* Any previous reconstructive or cosmetic eyelid surgery
* Any previous invasive glaucoma and/or corneal surgery
* Corneal refractive surgery in the 12 months prior to Visit 1/Screening.
* Cataract extraction within 90 days prior to Visit 1/Screening.
* Cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal within 30 days prior to Visit 1/Screening or planned during the study.
* Contact lens wear.
* Use of ophthlamic corticosteroids, NSAIDs, antibiotics, antihistamines, IOP lowering medication, in the 30 days prior to Visit 1/Screening
* Serious systemic disease or uncontrolled medical condition that in the judgment of the Investigator could confound study assessments

Primary outcomes:
measure: Symptom Assessment in Dry Eye (SANDE) Questionnaire
timeFrame: 56 days
Secondary outcomes:
measure: Corneal Fluorescein Staining
timeFrame: 56 days
measure: Tear Breakup Time
timeFrame: 56 days
measure: Conjunctival Hyperemia
timeFrame: 56 days
measure: Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Burning / Stinging)
timeFrame: 56 days
measure: Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Discomfort)
timeFrame: 56 days
measure: Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Dryness)
timeFrame: 56 days
measure: Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Pain)
timeFrame: 56 days
measure: Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Fluctuating Vision)
timeFrame: 56 days
measure: Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Foreign Body Sensation)
timeFrame: 56 days
measure: Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Itching)
timeFrame: 56 days
measure: Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Photophobia)
timeFrame: 56 days
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: Orange County Ophthalmology Medical Group
state: California
city: Murrieta
country: United States
facility: LoBue Laser and Eye Medical Center
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Saint Louis
country: United States
facility: Ophthalmology Associates
state: Missouri
city: Memphis
country: United States
facility: Total Eye Care
state: Tennessee
Study officials:
References: