Study to Evaluate the Efficacy of SDP-4 in Subjects With Dry Eye Disease (DED) (SDP-4-CS202)

Phase 2

Completed

Conditions: Dry Eye

Interventions: Drug: Vehicle
Drug: SDP-4 Ophthalmic Solution (1.0%)

Registration Number: NCT04535947

Lead Sponsor: Silk Technologies, Ltd.

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 153

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	Vehicle	Vehicle
SDP-4 Ophthalmic Solution (1.0%)	SDP-4 Ophthalmic Solution (1.0%)	Active

Primary Outcome Measures

Name	Time	Method
Symptom Assessment in Dry Eye (SANDE) Questionnaire	56 days	Mean change from baseline in total SANDE at Visit 5/Day 56 The SANDE questionnaire contained two questions regarding the frequency and severity of DED symptoms, with a total score being the square root of the frequency score times the square root of the severity score (range 0 100). A higher score indicates more severe DED symptoms.

Secondary Outcome Measures

Name	Time	Method
Corneal Fluorescein Staining	56 days	Mean and mean change from baseline at each visit Reported on a scale of 0-15 with values greater than 3 indicating abnormal incidence of corneal surface irregularity.
Tear Breakup Time	56 days	Mean and mean change from baseline at each visit
Conjunctival Hyperemia	56 days	Mean and mean change from baseline at each visit Reported on a scale of 0-15 with values greater than 3 indicating abnormal incidence of conjunctival surface irregularity.
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Burning / Stinging)	56 days	Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Discomfort)	56 days	Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Dryness)	56 days	Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Pain)	56 days	Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Fluctuating Vision)	56 days	Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Foreign Body Sensation)	56 days	Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Itching)	56 days	Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Photophobia)	56 days	Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome

Trial Locations

Locations (5): Orange County Ophthalmology Medical Group
🇺🇸
Garden Grove, California, United States
LoBue Laser and Eye Medical Center
🇺🇸
Murrieta, California, United States
Eye Research Foundation
🇺🇸
Newport Beach, California, United States
Ophthalmology Associates
🇺🇸
Saint Louis, Missouri, United States
Total Eye Care
🇺🇸
Memphis, Tennessee, United States