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

A Phase 2, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel Group, Study of SDP-4 Ophthalmic Solution in Subjects With Dry Eye Disease (DED)

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Drug: Vehicle; Drug: SDP-4 Ophthalmic Solution (1.0%)

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Garden Grove, California, United States, 92843
      • Orange County Ophthalmology Medical Group
    • Murrieta, California, United States, 92562
      • LoBue Laser and Eye Medical Center
    • Newport Beach, California, United States, 92663
      • Eye Research Foundation
  • Missouri
    • Saint Louis, Missouri, United States, 63131
      • Ophthalmology Associates
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Vehicle	Drug: Vehicle; Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 8 weeks (56 days). Both eyes will be treated.
EXPERIMENTAL: SDP-4 Ophthalmic Solution (1.0%); Active	Drug: SDP-4 Ophthalmic Solution (1.0%); Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 8 weeks (56 days). Both eyes will be treated.; Other Names: SDP-4 (1.0%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom Assessment in Dry Eye (SANDE) Questionnaire	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.	56 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal Fluorescein Staining	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.	56 days
Tear Breakup Time	Mean and mean change from baseline at each visit	56 days
Conjunctival Hyperemia	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.	56 days
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Burning / Stinging)	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	56 days
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Discomfort)	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	56 days
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Dryness)	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	56 days
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Pain)	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	56 days
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Fluctuating Vision)	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	56 days
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Foreign Body Sensation)	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	56 days
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Itching)	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	56 days
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Photophobia)	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	56 days

Collaborators and Investigators

• Sponsor: Silk Technologies, Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 14, 2020
• Primary Completion (ACTUAL): February 10, 2021
• Study Completion (ACTUAL): February 10, 2021

Study Registration Dates

• First Submitted: August 27, 2020
• First Submitted That Met QC Criteria: August 27, 2020
• First Posted (ACTUAL): September 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 1, 2022
• Last Update Submitted That Met QC Criteria: August 11, 2022
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: SDP-4-CS202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No