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

NCT04535947 | Completed Phase 2 Results FDA Drug

• 1 other identifier: SDP-4-CS202
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 5

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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Corneal Fluorescein Staining

  56 days

• Tear Breakup Time

  56 days

• Conjunctival Hyperemia

  56 days

• Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Burning / Stinging)

  56 days

• Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Discomfort)

  56 days

Study Arms (2)

Vehicle

PLACEBO COMPARATOR

Vehicle

Drug: Vehicle

SDP-4 Ophthalmic Solution (1.0%)

EXPERIMENTAL

Active

Drug: SDP-4 Ophthalmic Solution (1.0%)

Interventions

Vehicle DRUG

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.

Vehicle

SDP-4 Ophthalmic Solution (1.0%) DRUG

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.

Also known as: SDP-4 (1.0%)

SDP-4 Ophthalmic Solution (1.0%)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Silk Technologies, Ltd.: lead

Study Sites (5)

Orange County Ophthalmology Medical Group

Garden Grove, California, 92843, United States

Location

LoBue Laser and Eye Medical Center

Murrieta, California, 92562, United States

Location

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

Ophthalmology Associates

St Louis, Missouri, 63131, United States

Location

Total Eye Care

Memphis, Tennessee, 38119, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Brian Lawrence
• Organization: SilkTech Biopharmaceuticals

brianlawrence@silk-tech.com

6172720691

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All investigation product (1% SDP-4 ophthalmic solution and vehicle) will be provided in single-use doses (SUDs) contained in foil pouches.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized to either 1% SDP-4 ophthalmic solution or vehicle in 1:1 ratio in parallel groups.

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 2, 2020
• Study Start: August 14, 2020
• Primary Completion: February 10, 2021
• Study Completion: February 10, 2021
• Last Updated: September 1, 2022
• Results First Posted: September 1, 2022

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)