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

NCT03889886 | Completed Phase 2 Results FDA Drug

• 1 other identifier: SDP-4-CS201
• Study Type: interventional
• Target: 305
• Locations: 1 country
• Sites: 26

Brief Summary

SDP-4-CS201, is a Phase 2, multi-center, double-masked, randomized, vehicle-controlled, dose-response, parallel-group study designed to evaluate the ocular and systemic safety and efficacy of SDP-4 ophthalmic solution in subjects with moderate to severe dry eye disease over a 12-week treatment period. Three concentrations (0.1%, 1.0% and 3.0%) of SDP-4 ophthalmic solution will be given to parallel groups 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 score at Visit 7/Day 84 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.

  84 days

Secondary Outcomes (4)

• Tear Breakup Time

  84 days

• Anesthetized Schirmer's Test

  84 days

• Conjunctival Hyperemia

  84 days

• Corneal Fluoroscein Staining

  84 days

Study Arms (4)

Vehicle

PLACEBO COMPARATOR

Vehicle

Drug: Vehicle

SDP-4 Ophthalmic Solution (0.1%)

EXPERIMENTAL

Low concentration of SDP-4

Drug: SDP-4 Ophthalmic Solution (0.1%)

SDP-4 Ophthalmic Solution (1.0%)

EXPERIMENTAL

Mid concentration of SDP-4

Drug: SDP-4 Ophthalmic Solution (1.0%)

SDP-4 Ophthalmic Solution (3.0%)

EXPERIMENTAL

High concentration of SDP-4

Drug: SDP-4 Ophthalmic Solution (3.0%)

Interventions

SDP-4 Ophthalmic Solution (0.1%) DRUG

Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.

Also known as: SDP-4 (0.1%)

SDP-4 Ophthalmic Solution (0.1%)

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 12 weeks (84 days). Both eyes will be treated.

Also known as: SDP-4 (1.0%)

SDP-4 Ophthalmic Solution (1.0%)

SDP-4 Ophthalmic Solution (3.0%) DRUG

Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.

Also known as: SDP-4 (3.0%)

SDP-4 Ophthalmic Solution (3.0%)

Vehicle DRUG

Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.

Vehicle

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 for ≥ 6 months prior to Visit 1/Screening.
• Total score ≥ 40 on the SANDE questionnaire.
• Tear break-up time (TBUT) of ≤ 6 seconds in both eyes.
• Anesthetized Schirmer's test tear volume ≥ 4 mm and \<10 mm in both eyes.

You may not qualify if:

• Ocular surface corneal disease, other than DED.
• Lid margin disorder other than meibomian gland dysfunction (MGD).
• Any previous reconstructive or cosmetic eyelid surgery that may affect the normal function of the lids
• 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.
• 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 (26)

Canyon City Eyecare

Azusa, California, 91702, United States

Location

Orange County Ophthalmology Medical Group

Garden Grove, California, 92843, United States

Location

North Valley Eye Medical Group

Mission Hills, California, 91345, 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

North Bay Eye Associates

Petaluma, California, 94954, United States

Location

Grutzmacher & Lewis, A Medical Corporation DBA Sacramento Eye Consultants

Sacramento, California, 95815, United States

Location

Danbury Eye Physicians and Surgeons, PC

Danbury, Connecticut, 06810, United States

Location

Hernando Eye Institute

Brooksville, Florida, 34615, United States

Location

Eye Associates of Fort Myers

Fort Myers, Florida, 33901, United States

Location

Shettle Eye Research

Largo, Florida, 33773, United States

Location

West Coast Eye Institute

Lecanto, Florida, 34461, United States

Location

Clayton Eye Clinical Research, LLC

Morrow, Georgia, 30260, United States

Location

Coastal Research Associates

Roswell, Georgia, 30076, United States

Location

Kannarr Eye Care

Pittsburg, Kansas, 66762, United States

Location

Heart of America Eye Care, P.A.

Shawnee Mission, Kansas, 66204, United States

Location

Ophthalmology Associates

St Louis, Missouri, 63131, United States

Location

Comprehensive Eye Care Ltd

Washington, Missouri, 63090, United States

Location

Wake Forest Health Network Ophthalmology- Oak Hollow

High Point, North Carolina, 27262, United States

Location

Drs. Quinn, Foster & Associates

Athens, Ohio, 45701, United States

Location

Abrams Eye Center

Cleveland, Ohio, 44115, United States

Location

Total Eye Care

Memphis, Tennessee, 38119, United States

Location

Eye Specialty Group

Memphis, Tennessee, 38120, United States

Location

Nashville Vision Associates

Nashville, Tennessee, 37205, United States

Location

Texan Eye / Keystone Research, Ltd.

Austin, Texas, 78731, United States

Location

Medical Center Ophth Assoc / Keystone Research

San Antonio, Texas, 78240, 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

Study Officials

• Jamie Christensen

  Silk Technologies

  STUDY DIRECTOR

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 investigational product (SDP-4 concentrations 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 1 of 3 concentrations (0.1%, 1.0% and 3.0%) of SDP-4 Ophthalmic Solution or vehicle in a 1:1:1:1 ratio in parallel groups.

Study Record Dates

• First Submitted: March 22, 2019
• First Posted: March 26, 2019
• Study Start: April 16, 2019
• Primary Completion: October 7, 2019
• Study Completion: October 11, 2019
• Last Updated: September 2, 2022
• Results First Posted: September 2, 2022

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (26)