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SDP-4-CS201: Study to Evaluate the Safety and Efficacy of SDP-4 in Subjects With Dry Eye Disease (DED)

Sponsor
Silk Technologies, Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03889886
Collaborator
(none)
305
Enrollment
26
Locations
4
Arms
5.8
Actual Duration (Months)
11.7
Patients Per Site
2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: SDP-4 Ophthalmic Solution (0.1%)
  • Drug: SDP-4 Ophthalmic Solution (1.0%)
  • Drug: SDP-4 Ophthalmic Solution (3.0%)
  • Drug: Vehicle
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
305 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
All investigational product (SDP-4 concentrations and vehicle) will be provided in single-use doses (SUDs) contained in foil pouches.
Primary Purpose:
Treatment
Official Title:
A Phase 2, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel Group, Dose-Response Study of SDP-4 Ophthalmic Solution in Subjects With Dry Eye Disease (DED)
Actual Study Start Date :
Apr 16, 2019
Actual Primary Completion Date :
Oct 7, 2019
Actual Study Completion Date :
Oct 11, 2019

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Vehicle

Vehicle

Drug: Vehicle
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.
Experimental: SDP-4 Ophthalmic Solution (0.1%)

Low concentration of SDP-4

Drug: SDP-4 Ophthalmic Solution (0.1%)
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.
Other Names:
  • SDP-4 (0.1%)

    		•
    Experimental: SDP-4 Ophthalmic Solution (1.0%)

    Mid concentration of SDP-4

    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 12 weeks (84 days). Both eyes will be treated.
    Other Names:
  • SDP-4 (1.0%)

    		•
    Experimental: SDP-4 Ophthalmic Solution (3.0%)

    High concentration of SDP-4

    Drug: SDP-4 Ophthalmic Solution (3.0%)
    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.
    Other Names:
  • SDP-4 (3.0%)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Symptom Assessment in Dry Eye (SANDE) Questionnaire [84 days]

      Mean change from baseline in total SANDE score at Visit 7/Day 84

    Secondary Outcome Measures

    1. Tear Breakup Time [84 days]

      Mean change from baseline at each visit

    2. Anesthetized Schirmer's Test [84 days]

      Mean change from baseline at each visit

    3. Conjunctival hyperemia and lissamine green staining measured by slit lamp [84 days]

      Mean change from baseline at each visit

    4. Corneal fluoroscein staining [84 days]

      Mean change from baseline at each visit

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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.

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Canyon City Eyecare Azusa California United States 91702
    2 Orange County Ophthalmology Medical Group Garden Grove California United States 92843
    3 North Valley Eye Medical Group Mission Hills California United States 91345
    4 LoBue Laser and Eye Medical Center Murrieta California United States 92562
    5 Eye Research Foundation Newport Beach California United States 92663
    6 North Bay Eye Associates Petaluma California United States 94954
    7 Grutzmacher & Lewis, A Medical Corporation DBA Sacramento Eye Consultants Sacramento California United States 95815
    8 Danbury Eye Physicians and Surgeons, PC Danbury Connecticut United States 06810
    9 Hernando Eye Institute Brooksville Florida United States 34615
    10 Eye Associates of Fort Myers Fort Myers Florida United States 33901
    11 Shettle Eye Research Largo Florida United States 33773
    12 West Coast Eye Institute Lecanto Florida United States 34461
    13 Clayton Eye Clinical Research, LLC Morrow Georgia United States 30260
    14 Coastal Research Associates Roswell Georgia United States 30076
    15 Kannarr Eye Care Pittsburg Kansas United States 66762
    16 Heart of America Eye Care, P.A. Shawnee Mission Kansas United States 66204
    17 Ophthalmology Associates Saint Louis Missouri United States 63131
    18 Comprehensive Eye Care Ltd Washington Missouri United States 63090
    19 Wake Forest Health Network Ophthalmology- Oak Hollow High Point North Carolina United States 27262
    20 Drs. Quinn, Foster & Associates Athens Ohio United States 45701
    21 Abrams Eye Center Cleveland Ohio United States 44115
    22 Total Eye Care Memphis Tennessee United States 38119
    23 Eye Specialty Group Memphis Tennessee United States 38120
    24 Nashville Vision Associates Nashville Tennessee United States 37205
    25 Texan Eye / Keystone Research, Ltd. Austin Texas United States 78731
    26 Medical Center Ophth Assoc / Keystone Research San Antonio Texas United States 78240

    Sponsors and Collaborators

    • Silk Technologies, Ltd.

    Investigators

    • Study Director: Jamie Christensen, Silk Technologies

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Silk Technologies, Ltd.
    ClinicalTrials.gov Identifier:
    NCT03889886
    Other Study ID Numbers:
    • SDP-4-CS201
    First Posted:
    Mar 26, 2019
    Last Update Posted:
    Aug 28, 2020
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dry Eye Syndromes
    Keratoconjunctivitis Sicca
    Eye Diseases
    Pharmaceutical Solutions
    Ophthalmic Solutions

    Study Results

    No Results Posted as of Aug 28, 2020