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

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ClinicalTrials.gov Identifier: NCT03889886
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Silk Technologies, Ltd.

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
Dry Eye 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 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.
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 : April 16, 2019
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

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 Name: 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 Name: 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 Name: SDP-4 (3.0%)




Primary Outcome Measures :
  1. Symptom Assessment in Dry Eye (SANDE) Questionnaire [ Time Frame: 84 days ]
    Mean change from baseline in total SANDE score at Visit 7/Day 84


Secondary Outcome Measures :
  1. Tear Breakup Time [ Time Frame: 84 days ]
    Mean change from baseline at each visit

  2. Anesthetized Schirmer's Test [ Time Frame: 84 days ]
    Mean change from baseline at each visit

  3. Conjunctival hyperemia and lissamine green staining measured by slit lamp [ Time Frame: 84 days ]
    Mean change from baseline at each visit

  4. Corneal fluoroscein staining [ Time Frame: 84 days ]
    Mean change from baseline at each visit



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03889886


Contacts
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Contact: Jamie Christensen 763-463-9595 jamiechristensen@silk-tech.com

Locations
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United States, California
Orange County Ophthalmology Medical Group Recruiting
Garden Grove, California, United States, 92843
North Valley Eye Medical Group Recruiting
Mission Hills, California, United States, 91345
LoBue Laser and Eye Medical Center Recruiting
Murrieta, California, United States, 92562
Eye Research Foundation Recruiting
Newport Beach, California, United States, 92663
North Bay Eye Associates Recruiting
Petaluma, California, United States, 94954
United States, Connecticut
Danbury Eye Physicians and Surgeons, PC Not yet recruiting
Danbury, Connecticut, United States, 06810
United States, Florida
Hernando Eye Institute Recruiting
Brooksville, Florida, United States, 34615
Eye Associates of Fort Myers Recruiting
Fort Myers, Florida, United States, 33901
Shettle Eye Research Recruiting
Largo, Florida, United States, 33773
West Coast Eye Institute Not yet recruiting
Lecanto, Florida, United States, 34461
United States, Georgia
Clayton Eye Clinical Research, LLC Recruiting
Morrow, Georgia, United States, 30260
Coastal Research Associates Recruiting
Roswell, Georgia, United States, 30076
United States, Kansas
Kannarr Eye Care Recruiting
Pittsburg, Kansas, United States, 66762
Heart of America Eye Care, P.A. Recruiting
Shawnee Mission, Kansas, United States, 66204
United States, Missouri
Comprehensive Eye Care Ltd Recruiting
Washington, Missouri, United States, 63090
United States, North Carolina
Wake Forest Health Network Ophthalmology- Oak Hollow Recruiting
High Point, North Carolina, United States, 27262
United States, Ohio
Drs. Quinn, Foster & Associates Recruiting
Athens, Ohio, United States, 45701
Abrams Eye Center Recruiting
Cleveland, Ohio, United States, 44115
United States, Tennessee
Total Eye Care Recruiting
Memphis, Tennessee, United States, 38119
Eye Specialty Group Not yet recruiting
Memphis, Tennessee, United States, 38120
Nashville Vision Associates Recruiting
Nashville, Tennessee, United States, 37205
United States, Texas
Texan Eye / Keystone Research, Ltd. Recruiting
Austin, Texas, United States, 78731
Medical Center Ophth Assoc / Keystone Research Recruiting
San Antonio, Texas, United States, 78240
Sponsors and Collaborators
Silk Technologies, Ltd.
Investigators
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Study Director: Jamie Christensen Silk Technologies

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Responsible Party: Silk Technologies, Ltd.
ClinicalTrials.gov Identifier: NCT03889886     History of Changes
Other Study ID Numbers: SDP-4-CS201
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions
Ophthalmic Solutions