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

Dry Eye Clinical Trial

— SDP-4-CS201  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03889886
• Other study ID #: SDP-4-CS201
• Status: Completed
• Phase: Phase 2
• Start date: April 16, 2019
• Est. completion date: October 11, 2019

Study information

• Verified date: August 2020
• Source: Silk Technologies, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 305
• Est. completion date: October 11, 2019
• Est. primary completion date: October 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Drs. Quinn, Foster & Associates	Athens	Ohio
United States	Texan Eye / Keystone Research, Ltd.	Austin	Texas
United States	Canyon City Eyecare	Azusa	California
United States	Hernando Eye Institute	Brooksville	Florida
United States	Abrams Eye Center	Cleveland	Ohio
United States	Danbury Eye Physicians and Surgeons, PC	Danbury	Connecticut
United States	Eye Associates of Fort Myers	Fort Myers	Florida
United States	Orange County Ophthalmology Medical Group	Garden Grove	California
United States	Wake Forest Health Network Ophthalmology- Oak Hollow	High Point	North Carolina
United States	Shettle Eye Research	Largo	Florida
United States	West Coast Eye Institute	Lecanto	Florida
United States	Eye Specialty Group	Memphis	Tennessee
United States	Total Eye Care	Memphis	Tennessee
United States	North Valley Eye Medical Group	Mission Hills	California
United States	Clayton Eye Clinical Research, LLC	Morrow	Georgia
United States	LoBue Laser and Eye Medical Center	Murrieta	California
United States	Nashville Vision Associates	Nashville	Tennessee
United States	Eye Research Foundation	Newport Beach	California
United States	North Bay Eye Associates	Petaluma	California
United States	Kannarr Eye Care	Pittsburg	Kansas
United States	Coastal Research Associates	Roswell	Georgia
United States	Grutzmacher & Lewis, A Medical Corporation DBA Sacramento Eye Consultants	Sacramento	California
United States	Ophthalmology Associates	Saint Louis	Missouri
United States	Medical Center Ophth Assoc / Keystone Research	San Antonio	Texas
United States	Heart of America Eye Care, P.A.	Shawnee Mission	Kansas
United States	Comprehensive Eye Care Ltd	Washington	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Silk Technologies, Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Tear Breakup Time	Mean change from baseline at each visit	84 days
Secondary	Anesthetized Schirmer's Test	Mean change from baseline at Visit7/Day 84	84 days
Secondary	Conjunctival Hyperemia	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.	84 days
Secondary	Corneal Fluoroscein Staining	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.	84 days