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

Phase 2

Completed

• Conditions: Dry Eye
• Interventions: Drug: SDP-4 Ophthalmic Solution (1.0%); Drug: Vehicle; Drug: SDP-4 Ophthalmic Solution (3.0%); Drug: SDP-4 Ophthalmic Solution (0.1%)

• Registration Number: NCT03889886
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-22
• Study First Submitted QC: 2019-03-25
• Study First Posted: 2019-03-26
• Study Start: 2019-04-16
• Primary Completion: 2019-10-07
• Study Completion: 2019-10-11
• Status Verified: 2020-08
• Results First Submitted: 2022-05-13
• Results First Submitted QC: 2022-08-11
• Last Update Submitted: 2022-08-11
• Results First Posted: 2022-09-02
• Last Update Posted: 2022-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 305

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SDP-4 Ophthalmic Solution (1.0%)	SDP-4 Ophthalmic Solution (1.0%)	Mid concentration of SDP-4
Vehicle	Vehicle	Vehicle
SDP-4 Ophthalmic Solution (3.0%)	SDP-4 Ophthalmic Solution (3.0%)	High concentration of SDP-4
SDP-4 Ophthalmic Solution (0.1%)	SDP-4 Ophthalmic Solution (0.1%)	Low concentration of SDP-4

Primary Outcome Measures

Name	Time	Method
Symptom Assessment in Dry Eye (SANDE) Questionnaire	84 days	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.

Secondary Outcome Measures

Name	Time	Method
Conjunctival Hyperemia	84 days	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.
Tear Breakup Time	84 days	Mean change from baseline at each visit
Corneal Fluoroscein Staining	84 days	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.
Anesthetized Schirmer's Test	84 days	Mean change from baseline at Visit7/Day 84

Trial Locations

Locations (26)

Canyon City Eyecare; 🇺🇸 Azusa, California, United States

Orange County Ophthalmology Medical Group; 🇺🇸 Garden Grove, California, United States

North Valley Eye Medical Group; 🇺🇸 Mission Hills, California, United States

LoBue Laser and Eye Medical Center; 🇺🇸 Murrieta, California, United States

Eye Research Foundation; 🇺🇸 Newport Beach, California, United States

North Bay Eye Associates; 🇺🇸 Petaluma, California, United States

Grutzmacher & Lewis, A Medical Corporation DBA Sacramento Eye Consultants; 🇺🇸 Sacramento, California, United States

Danbury Eye Physicians and Surgeons, PC; 🇺🇸 Danbury, Connecticut, United States

Hernando Eye Institute; 🇺🇸 Brooksville, Florida, United States

Eye Associates of Fort Myers; 🇺🇸 Fort Myers, Florida, United States

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