Study to Evaluate the Efficacy of SDP-4 in Subjects With Dry Eye Disease (DED) (SDP-4-CS202)

• Sponsor: Silk Technologies, Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04535947
• Collaborator: (none)
• Enrollment: 153
• Locations: 5
• Arms: 2
• Actual Duration (Months): 5.9
• Patients Per Site: 30.6
• Patients Per Site Per Month: 5.2

Study Details

Study Description

Brief Summary

SDP-4-CS202 is a Phase 2, multicenter, double-masked, randomized, vehicle-controlled, parallel group study designed to evaluate the ocular efficacy of SDP-4 ophthalmic solution in subjects with moderate to severe dry eye disease over an 8-week treatment period. Once concentration (1%) of SDP-4 ophthalmic solution will be given in a parallel group to vehicle via topical ocular instillation BID.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Drug: Vehicle; Drug: SDP-4 Ophthalmic Solution (1.0%)	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 153 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Subjects will be randomized to either 1% SDP-4 ophthalmic solution or vehicle in 1:1 ratio in parallel groups.Subjects will be randomized to either 1% SDP-4 ophthalmic solution or vehicle in 1:1 ratio in parallel groups.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: All investigation product (1% SDP-4 ophthalmic solution 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, Study of SDP-4 Ophthalmic Solution in Subjects With Dry Eye Disease (DED)
• Actual Study Start Date: Aug 14, 2020
• Actual Primary Completion Date: Feb 10, 2021
• Actual Study Completion Date: Feb 10, 2021

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 8 weeks (56 days). Both eyes will be treated.
Experimental: SDP-4 Ophthalmic Solution (1.0%) Active	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 8 weeks (56 days). Both eyes will be treated.; Other Names: SDP-4 (1.0%)

Outcome Measures

Primary Outcome Measures

1. Symptom Assessment in Dry Eye (SANDE) Questionnaire [56 days]

   Mean change from baseline in total SANDE at Visit 5/Day 56

Secondary Outcome Measures

1. Corneal fluorescein staining [56 days]

   Mean and mean change from baseline at each visit

2. Tear Breakup Time [56 days]

   Mean and mean change from baseline at each visit

3. Conjunctival hyperemia [56 days]

   Mean and mean change from baseline at each visit

4. Individual symptom Visual Analog Scale (VAS) scores, separately for each symptom [56 days]

   Mean and mean change from baseline at each visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome

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, as supported by a subject-reported history of daily symptoms of dryeye for ≥ 6 months prior to Visit 1/Screening requiring the use of artificial tears.

• Total score ≥ 40 and ≤ 70 on the SANDE questionnaire at Visits 1 and 2.

• Tear break-up time (TBUT) of ≤ 6 seconds in both eyes at Visits 1 and 2.

• Anesthetized Schirmer's test tear volume ≥ 3 mm and <10 mm in both eyes (only at Visit 1).

• Best-corrected visual acuity (BCVA) of +0.7 logMAR or better in each eye as assessed by logMAR chart at Visits 1 and 2.

Exclusion Criteria:

• Ocular surface corneal disease other than DED.

• Diagnosis of Sjögren's disease.

• Lid margin disorder other than meibomian gland dysfunction (MGD)

• Presence of any ocular condition (e.g., pterygium) that in the Investigator's opinion could affect study parameters.

• Any previous reconstructive or cosmetic eyelid surgery

• 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.

• Cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal within 30 days prior to Visit 1/Screening or planned during the study.

• Contact lens wear.

• 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	Orange County Ophthalmology Medical Group	Garden Grove	California	United States	92843
2	LoBue Laser and Eye Medical Center	Murrieta	California	United States	92562
3	Eye Research Foundation	Newport Beach	California	United States	92663
4	Ophthalmology Associates	Saint Louis	Missouri	United States	63131
5	Total Eye Care	Memphis	Tennessee	United States	38119

Sponsors and Collaborators

• Silk Technologies, Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Silk Technologies, Ltd.
• ClinicalTrials.gov Identifier: NCT04535947
• Other Study ID Numbers: SDP-4-CS202
• First Posted: Sep 2, 2020
• Last Update Posted: May 17, 2021
• Last Verified: May 1, 2021

• 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; Ophthalmic Solutions

Study Results

No Results Posted as of May 17, 2021