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

Dry Eye Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04535947
• Other study ID #: SDP-4-CS202
• Status: Completed
• Phase: Phase 2
• Start date: August 14, 2020
• Est. completion date: February 10, 2021

Study information

• Verified date: May 2021
• Source: Silk Technologies, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: February 10, 2021
• Est. primary completion date: February 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Orange County Ophthalmology Medical Group	Garden Grove	California
United States	Total Eye Care	Memphis	Tennessee
United States	LoBue Laser and Eye Medical Center	Murrieta	California
United States	Eye Research Foundation	Newport Beach	California
United States	Ophthalmology Associates	Saint Louis	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 at Visit 5/Day 56; 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.	56 days
Secondary	Corneal Fluorescein Staining	Mean and 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.	56 days
Secondary	Tear Breakup Time	Mean and mean change from baseline at each visit	56 days
Secondary	Conjunctival Hyperemia	Mean and 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.	56 days
Secondary	Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Burning / Stinging)	Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome	56 days
Secondary	Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Discomfort)	Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome	56 days
Secondary	Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Dryness)	Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome	56 days
Secondary	Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Pain)	Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome	56 days
Secondary	Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Fluctuating Vision)	Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome	56 days
Secondary	Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Foreign Body Sensation)	Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome	56 days
Secondary	Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Itching)	Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome	56 days
Secondary	Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Photophobia)	Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome	56 days