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

Study Overview
=================
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.

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)

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Drug: Vehicle
* Drug: SDP-4 Ophthalmic Solution (1.0%)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be randomized to either 1% SDP-4 ophthalmic solution or vehicle in 1:1 ratio in parallel groups.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Vehicle<br>Vehicle | Drug: Vehicle<br>* 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.<br>|
| Experimental: SDP-4 Ophthalmic Solution (1.0%)<br>Active | Drug: SDP-4 Ophthalmic Solution (1.0%)<br>* 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.<br>* Other names: SDP-4 (1.0%);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Tear Breakup Time | Mean and mean change from baseline at each visit | 56 days | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |