Study to Evaluate the Safety and Efficacy of SDP-4 in Subjects With Dry Eye Disease (DED)
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: SDP-4 Ophthalmic Solution (0.1%); SDP-4 Ophthalmic Solution (1.0%); SDP-4 Ophthalmic Solution (3.0%); Vehicle
Intervention description: 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.; 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.; 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.; 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.
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized to 1 of 3 concentrations (0.1%, 1.0% and 3.0%) of SDP-4 Ophthalmic Solution or vehicle in a 1:1:1:1 ratio in parallel groups.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: All investigational product (SDP-4 concentrations and vehicle) will be provided in single-use doses (SUDs) contained in foil pouches.
Enrollment: 305.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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