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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
153
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.
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.
Orange County Ophthalmology Medical Group
Garden Grove, California, United States
LoBue Laser and Eye Medical Center
Murrieta, California, United States
Eye Research Foundation
Newport Beach, California, United States
Ophthalmology Associates
St Louis, Missouri, United States
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.
Time frame: 56 days
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.
Time frame: 56 days
Tear Breakup Time
Mean and mean change from baseline at each visit
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 56 days
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Total Eye Care
Memphis, Tennessee, United States
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 56 days