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

A Phase 2, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel Group, Dose-Response Study of SDP-4 Ophthalmic Solution in Subjects With Dry Eye Disease (DED)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03889886

Acronym

SDP-4-CS201

Enrollment

305

Registered

2019-03-26

Start date

2019-04-16

Completion date

2019-10-11

Last updated

2022-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye

Brief 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.

Interventions

DRUGSDP-4 Ophthalmic Solution (0.1%)

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.

DRUGSDP-4 Ophthalmic Solution (1.0%)

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.

DRUGSDP-4 Ophthalmic Solution (3.0%)

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.

DRUGVehicle

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, 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.

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Symptom Assessment in Dry Eye (SANDE) Questionnaire	84 days	Mean change from baseline in total SANDE score at Visit 7/Day 84 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.

Secondary

Measure	Time frame	Description
Tear Breakup Time	84 days	Mean change from baseline at each visit
Anesthetized Schirmer's Test	84 days	Mean change from baseline at Visit7/Day 84
Conjunctival Hyperemia	84 days	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.
Corneal Fluoroscein Staining	84 days	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Vehicle Vehicle Vehicle: 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.	76
SDP-4 Ophthalmic Solution (0.1%) Low concentration of SDP-4 SDP-4 Ophthalmic Solution (0.1%): 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.	77
SDP-4 Ophthalmic Solution (1.0%) Mid concentration of SDP-4 SDP-4 Ophthalmic Solution (1.0%): 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.	76
SDP-4 Ophthalmic Solution (3.0%) High concentration of SDP-4 SDP-4 Ophthalmic Solution (3.0%): 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.	76
Total	305

Withdrawals & dropouts

Period	Reason	FG001	FG002	FG003
Overall Study	Adverse Event	0	0	6
Overall Study	Other	1	0	1
Overall Study	Withdrawal by Subject	0	1	0

Baseline characteristics

Characteristic	Total	Vehicle	SDP-4 Ophthalmic Solution (0.1%)	SDP-4 Ophthalmic Solution (1.0%)	SDP-4 Ophthalmic Solution (3.0%)
Age, Continuous	60.3 years STANDARD_DEVIATION 15.08	59.2 years STANDARD_DEVIATION 15.2	60.5 years STANDARD_DEVIATION 15.86	60.1 years STANDARD_DEVIATION 15.58	61.5 years STANDARD_DEVIATION 13.68
Ethnicity (NIH/OMB) Hispanic or Latino	42 Participants	10 Participants	9 Participants	12 Participants	11 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	263 Participants	66 Participants	68 Participants	64 Participants	65 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	7 Participants	1 Participants	4 Participants	1 Participants	1 Participants
Race (NIH/OMB) Black or African American	39 Participants	10 Participants	7 Participants	8 Participants	14 Participants
Race (NIH/OMB) More than one race	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	257 Participants	64 Participants	66 Participants	66 Participants	61 Participants
Sex: Female, Male Female	245 Participants	56 Participants	64 Participants	61 Participants	64 Participants
Sex: Female, Male Male	60 Participants	20 Participants	13 Participants	15 Participants	12 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 76	0 / 76	0 / 75	0 / 69
other Total, other adverse events	15 / 76	14 / 76	16 / 75	23 / 69
serious Total, serious adverse events	1 / 76	0 / 76	0 / 75	0 / 69

Outcome results

Primary

Symptom Assessment in Dry Eye (SANDE) Questionnaire

Mean change from baseline in total SANDE score at Visit 7/Day 84 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: 84 days

Arm	Measure	Value (MEAN)	Dispersion
Vehicle	Symptom Assessment in Dry Eye (SANDE) Questionnaire	-25.66 units on a scale	Standard Deviation 26.685
SDP-4 Ophthalmic Solution (0.1%)	Symptom Assessment in Dry Eye (SANDE) Questionnaire	-25.14 units on a scale	Standard Deviation 25.076
SDP-4 Ophthalmic Solution (1.0%)	Symptom Assessment in Dry Eye (SANDE) Questionnaire	-29.95 units on a scale	Standard Deviation 24.883
SDP-4 Ophthalmic Solution (3.0%)	Symptom Assessment in Dry Eye (SANDE) Questionnaire	-24.81 units on a scale	Standard Deviation 26.685

Secondary

Anesthetized Schirmer's Test

Mean change from baseline at Visit7/Day 84

Time frame: 84 days

Arm	Measure	Value (MEAN)	Dispersion
Vehicle	Anesthetized Schirmer's Test	2.53 millimeter	Standard Deviation 5.582
SDP-4 Ophthalmic Solution (0.1%)	Anesthetized Schirmer's Test	2.95 millimeter	Standard Deviation 6.19
SDP-4 Ophthalmic Solution (1.0%)	Anesthetized Schirmer's Test	1.89 millimeter	Standard Deviation 4.706
SDP-4 Ophthalmic Solution (3.0%)	Anesthetized Schirmer's Test	3.75 millimeter	Standard Deviation 5.699

Secondary

Conjunctival Hyperemia

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: 84 days

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle	Conjunctival Hyperemia	Day 56	-0.9 units on a scale	Standard Deviation 2.3
Vehicle	Conjunctival Hyperemia	Day 7	-0.6 units on a scale	Standard Deviation 1.87
Vehicle	Conjunctival Hyperemia	Day 28	-0.8 units on a scale	Standard Deviation 2.7
Vehicle	Conjunctival Hyperemia	Day 14	-0.6 units on a scale	Standard Deviation 2.28
Vehicle	Conjunctival Hyperemia	Day 84	-0.6 units on a scale	Standard Deviation 2.35
SDP-4 Ophthalmic Solution (0.1%)	Conjunctival Hyperemia	Day 14	-0.8 units on a scale	Standard Deviation 1.78
SDP-4 Ophthalmic Solution (0.1%)	Conjunctival Hyperemia	Day 28	-0.8 units on a scale	Standard Deviation 1.98
SDP-4 Ophthalmic Solution (0.1%)	Conjunctival Hyperemia	Day 56	-0.6 units on a scale	Standard Deviation 1.99
SDP-4 Ophthalmic Solution (0.1%)	Conjunctival Hyperemia	Day 7	-0.7 units on a scale	Standard Deviation 1.82
SDP-4 Ophthalmic Solution (0.1%)	Conjunctival Hyperemia	Day 84	-0.8 units on a scale	Standard Deviation 2.6
SDP-4 Ophthalmic Solution (1.0%)	Conjunctival Hyperemia	Day 56	-0.7 units on a scale	Standard Deviation 2.48
SDP-4 Ophthalmic Solution (1.0%)	Conjunctival Hyperemia	Day 84	-0.3 units on a scale	Standard Deviation 2.45
SDP-4 Ophthalmic Solution (1.0%)	Conjunctival Hyperemia	Day 7	-0.9 units on a scale	Standard Deviation 1.91
SDP-4 Ophthalmic Solution (1.0%)	Conjunctival Hyperemia	Day 14	-0.6 units on a scale	Standard Deviation 2.28
SDP-4 Ophthalmic Solution (1.0%)	Conjunctival Hyperemia	Day 28	-0.9 units on a scale	Standard Deviation 2.14
SDP-4 Ophthalmic Solution (3.0%)	Conjunctival Hyperemia	Day 84	-0.6 units on a scale	Standard Deviation 2.16
SDP-4 Ophthalmic Solution (3.0%)	Conjunctival Hyperemia	Day 7	-0.6 units on a scale	Standard Deviation 2.19
SDP-4 Ophthalmic Solution (3.0%)	Conjunctival Hyperemia	Day 28	-0.6 units on a scale	Standard Deviation 2.59
SDP-4 Ophthalmic Solution (3.0%)	Conjunctival Hyperemia	Day 56	-0.7 units on a scale	Standard Deviation 2.55
SDP-4 Ophthalmic Solution (3.0%)	Conjunctival Hyperemia	Day 14	-0.6 units on a scale	Standard Deviation 1.97

Secondary

Corneal Fluoroscein Staining

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: 84 days

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle	Corneal Fluoroscein Staining	Day 56	-1.2 units on a scale	Standard Deviation 2.36
Vehicle	Corneal Fluoroscein Staining	Day 14	-0.5 units on a scale	Standard Deviation 2.02
Vehicle	Corneal Fluoroscein Staining	Day 84	-0.8 units on a scale	Standard Deviation 1.96
Vehicle	Corneal Fluoroscein Staining	Day 28	-0.9 units on a scale	Standard Deviation 2.55
Vehicle	Corneal Fluoroscein Staining	Day 7	-0.2 units on a scale	Standard Deviation 2.15
SDP-4 Ophthalmic Solution (0.1%)	Corneal Fluoroscein Staining	Day 28	-1.5 units on a scale	Standard Deviation 2.43
SDP-4 Ophthalmic Solution (0.1%)	Corneal Fluoroscein Staining	Day 56	-1.3 units on a scale	Standard Deviation 2.07
SDP-4 Ophthalmic Solution (0.1%)	Corneal Fluoroscein Staining	Day 84	-1.3 units on a scale	Standard Deviation 2.45
SDP-4 Ophthalmic Solution (0.1%)	Corneal Fluoroscein Staining	Day 14	-1.2 units on a scale	Standard Deviation 2.21
SDP-4 Ophthalmic Solution (0.1%)	Corneal Fluoroscein Staining	Day 7	-1.4 units on a scale	Standard Deviation 2.03
SDP-4 Ophthalmic Solution (1.0%)	Corneal Fluoroscein Staining	Day 28	-1.3 units on a scale	Standard Deviation 1.97
SDP-4 Ophthalmic Solution (1.0%)	Corneal Fluoroscein Staining	Day 7	-0.9 units on a scale	Standard Deviation 2.16
SDP-4 Ophthalmic Solution (1.0%)	Corneal Fluoroscein Staining	Day 14	-1.1 units on a scale	Standard Deviation 1.99
SDP-4 Ophthalmic Solution (1.0%)	Corneal Fluoroscein Staining	Day 56	-0.9 units on a scale	Standard Deviation 2.53
SDP-4 Ophthalmic Solution (1.0%)	Corneal Fluoroscein Staining	Day 84	-1.2 units on a scale	Standard Deviation 2.99
SDP-4 Ophthalmic Solution (3.0%)	Corneal Fluoroscein Staining	Day 56	-1.6 units on a scale	Standard Deviation 1.96
SDP-4 Ophthalmic Solution (3.0%)	Corneal Fluoroscein Staining	Day 14	-1.3 units on a scale	Standard Deviation 2.11
SDP-4 Ophthalmic Solution (3.0%)	Corneal Fluoroscein Staining	Day 7	-1.4 units on a scale	Standard Deviation 2
SDP-4 Ophthalmic Solution (3.0%)	Corneal Fluoroscein Staining	Day 28	-1.2 units on a scale	Standard Deviation 2.15
SDP-4 Ophthalmic Solution (3.0%)	Corneal Fluoroscein Staining	Day 84	-1.4 units on a scale	Standard Deviation 2.29

Secondary

Tear Breakup Time

Mean change from baseline at each visit

Time frame: 84 days

Arm	Measure	Group	Value (MEAN)	Dispersion
Vehicle	Tear Breakup Time	Day 7	0.95 seconds	Standard Deviation 1.816
Vehicle	Tear Breakup Time	Day 84	1.44 seconds	Standard Deviation 3.213
Vehicle	Tear Breakup Time	Day 28	1.00 seconds	Standard Deviation 2.246
Vehicle	Tear Breakup Time	Day 56	1.18 seconds	Standard Deviation 2.728
Vehicle	Tear Breakup Time	Day 14	1.08 seconds	Standard Deviation 3.43
SDP-4 Ophthalmic Solution (0.1%)	Tear Breakup Time	Day 28	1.92 seconds	Standard Deviation 4.135
SDP-4 Ophthalmic Solution (0.1%)	Tear Breakup Time	Day 7	1.29 seconds	Standard Deviation 4.433
SDP-4 Ophthalmic Solution (0.1%)	Tear Breakup Time	Day 14	1.15 seconds	Standard Deviation 1.487
SDP-4 Ophthalmic Solution (0.1%)	Tear Breakup Time	Day 56	1.38 seconds	Standard Deviation 2.02
SDP-4 Ophthalmic Solution (0.1%)	Tear Breakup Time	Day 84	1.44 seconds	Standard Deviation 2.097
SDP-4 Ophthalmic Solution (1.0%)	Tear Breakup Time	Day 14	1.37 seconds	Standard Deviation 2.735
SDP-4 Ophthalmic Solution (1.0%)	Tear Breakup Time	Day 28	2.20 seconds	Standard Deviation 4.498
SDP-4 Ophthalmic Solution (1.0%)	Tear Breakup Time	Day 84	1.49 seconds	Standard Deviation 3.177
SDP-4 Ophthalmic Solution (1.0%)	Tear Breakup Time	Day 56	2.13 seconds	Standard Deviation 4.123
SDP-4 Ophthalmic Solution (1.0%)	Tear Breakup Time	Day 7	1.21 seconds	Standard Deviation 2.993
SDP-4 Ophthalmic Solution (3.0%)	Tear Breakup Time	Day 14	1.09 seconds	Standard Deviation 2.175
SDP-4 Ophthalmic Solution (3.0%)	Tear Breakup Time	Day 56	1.29 seconds	Standard Deviation 1.878
SDP-4 Ophthalmic Solution (3.0%)	Tear Breakup Time	Day 28	1.63 seconds	Standard Deviation 3.75
SDP-4 Ophthalmic Solution (3.0%)	Tear Breakup Time	Day 7	0.80 seconds	Standard Deviation 3.085
SDP-4 Ophthalmic Solution (3.0%)	Tear Breakup Time	Day 84	1.09 seconds	Standard Deviation 1.693

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

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

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Masking description

Intervention model description

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Symptom Assessment in Dry Eye (SANDE) Questionnaire

Anesthetized Schirmer's Test

Conjunctival Hyperemia

Corneal Fluoroscein Staining

Tear Breakup Time