Study to Evaluate the Safety and Efficacy of SDP-4 in Subjects With Dry Eye Disease (DED)
Public ClinicalTrials.gov record NCT03889886. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03889886
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 305 participants
Conditions and interventions
Conditions
Interventions
- SDP-4 Ophthalmic Solution (0.1%) Drug
- SDP-4 Ophthalmic Solution (1.0%) Drug
- SDP-4 Ophthalmic Solution (3.0%) Drug
- Vehicle Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 16, 2019 (Actual)
- Primary completion
- Oct 7, 2019 (Actual)
- Completion
- Oct 11, 2019 (Actual)
- Last update posted
- Sep 2, 2022
2019
United States locations
- U.S. sites
- 26
- U.S. states
- 10
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Canyon City Eyecare | Azusa | California | 91702 | — |
| Orange County Ophthalmology Medical Group | Garden Grove | California | 92843 | — |
| North Valley Eye Medical Group | Mission Hills | California | 91345 | — |
| LoBue Laser and Eye Medical Center | Murrieta | California | 92562 | — |
| Eye Research Foundation | Newport Beach | California | 92663 | — |
| North Bay Eye Associates | Petaluma | California | 94954 | — |
| Grutzmacher & Lewis, A Medical Corporation DBA Sacramento Eye Consultants | Sacramento | California | 95815 | — |
| Danbury Eye Physicians and Surgeons, PC | Danbury | Connecticut | 06810 | — |
| Hernando Eye Institute | Brooksville | Florida | 34615 | — |
| Eye Associates of Fort Myers | Fort Myers | Florida | 33901 | — |
| Shettle Eye Research | Largo | Florida | 33773 | — |
| West Coast Eye Institute | Lecanto | Florida | 34461 | — |
| Clayton Eye Clinical Research, LLC | Morrow | Georgia | 30260 | — |
| Coastal Research Associates | Roswell | Georgia | 30076 | — |
| Kannarr Eye Care | Pittsburg | Kansas | 66762 | — |
| Heart of America Eye Care, P.A. | Shawnee Mission | Kansas | 66204 | — |
| Ophthalmology Associates | St Louis | Missouri | 63131 | — |
| Comprehensive Eye Care Ltd | Washington | Missouri | 63090 | — |
| Wake Forest Health Network Ophthalmology- Oak Hollow | High Point | North Carolina | 27262 | — |
| Drs. Quinn, Foster & Associates | Athens | Ohio | 45701 | — |
| Abrams Eye Center | Cleveland | Ohio | 44115 | — |
| Total Eye Care | Memphis | Tennessee | 38119 | — |
| Eye Specialty Group | Memphis | Tennessee | 38120 | — |
| Nashville Vision Associates | Nashville | Tennessee | 37205 | — |
| Texan Eye / Keystone Research, Ltd. | Austin | Texas | 78731 | — |
| Medical Center Ophth Assoc / Keystone Research | San Antonio | Texas | 78240 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03889886, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 2, 2022 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03889886 live on ClinicalTrials.gov.