Dry EyePhase 2SDP-4-CS201NCT03889886
Study to Evaluate the Safety and Efficacy of SDP-4 in Subjects With Dry Eye Disease (DED)
A Phase 2 study testing SDP-4 Ophthalmic Solution (0.1%), SDP-4 Ophthalmic Solution (1.0%) and SDP-4 Ophthalmic Solution (3.0%) in people with Dry Eye, run by Silk Technologies, Ltd. at 26 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- SDP-4 Ophthalmic Solution (0.1%), SDP-4 Ophthalmic Solution (1.0%) and SDP-4 Ophthalmic Solution (3.0%)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 305 participants
- Where
- 26 sitesUnited States
- Study dates
- 16 Apr 2019to 11 Oct 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Drs. Quinn, Foster & Associates
Athens, Ohio, 45701
Texan Eye / Keystone Research, Ltd.
Austin, Texas, 78731
Canyon City Eyecare
Azusa, California, 91702
Hernando Eye Institute
Brooksville, Florida, 34615
Abrams Eye Center
Cleveland, Ohio, 44115
Danbury Eye Physicians and Surgeons, PC
Danbury, Connecticut, 06810
Eye Associates of Fort Myers
Fort Myers, Florida, 33901
Orange County Ophthalmology Medical Group
Garden Grove, California, 92843
Wake Forest Health Network Ophthalmology- Oak Hollow
High Point, North Carolina, 27262
Shettle Eye Research
Largo, Florida, 33773
West Coast Eye Institute
Lecanto, Florida, 34461
Total Eye Care
Memphis, Tennessee, 38119
Eye Specialty Group
Memphis, Tennessee, 38120
North Valley Eye Medical Group
Mission Hills, California, 91345
Clayton Eye Clinical Research, LLC
Morrow, Georgia, 30260
LoBue Laser and Eye Medical Center
Murrieta, California, 92562
Nashville Vision Associates
Nashville, Tennessee, 37205
Eye Research Foundation
Newport Beach, California, 92663
North Bay Eye Associates
Petaluma, California, 94954
Kannarr Eye Care
Pittsburg, Kansas, 66762
Coastal Research Associates
Roswell, Georgia, 30076
Grutzmacher & Lewis, A Medical Corporation DBA Sacramento Eye Consultants
Sacramento, California, 95815
Medical Center Ophth Assoc / Keystone Research
San Antonio, Texas, 78240
Heart of America Eye Care, P.A.
Shawnee Mission, Kansas, 66204
Ophthalmology Associates
St Louis, Missouri, 63131
Comprehensive Eye Care Ltd
Washington, Missouri, 63090
About this study
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)
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDP-4 Ophthalmic Solution (0.1%)Drug
Also called SDP-4 (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.
SDP-4 Ophthalmic Solution (1.0%)Drug
Also called SDP-4 (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.
SDP-4 Ophthalmic Solution (3.0%)Drug
Also called SDP-4 (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.
VehicleDrug
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 group | Role | What they receive |
|---|---|---|
| Vehicle | Placebo comparator | Vehicle Receives: Drug: Vehicle |
| SDP-4 Ophthalmic Solution (0.1%) | Experimental | Low concentration of SDP-4 Receives: Drug: SDP-4 Ophthalmic Solution (0.1%) |
| SDP-4 Ophthalmic Solution (1.0%) | Experimental | Mid concentration of SDP-4 Receives: Drug: SDP-4 Ophthalmic Solution (1.0%) |
| SDP-4 Ophthalmic Solution (3.0%) | Experimental | High concentration of SDP-4 Receives: Drug: SDP-4 Ophthalmic Solution (3.0%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 84 days
Secondary outcomes (4)
Tear Breakup Time
Mean change from baseline at each visit
Measured: 84 days
Anesthetized Schirmer's Test
Mean change from baseline at Visit7/Day 84
Measured: 84 days
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.
Measured: 84 days
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.
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start16 Apr 2019
- Primary completion7 Oct 2019
- Study completion11 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Silk Technologies, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jamie Christensen, Study director, Silk Technologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889886
- Sponsor's protocol ID
- SDP-4-CS201
- Acronym
- SDP-4-CS201
- Status last verified
- Aug 2020
- First submitted
- 22 Mar 2019
- Last updated
- 2 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03889886
- Acronym / sponsor ID
- SDP-4-CS201 / SDP-4-CS201
- Conditions
- Dry Eye
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Silk Technologies, Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 7 Oct 2019 (actual)
- Study completion
- 11 Oct 2019 (actual)
- First posted
- 26 Mar 2019 (actual)
- Results
- Posted 2 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Vehicle | Placebo comparator | Drug: VehicleVehicle |
| SDP-4 Ophthalmic Solution (0.1%) | Experimental | Drug: SDP-4 Ophthalmic Solution (0.1%)Low concentration of SDP-4 |
| SDP-4 Ophthalmic Solution (1.0%) | Experimental | Drug: SDP-4 Ophthalmic Solution (1.0%)Mid concentration of SDP-4 |
| SDP-4 Ophthalmic Solution (3.0%) | Experimental | Drug: SDP-4 Ophthalmic Solution (3.0%)High concentration of SDP-4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SDP-4 Ophthalmic Solution (0.1%)Also: SDP-4 (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. | Drug | SDP-4 Ophthalmic Solution (0.1%) |
| SDP-4 Ophthalmic Solution (1.0%)Also: SDP-4 (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. | Drug | SDP-4 Ophthalmic Solution (1.0%) |
| SDP-4 Ophthalmic Solution (3.0%)Also: SDP-4 (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. | Drug | SDP-4 Ophthalmic Solution (3.0%) |
| VehicleInvestigational 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. | Drug | Vehicle |
Primary outcome
Symptom Assessment in Dry Eye (SANDE) Questionnaire
Time frame: 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.
4 secondary outcomes
Tear Breakup Time
Time frame: 84 days
Anesthetized Schirmer's Test
Time frame: 84 days
Conjunctival Hyperemia
Time frame: 84 days
Corneal Fluoroscein Staining
Time frame: 84 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Dry Eye
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie Christensen study director
Silk Technologies
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SDP-4 Ophthalmic Solution (0.1%), SDP-4 Ophthalmic Solution (1.0%) and SDP-4 Ophthalmic Solution (3.0%) in people with Dry Eye, run by Silk Technologies, Ltd. at 26 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Assessment in Dry Eye (SANDE) Questionnaire (time frame: 84 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2022.