Dry EyePhase 2NCT04535947
Study to Evaluate the Efficacy of SDP-4 in Subjects With Dry Eye Disease (DED) (SDP-4-CS202)
A Phase 2 study testing SDP-4 Ophthalmic Solution (1.0%) in people with Dry Eye, run by Silk Technologies, Ltd. at 5 sites in United States.
Trial summary
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. 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 (1.0%)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- 5 sitesUnited States
- Study dates
- 14 Aug 2020to 10 Feb 2021
- 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, as supported by a subject-reported history of daily symptoms of dryeye for ≥ 6 months prior to Visit 1/Screening requiring the use of artificial tears.
- Total score ≥ 40 and ≤ 70 on the SANDE questionnaire at Visits 1 and 2.
- Tear break-up time (TBUT) of ≤ 6 seconds in both eyes at Visits 1 and 2.
- Anesthetized Schirmer's test tear volume ≥ 3 mm and <10 mm in both eyes (only at Visit 1).
- Best-corrected visual acuity (BCVA) of +0.7 logMAR or better in each eye as assessed by logMAR chart at Visits 1 and 2.
Who cannot join
- Ocular surface corneal disease other than DED.
- Diagnosis of Sjögren's disease.
- Lid margin disorder other than meibomian gland dysfunction (MGD)
- Presence of any ocular condition (e.g., pterygium) that in the Investigator's opinion could affect study parameters.
- Any previous reconstructive or cosmetic eyelid surgery
- Any previous invasive glaucoma and/or corneal surgery
Show all 12Show fewer
- Corneal refractive surgery in the 12 months prior to Visit 1/Screening.
- Cataract extraction within 90 days prior to Visit 1/Screening.
- Cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal within 30 days prior to Visit 1/Screening or planned during the study.
- Contact lens wear.
- 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
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Orange County Ophthalmology Medical Group
Garden Grove, California, 92843
Total Eye Care
Memphis, Tennessee, 38119
LoBue Laser and Eye Medical Center
Murrieta, California, 92562
Eye Research Foundation
Newport Beach, California, 92663
Ophthalmology Associates
St Louis, Missouri, 63131
About this study
Official title: A Phase 2, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel Group, Study of SDP-4 Ophthalmic Solution in Subjects With Dry Eye Disease (DED)
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VehicleDrug
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.
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 8 weeks (56 days). Both eyes will be treated.
| Study group | Role | What they receive |
|---|---|---|
| Vehicle | Placebo comparator | Vehicle Receives: Drug: Vehicle |
| SDP-4 Ophthalmic Solution (1.0%) | Experimental | Active Receives: Drug: SDP-4 Ophthalmic Solution (1.0%) |
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 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.
Measured: 56 days
Secondary outcomes (11)
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.
Measured: 56 days
Tear Breakup Time
Mean and mean change from baseline at each visit
Measured: 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.
Measured: 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
Measured: 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
Measured: 56 days
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start14 Aug 2020
- Primary completion10 Feb 2021
- Study completion10 Feb 2021
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 either 1% SDP-4 ophthalmic solution or vehicle in 1:1 ratio in parallel groups.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Silk Technologies, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04535947
- Sponsor's protocol ID
- SDP-4-CS202
- Status last verified
- May 2021
- First submitted
- 27 Aug 2020
- Last updated
- 1 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 1 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, Study of SDP-4 Ophthalmic Solution in Subjects With Dry Eye Disease (DED)
- ClinicalTrials.gov ID
- NCT04535947
- Acronym / sponsor ID
- SDP-4-CS202
- Conditions
- Dry Eye
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Silk Technologies, Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- 10 Feb 2021 (actual)
- Study completion
- 10 Feb 2021 (actual)
- First posted
- 2 Sep 2020 (actual)
- Results
- Posted 1 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-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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized to either 1% SDP-4 ophthalmic solution or vehicle in 1:1 ratio in parallel groups.
| Arm | Type | Receives |
|---|---|---|
| Vehicle | Placebo comparator | Drug: VehicleVehicle |
| SDP-4 Ophthalmic Solution (1.0%) | Experimental | Drug: SDP-4 Ophthalmic Solution (1.0%)Active |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have DED in both eyes, as supported by a subject-reported history of daily symptoms of dryeye for ≥ 6 months prior to Visit 1/Screening requiring the use of artificial tears.
- Total score ≥ 40 and ≤ 70 on the SANDE questionnaire at Visits 1 and 2.
- Tear break-up time (TBUT) of ≤ 6 seconds in both eyes at Visits 1 and 2.
- Anesthetized Schirmer's test tear volume ≥ 3 mm and <10 mm in both eyes (only at Visit 1).
- Best-corrected visual acuity (BCVA) of +0.7 logMAR or better in each eye as assessed by logMAR chart at Visits 1 and 2.
Key exclusion criteria (12 listed)
- Ocular surface corneal disease other than DED.
- Diagnosis of Sjögren's disease.
- Lid margin disorder other than meibomian gland dysfunction (MGD)
- Presence of any ocular condition (e.g., pterygium) that in the Investigator's opinion could affect study parameters.
- Any previous reconstructive or cosmetic eyelid surgery
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 |
|---|---|---|
| VehicleInvestigational 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. | Drug | Vehicle |
| 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 8 weeks (56 days). Both eyes will be treated. | Drug | SDP-4 Ophthalmic Solution (1.0%) |
Primary outcome
Symptom Assessment in Dry Eye (SANDE) Questionnaire
Time frame: 56 days
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.
11 secondary outcomes
Corneal Fluorescein Staining
Time frame: 56 days
Tear Breakup Time
Time frame: 56 days
Conjunctival Hyperemia
Time frame: 56 days
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Burning / Stinging)
Time frame: 56 days
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Discomfort)
Time frame: 56 days
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Dryness)
Time frame: 56 days
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Pain)
Time frame: 56 days
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Fluctuating Vision)
Time frame: 56 days
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Foreign Body Sensation)
Time frame: 56 days
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Itching)
Time frame: 56 days
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Photophobia)
Time frame: 56 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 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 (1.0%) in people with Dry Eye, run by Silk Technologies, Ltd. at 5 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 5 inclusion and 12 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 1 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 5 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 1 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: 56 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 1 Sep 2022.