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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vehicle | Placebo Comparator | Vehicle |
|
| SDP-4 Ophthalmic Solution (1.0%) | Experimental | Active |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vehicle | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 56 days |
| Tear Breakup Time |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orange County Ophthalmology Medical Group | Garden Grove | California | 92843 | United States | ||
| LoBue Laser and Eye Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vehicle | Vehicle Vehicle: 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. |
| FG001 | SDP-4 Ophthalmic Solution (1.0%) | Active SDP-4 Ophthalmic Solution (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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vehicle | Vehicle Vehicle: 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. |
| BG001 | SDP-4 Ophthalmic Solution (1.0%) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 56 days |
|
56 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vehicle | Vehicle Vehicle: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Detached Retina | Eye disorders | Non-systematic Assessment | One subject reported recent loss of vision, was diagnosed with a macula off retinal detachment with blurred vision during the course of the study. The event was judged not related to SDP-4 treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye Pain | Eye disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Lawrence | SilkTech Biopharmaceuticals | 6172720691 | brianlawrence@silk-tech.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 12, 2020 | May 13, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 24, 2019 | May 16, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 16, 2020 | May 13, 2022 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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Subjects will be randomized to either 1% SDP-4 ophthalmic solution or vehicle in 1:1 ratio in parallel groups.
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All investigation product (1% SDP-4 ophthalmic solution and vehicle) will be provided in single-use doses (SUDs) contained in foil pouches.
| SDP-4 Ophthalmic Solution (1.0%) | Drug | 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. |
|
|
Mean and mean change from baseline at each visit
| 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 56 days |
| Murrieta |
| California |
| 92562 |
| United States |
| Eye Research Foundation | Newport Beach | California | 92663 | United States |
| Ophthalmology Associates | St Louis | Missouri | 63131 | United States |
| Total Eye Care | Memphis | Tennessee | 38119 | United States |
| Withdrawal by Subject |
|
Active SDP-4 Ophthalmic Solution (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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Iris Color | Count of Participants | Participants |
|
Active
SDP-4 Ophthalmic Solution (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.
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 56 days |
|
|
|
| Secondary | Tear Breakup Time | Mean and mean change from baseline at each visit | Posted | Mean | Standard Deviation | seconds | 56 days |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 56 days |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | units on a scale | 56 days |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | units on a scale | 56 days |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | units on a scale | 56 days |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | units on a scale | 56 days |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | units on a scale | 56 days |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | units on a scale | 56 days |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | units on a scale | 56 days |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | units on a scale | 56 days |
|
|
|
| 0 |
| 76 |
| 0 |
| 76 |
| 8 |
| 76 |
| EG001 | SDP-4 Ophthalmic Solution (1.0%) | Active SDP-4 Ophthalmic Solution (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. | 0 | 77 | 1 | 77 | 8 | 77 |
|
| Installation Site Pain | General disorders | Non-systematic Assessment |
|
| Blepharitis | Eye disorders | Non-systematic Assessment |
|
| Conjunctivitis Allergic | Eye disorders | Non-systematic Assessment |
|
| Cystoid macular oedema | Eye disorders | Non-systematic Assessment |
|
| Eyelid Oedema | Eye disorders | Non-systematic Assessment |
|
| Eyelid Ptosis | Eye disorders | Non-systematic Assessment |
|
| Retinal Detachment | Eye disorders | Non-systematic Assessment |
|
| Vision Blurred | Eye disorders | Non-systematic Assessment |
|
| Visual Acuity Reduced | Eye disorders | Non-systematic Assessment |
|
| Installation Site Discomfort | General disorders | Non-systematic Assessment |
|
All information concerning SDP-4 and the operations of Silk Technologies, such as patent applications, formulas, manufacturing processes, basic scientific data or formulation information not previously published, are considered CONFIDENTIAL and shall remain the sole property of Silk Technologies. The Investigator agrees to use this information only in accomplishing this study and will not use it for other purposes without the written consent of Silk Technologies
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