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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vehicle | Placebo Comparator | Vehicle |
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| SDP-4 Ophthalmic Solution (0.1%) | Experimental | Low concentration of SDP-4 |
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| SDP-4 Ophthalmic Solution (1.0%) | Experimental | Mid concentration of SDP-4 |
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| SDP-4 Ophthalmic Solution (3.0%) | Experimental | High concentration of SDP-4 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SDP-4 Ophthalmic Solution (0.1%) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 84 days |
| Measure | Description | Time Frame |
|---|---|---|
| Tear Breakup Time | Mean change from baseline at each visit | 84 days |
| Anesthetized Schirmer's Test | Mean change from baseline at Visit7/Day 84 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jamie Christensen | Silk Technologies | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canyon City Eyecare | Azusa | California | 91702 | United States | ||
| Orange County Ophthalmology Medical Group |
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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 12 weeks (84 days). Both eyes will be treated. |
| FG001 | SDP-4 Ophthalmic Solution (0.1%) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Apr 3, 2019 | May 9, 2022 |
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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.
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All investigational product (SDP-4 concentrations and vehicle) will be provided in single-use doses (SUDs) contained in foil pouches.
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| 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 12 weeks (84 days). Both eyes will be treated. |
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| SDP-4 Ophthalmic Solution (3.0%) | Drug | 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. |
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| Vehicle | Drug | 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. |
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| 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. | 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. | 84 days |
| Garden Grove |
| California |
| 92843 |
| United States |
| North Valley Eye Medical Group | Mission Hills | California | 91345 | United States |
| LoBue Laser and Eye Medical Center | Murrieta | California | 92562 | United States |
| Eye Research Foundation | Newport Beach | California | 92663 | United States |
| North Bay Eye Associates | Petaluma | California | 94954 | United States |
| Grutzmacher & Lewis, A Medical Corporation DBA Sacramento Eye Consultants | Sacramento | California | 95815 | United States |
| Danbury Eye Physicians and Surgeons, PC | Danbury | Connecticut | 06810 | United States |
| Hernando Eye Institute | Brooksville | Florida | 34615 | United States |
| Eye Associates of Fort Myers | Fort Myers | Florida | 33901 | United States |
| Shettle Eye Research | Largo | Florida | 33773 | United States |
| West Coast Eye Institute | Lecanto | Florida | 34461 | United States |
| Clayton Eye Clinical Research, LLC | Morrow | Georgia | 30260 | United States |
| Coastal Research Associates | Roswell | Georgia | 30076 | United States |
| Kannarr Eye Care | Pittsburg | Kansas | 66762 | United States |
| Heart of America Eye Care, P.A. | Shawnee Mission | Kansas | 66204 | United States |
| Ophthalmology Associates | St Louis | Missouri | 63131 | United States |
| Comprehensive Eye Care Ltd | Washington | Missouri | 63090 | United States |
| Wake Forest Health Network Ophthalmology- Oak Hollow | High Point | North Carolina | 27262 | United States |
| Drs. Quinn, Foster & Associates | Athens | Ohio | 45701 | United States |
| Abrams Eye Center | Cleveland | Ohio | 44115 | United States |
| Total Eye Care | Memphis | Tennessee | 38119 | United States |
| Eye Specialty Group | Memphis | Tennessee | 38120 | United States |
| Nashville Vision Associates | Nashville | Tennessee | 37205 | United States |
| Texan Eye / Keystone Research, Ltd. | Austin | Texas | 78731 | United States |
| Medical Center Ophth Assoc / Keystone Research | San Antonio | Texas | 78240 | United States |
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. |
| FG002 | 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. |
| FG003 | 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. |
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| NOT COMPLETED |
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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 12 weeks (84 days). Both eyes will be treated. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 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. | Posted | Mean | Standard Deviation | units on a scale | 84 days |
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| Secondary | Tear Breakup Time | Mean change from baseline at each visit | Posted | Mean | Standard Deviation | seconds | 84 days |
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| Secondary | Anesthetized Schirmer's Test | Mean change from baseline at Visit7/Day 84 | Posted | Mean | Standard Deviation | millimeter | 84 days |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | 84 days |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | 84 days |
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84 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 12 weeks (84 days). Both eyes will be treated. | 0 | 76 | 1 | 76 | 15 | 76 |
| EG001 | 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. | 0 | 76 | 0 | 76 | 14 | 76 |
| EG002 | 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. | 0 | 75 | 0 | 75 | 16 | 75 |
| EG003 | 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. | 0 | 69 | 0 | 69 | 23 | 69 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diverticulitis | Gastrointestinal disorders | Non-systematic Assessment | One subject was hospitalized for diverticulitis and recovered. The event was judged not related to treatment. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye Disorders | Eye disorders | Non-systematic Assessment | Category containing a number of different, minor eye conditions. |
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| General Disorders and administration site conditions | General disorders | Non-systematic Assessment | Installation site pain |
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| Investigations | Investigations | Non-systematic Assessment | Intraocular pressure increased Vital dye staining cornea present |
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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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Lawrence | SilkTech Biopharmaceuticals | 6172720691 | brianlawrence@silk-tech.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 24, 2019 | May 9, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 25, 2019 | May 9, 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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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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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. |
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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. |
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