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| Name | Class |
|---|---|
| ORA, Inc. | INDUSTRY |
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The purpose of this study is to evaluate whether SkQ1 Ophthalmic Solution is safe and effective compared to Vehicle for the treatment of the signs and symptoms of dry eye syndrome.
Multi-center, double-masked, randomized, placebo-controlled study comprising 5 visits over the course of approximately 9 weeks. Qualified subjects are randomized 1:1 to receive either SkQ1 Ophthalmic Solution, or Placebo (vehicle of SkQ1 Ophthalmic Solution).
The Primary Endpoints are:
Change from Baseline (Visit 2) to Visit 5 of Ocular Discomfort;
Change from Baseline (Visit 2) to Visit 5 of conjunctival fluorescein staining (sum of temporal and nasal regions)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Comparator: SkQ1 Vehicle | Placebo Comparator | Vehicle for SkQ1 Ophthalmic Solution |
|
| SkQ1 | Active Comparator | SkQ1 Ophthalmic Solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SkQ1 Vehicle Solution | Drug | SkQ1 Ophthalmic Solution Vehicle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Discomfort Scale | Change of Ocular Discomfort Scale, scale ranged from 0 to 4 with 0 = No Discomfort and 4 = Constant Discomfort. | From baseline to Day 57 |
| Conjunctival Fluorescein Staining | Change of Conjunctival Fluorescein Staining (sum of temporal and nasal regions), scale in each region ranged from 0 to 4 with 0 = No Staining and 4 = Confluent Staining | From baseline to Day 57 |
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Inclusion Criteria:
Exclusion Criteria:
self-representation
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence T Friedhoff, MD, PhD | Mitotech, SA | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Eye Institute and Cosmetic Laser | Sun City West | Arizona | 85375 | United States | ||
| Andover Eye Associates |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Comparator: SkQ1 Vehicle | Vehicle for SkQ1 Ophthalmic Solution |
| FG001 | SkQ1 Ophthalmic Solution | SkQ1 Ophthalmic Solution (1.55µg/mL) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Comparator: SkQ1 Vehicle | Vehicle for SkQ1 Ophthalmic Solution |
| BG001 | SkQ1 Ophthalmic Solution | SkQ1 Ophthalmic Solution (1.55µg/mL) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Ocular Discomfort Scale | Change of Ocular Discomfort Scale, scale ranged from 0 to 4 with 0 = No Discomfort and 4 = Constant Discomfort. | Posted | Mean | Standard Deviation | units on a scale | From baseline to Day 57 |
|
|
From Day -7 through end of study (Day 57)
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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 | Placebo Comparator: SkQ1 Vehicle | Vehicle for SkQ1 Ophthalmic Solution | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Instillation site pain | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Operating Officer | Mitotech S.A. | +352621692785 | info@mitotechpharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 4, 2019 | Dec 20, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D007637 | Keratoconjunctivitis |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
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| ID | Term |
|---|---|
| C000600714 | Visomitin |
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Parallel Assignment Parallel-group study SkQ1 Ophthalmic Solution versus placebo (vehicle) solution
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| SkQ1 Ophthalmic Solution | Drug | SkQ1 Ophthalmic Solution |
|
|
| Andover |
| Massachusetts |
| 01810 |
| United States |
| Eye Clinics of South Texas | San Antonio | Texas | 78209 | United States |
| Piedmont Eye Center | Lynchburg | Virginia | 24502 | United States |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Pregnancy |
|
| Unable to attend visits |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Ocular Discomfort Scale | Mean | Standard Deviation | units on a scale |
|
| Participants |
|
|
| Primary | Conjunctival Fluorescein Staining | Change of Conjunctival Fluorescein Staining (sum of temporal and nasal regions), scale in each region ranged from 0 to 4 with 0 = No Staining and 4 = Confluent Staining | Posted | Mean | Standard Deviation | units on a scale | From baseline to Day 57 |
|
|
|
| 306 |
| 2 |
| 306 |
| 19 |
| 306 |
| EG001 | SkQ1 Ophthalmic Solution | SkQ1 Ophthalmic Solution (1.55µg/mL) | 0 | 304 | 2 | 304 | 20 | 304 |
| Atrioventricular block complete | Cardiac disorders | Systematic Assessment |
|
| Colitis ischaemic | Gastrointestinal disorders | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
|
| Visual acuity reduced | Eye disorders | Systematic Assessment |
|
Authorship and manuscript composition will reflect cooperation among all parties involved in the study. Authorship will be established before writing the manuscript. The study sponsor will have the final decision regarding the manuscript and publication.
| D007634 |
| Keratitis |
| D003316 | Corneal Diseases |