Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| ORA, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate whether SkQ1 ophthalmic solutions are safe and effective compared to placebo 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 1:1:1 to receive either High Dose SkQ1 ophthalmic solution, Low Dose SkQ1 ophthalmic solution, or Placebo (vehicle of SkQ1 ophthalmic solution).
The Primary Endpoints are:
Change from Baseline (Visit 2) to Visit 5 in Corneal Fluorescein Staining;
Change from Baseline (Visit 2) to Visit 5 in Grittiness Symptom
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SkQ1 Vehicle | Placebo Comparator | SkQ1 (Vehicle) |
|
| Low Dose - SkQ1 | Active Comparator | Low-dose ophthalmic solution |
|
| High Dose - SkQ1 | Active Comparator | High-dose ophthalmic solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Dose - SkQ1 | Drug | SkQ1 Low dose ophthalmic solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Central Corneal Staining Change From Baseline | Change of Corneal Fluorescein Staining from baseline to Day 57, scale ranges from 0 to 4, where grade 0 = None, 4 = Severe | From baseline to Day 57 |
| Grittiness Change From Baseline | Change of patient-reported grittiness from baseline to Day 57, scale ranges from 0 to 5 for each symptom, where 0 = None and 5 = Worst | From baseline to Day 57 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lawrence T Friedhoff, MD, PhD | Mitotech, SA | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cornea & Cataract Consultants of Arizona | Phoenix | Arizona | 85032 | United States | ||
| Eye Research Foundation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SkQ1 Vehicle | Vehicle for SkQ1 ophthalmic solution |
| FG001 | Low Dose - SkQ1 | SkQ1 Low dose ophthalmic solution |
| FG002 | High Dose - SkQ1 | SkQ1 High Dose ophthalmic solution |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SkQ1 Vehicle | Vehicle for SkQ1 ophthalmic solution |
| BG001 | Low Dose - SkQ1 | SkQ1 Low dose ophthalmic solution |
| 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 | Central Corneal Staining Change From Baseline | Change of Corneal Fluorescein Staining from baseline to Day 57, scale ranges from 0 to 4, where grade 0 = None, 4 = Severe | Posted | Mean | Standard Deviation | score on a scale | From baseline to Day 57 |
|
From Day -7 through end of study (Day 57)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SkQ1 Vehicle | Vehicle for SkQ1 ophthalmic solution | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ovarian cancer | Reproductive system and breast disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Instillation site pain | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Operating Officer | Mitotech S.A. | +352621692785 | info@mitotechpharma.com |
Not provided
| 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 | Sep 13, 2018 | Dec 20, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D007637 | Keratoconjunctivitis |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000600714 | Visomitin |
Not provided
Not provided
Not provided
Parallel-group study of two strengths of ophthalmic solution versus placebo solution
Not provided
Not provided
Not provided
| High dose - SkQ1 | Drug | SkQ1 High Dose ophthalmic solution |
|
|
| SkQ1 (Vehicle) | Drug | Vehicle for SkQ1 ophthalmic solution |
|
| Newport Beach |
| California |
| 92663 |
| United States |
| Eye Care Insititute | Louisville | Kentucky | 40206 | United States |
| Central Maine Eye Care | Lewiston | Maine | 04240 | United States |
| Andover Eye Associates | Andover | Massachusetts | 01810 | United States |
| Vita Eye Clinic | Shelby | North Carolina | 28150 | United States |
| Total Eye Care, PA | Memphis | Tennessee | 38119 | United States |
| BG002 |
| High Dose - SkQ1 |
SkQ1 High Dose ophthalmic solution |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Central CFS | Mean | Standard Deviation | units on a scale |
|
|
|
| Primary | Grittiness Change From Baseline | Change of patient-reported grittiness from baseline to Day 57, scale ranges from 0 to 5 for each symptom, where 0 = None and 5 = Worst | Posted | Mean | Standard Deviation | score on a scale | From baseline to Day 57 |
|
|
|
| 151 |
| 1 |
| 151 |
| 3 |
| 151 |
| EG001 | Low Dose - SkQ1 | SkQ1 Low dose ophthalmic solution | 0 | 149 | 3 | 149 | 4 | 149 |
| EG002 | High Dose - SkQ1 | SkQ1 High Dose ophthalmic solution | 0 | 151 | 2 | 151 | 3 | 151 |
| Peripheral arterial occlusive disorder | Vascular disorders | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | Systematic Assessment |
|
| Procedural pain | Surgical and medical procedures | Systematic Assessment |
|
| Migraine | Nervous system 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 |