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| Name | Class |
|---|---|
| ORA, Inc. | INDUSTRY |
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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.
Single-center, double-masked, randomized, placebo-controlled study comprising 4 visits over the course of approximately 5 weeks. The study included a 1-week placebo (SkQ1 vehicle) run-in period between Visit 1 and Visit 2, and approximately 28 days of twice daily (BID) dosing (Visit 2 - Visit 4). Qualified subjects were randomized 1:1:1 to receive either 1.55 µg/mL SkQ1 ophthalmic solution, 0.155 µg/mL SkQ1 ophthalmic solution, or placebo (vehicle of SkQ1 ophthalmic solution).
The following primary endpoints were tested:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose SkQ1 | Experimental | Drug: Low Dose 0.155µg/mL SkQ1 ophthalmic solution administered twice daily for 28 days |
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| High Dose SkQ1 | Experimental | Drug: High Dose 1.55µg/mL SkQ1 ophthalmic solution administered twice daily for 28 days |
|
| Placebo (vehicle) | Placebo Comparator | Drug: Placebo (vehicle) ophthalmic solution administered twice daily for 28 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Dose 0.155µg/mL SkQ1 ophthalmic solution | Drug | eyedrops |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Inferior Corneal Fluorescein Staining | The dry eye sign primary efficacy variable of corneal fluorescein staining of the inferior region of the eye measured on a 0-4 point scale where 0 = no staining and 4 = most staining between treatment arms at day 29 | Day 29 |
| Worst Symptom Based on Diary Data | Worst dry eye symptom (as determined from subject diary data recorded during the 1-week run-in period) evaluated over the seven days preceding Day 29 during the treatment period. The scale was on a 0-5 range where 0= no symptoms and 5= worst symptoms measured for a number of dry eye symptoms. | Day 29 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gail Torkildsen, MD | Lawrence General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lawrence General Hospital | Andover | Massachusetts | 01841 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26733410 | Derived | Petrov A, Perekhvatova N, Skulachev M, Stein L, Ousler G. SkQ1 Ophthalmic Solution for Dry Eye Treatment: Results of a Phase 2 Safety and Efficacy Clinical Study in the Environment and During Challenge in the Controlled Adverse Environment Model. Adv Ther. 2016 Jan;33(1):96-115. doi: 10.1007/s12325-015-0274-5. Epub 2016 Jan 5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose SkQ1 | Low Dose 0.155 μg/mL SkQ1 ophthalmic solution |
| FG001 | High Dose SkQ1 | High Dose 1.55 μg/mL SkQ1 ophthalmic solution |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| High Dose 1.55µg/mL SkQ1 ophthalmic solution |
| Drug |
eyedrops |
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| Placebo (Vehicle) opthalmic solution | Drug | eyedrops |
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| FG002 | Placebo (Vehicle) | Placebo (vehicle) ophthalmic solution |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose - SkQ1 | Low Dose 0.155 μg/mL SkQ1 ophthalmic solution |
| BG001 | High Dose - SkQ1 | High Dose 1.55 μg/mL SkQ1 ophthalmic solution |
| BG002 | Placebo (Vehicle) | Placebo (vehicle) ophthalmic solution |
| BG003 | 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, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | 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 | Inferior Corneal Fluorescein Staining | The dry eye sign primary efficacy variable of corneal fluorescein staining of the inferior region of the eye measured on a 0-4 point scale where 0 = no staining and 4 = most staining between treatment arms at day 29 | Posted | Mean | Standard Deviation | units on a scale | Day 29 |
|
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| Primary | Worst Symptom Based on Diary Data | Worst dry eye symptom (as determined from subject diary data recorded during the 1-week run-in period) evaluated over the seven days preceding Day 29 during the treatment period. The scale was on a 0-5 range where 0= no symptoms and 5= worst symptoms measured for a number of dry eye symptoms. | Posted | Mean | Standard Deviation | units on a scale | Day 29 |
|
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From dilating drop at Day -7 through end of study (Day 29)
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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 | Low Dose SkQ1 | Low Dose 0.155 µg/mL SkQ1 opthalmic solution | 0 | 30 | 1 | 30 | ||
| EG001 | High Dose SkQ1 | High Dose 1.55 µg/mL SkQ1 opthalmic solution | 0 | 30 | 1 | 30 | ||
| EG002 | Placebo (Vehicle) | Placebo (vehicle) ophthalmic solution | 0 | 31 | 3 | 31 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| discomfort | Eye disorders | MedDRA 16.1 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gosse B. Bruinsma | Ciurem Pharma Inc | 613-866-9609 | gbb@CIUREM.COM |
| ID | Term |
|---|---|
| D007638 | Keratoconjunctivitis Sicca |
| D015352 | Dry Eye Syndromes |
| D007637 | Keratoconjunctivitis |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D007634 | Keratitis |
| D003316 | Corneal Diseases |
| D007766 | Lacrimal Apparatus Diseases |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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