Trial Outcomes & Findings for Vehicle-Controlled Study of SkQ1 as Treatment for Dry-eye Syndrome (NCT NCT04206020)

NCT ID: NCT04206020

Last Updated: 2022-01-19

Results Overview

Change of Ocular Discomfort Scale, scale ranged from 0 to 4 with 0 = No Discomfort and 4 = Constant Discomfort.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 610 participants
• Primary outcome timeframe: From baseline to Day 57
• Results posted on: 2022-01-19

Participant Flow

Participant milestones

Measure	Placebo Comparator: SkQ1 Vehicle Vehicle for SkQ1 Ophthalmic Solution	SkQ1 Ophthalmic Solution SkQ1 Ophthalmic Solution (1.55µg/mL)
Overall Study STARTED	306	304
Overall Study COMPLETED	298	297
Overall Study NOT COMPLETED	8	7

Reasons for withdrawal

Measure	Placebo Comparator: SkQ1 Vehicle Vehicle for SkQ1 Ophthalmic Solution	SkQ1 Ophthalmic Solution SkQ1 Ophthalmic Solution (1.55µg/mL)
Overall Study Adverse Event	1	4
Overall Study Protocol Violation	2	0
Overall Study Withdrawal by Subject	2	0
Overall Study Lost to Follow-up	2	0
Overall Study Pregnancy	0	1
Overall Study Unable to attend visits	1	2

Baseline Characteristics

Vehicle-Controlled Study of SkQ1 as Treatment for Dry-eye Syndrome

Baseline characteristics by cohort

Measure	Placebo Comparator: SkQ1 Vehicle n=306 Participants Vehicle for SkQ1 Ophthalmic Solution	SkQ1 Ophthalmic Solution n=304 Participants SkQ1 Ophthalmic Solution (1.55µg/mL)	Total n=610 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	166 Participants n=93 Participants	150 Participants n=4 Participants	316 Participants n=27 Participants
Age, Categorical >=65 years	140 Participants n=93 Participants	154 Participants n=4 Participants	294 Participants n=27 Participants
Age, Continuous Mean (SD)	61.9 years STANDARD_DEVIATION 11.92 • n=93 Participants	62.8 years STANDARD_DEVIATION 12.58 • n=4 Participants	62.4 years STANDARD_DEVIATION 12.25 • n=27 Participants
Sex: Female, Male Female	223 Participants n=93 Participants	209 Participants n=4 Participants	432 Participants n=27 Participants
Sex: Female, Male Male	83 Participants n=93 Participants	95 Participants n=4 Participants	178 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	13 Participants n=93 Participants	11 Participants n=4 Participants	24 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Black or African American	50 Participants n=93 Participants	34 Participants n=4 Participants	84 Participants n=27 Participants
Race (NIH/OMB) White	241 Participants n=93 Participants	253 Participants n=4 Participants	494 Participants n=27 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Region of Enrollment United States	306 participants n=93 Participants	304 participants n=4 Participants	610 participants n=27 Participants
Ocular Discomfort Scale	2.7 units on a scale STANDARD_DEVIATION 1.06 • n=93 Participants	2.7 units on a scale STANDARD_DEVIATION 0.98 • n=4 Participants	2.7 units on a scale STANDARD_DEVIATION 1.02 • n=27 Participants

PRIMARY outcome

Timeframe: From baseline to Day 57

Change of Ocular Discomfort Scale, scale ranged from 0 to 4 with 0 = No Discomfort and 4 = Constant Discomfort.

Outcome measures

Measure	Placebo Comparator: SkQ1 Vehicle n=306 Participants Vehicle for SkQ1 Ophthalmic Solution	SkQ1 Ophthalmic Solution n=304 Participants SkQ1 Ophthalmic Solution (1.55µg/mL)
Ocular Discomfort Scale	-0.6 units on a scale Standard Deviation 1.36	-0.6 units on a scale Standard Deviation 1.34

PRIMARY outcome

Timeframe: From baseline to Day 57

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

Outcome measures

Measure	Placebo Comparator: SkQ1 Vehicle n=251 Participants Vehicle for SkQ1 Ophthalmic Solution	SkQ1 Ophthalmic Solution n=250 Participants SkQ1 Ophthalmic Solution (1.55µg/mL)
Conjunctival Fluorescein Staining	-0.63 units on a scale Standard Deviation 1.087	-0.69 units on a scale Standard Deviation 1.150

Adverse Events

Placebo Comparator: SkQ1 Vehicle

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

SkQ1 Ophthalmic Solution

Serious events: 2 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo Comparator: SkQ1 Vehicle n=306 participants at risk Vehicle for SkQ1 Ophthalmic Solution	SkQ1 Ophthalmic Solution n=304 participants at risk SkQ1 Ophthalmic Solution (1.55µg/mL)
Cardiac disorders Atrial fibrillation	0.00% 0/306 • From Day -7 through end of study (Day 57)	0.33% 1/304 • Number of events 1 • From Day -7 through end of study (Day 57)
Cardiac disorders Atrioventricular block complete	0.33% 1/306 • Number of events 1 • From Day -7 through end of study (Day 57)	0.00% 0/304 • From Day -7 through end of study (Day 57)
Gastrointestinal disorders Colitis ischaemic	0.00% 0/306 • From Day -7 through end of study (Day 57)	0.33% 1/304 • Number of events 1 • From Day -7 through end of study (Day 57)
Renal and urinary disorders Nephrolithiasis	0.33% 1/306 • Number of events 1 • From Day -7 through end of study (Day 57)	0.00% 0/304 • From Day -7 through end of study (Day 57)

Other adverse events

Measure	Placebo Comparator: SkQ1 Vehicle n=306 participants at risk Vehicle for SkQ1 Ophthalmic Solution	SkQ1 Ophthalmic Solution n=304 participants at risk SkQ1 Ophthalmic Solution (1.55µg/mL)
General disorders Instillation site pain	4.2% 13/306 • Number of events 18 • From Day -7 through end of study (Day 57)	4.9% 15/304 • Number of events 19 • From Day -7 through end of study (Day 57)
Eye disorders Visual acuity reduced	2.0% 6/306 • Number of events 6 • From Day -7 through end of study (Day 57)	1.6% 5/304 • Number of events 5 • From Day -7 through end of study (Day 57)

Additional Information

Chief Operating Officer

Mitotech S.A.

Phone: +352621692785

Email: info@mitotechpharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER