Trial Outcomes & Findings for Safety and Feasibility of the EyeControl Device (NCT NCT02891629)

NCT ID: NCT02891629

Last Updated: 2019-08-28

Results Overview

Ability to successfully perform at least 70% of device features (controlling the application and Free text features)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 15 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2019-08-28

Participant Flow

Investigator decided to terminate subject participation due to the discovery of cataract during the trial.

Participant milestones

Measure	Device Use in Healthy Volunteers 10 healthy volunteers will be recruited EyeControl device: Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences	Device Use in ALS Patients 5 ALS patients in early stages will be recruited EyeControl device: Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences
Overall Study STARTED	10	5
Overall Study COMPLETED	10	4
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Device Use in Healthy Volunteers n=10 Participants 10 healthy volunteers will be recruited EyeControl device: Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences	Device Use in ALS Patients n=4 Participants 5 ALS patients in early stages will be recruited EyeControl device: Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences	Total n=14 Participants Total of all reporting groups
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Israel	10 participants n=10 Participants	4 participants n=4 Participants	14 participants n=14 Participants
Age, Categorical <=18 years	0 Participants n=10 Participants	0 Participants n=4 Participants	0 Participants n=14 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=10 Participants	4 Participants n=4 Participants	14 Participants n=14 Participants
Age, Categorical >=65 years	0 Participants n=10 Participants	0 Participants n=4 Participants	0 Participants n=14 Participants
Age, Continuous	30.3 years STANDARD_DEVIATION 9.83 • n=10 Participants	46.25 years STANDARD_DEVIATION 5.26 • n=4 Participants	36.6 years STANDARD_DEVIATION 11.35 • n=14 Participants
Sex: Female, Male Female	5 Participants n=10 Participants	0 Participants n=4 Participants	5 Participants n=14 Participants
Sex: Female, Male Male	5 Participants n=10 Participants	4 Participants n=4 Participants	9 Participants n=14 Participants

PRIMARY outcome

Timeframe: 2 weeks

Ability to successfully perform at least 70% of device features (controlling the application and Free text features)

Outcome measures

Measure	Device Use in Healthy Volunteers n=10 Participants 10 healthy volunteers will be recruited EyeControl device: Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences	Device Use in ALS Patients n=4 Participants 5 ALS patients in early stages will be recruited EyeControl device: Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences
Feasibility - Successful Performance Rate of Device Features	4.9 seconds Standard Deviation 1.3	7.2 seconds Standard Deviation 2.2

SECONDARY outcome

Timeframe: 2 weeks

number of device related adverse events reported during the use of the device

Outcome measures

Measure	Device Use in Healthy Volunteers n=10 Participants 10 healthy volunteers will be recruited EyeControl device: Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences	Device Use in ALS Patients n=4 Participants 5 ALS patients in early stages will be recruited EyeControl device: Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences
Safety Assessment - Number of Device Related Adverse Events	2 events	0 events

Adverse Events

Device Use in Healthy Volunteers

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Device Use in ALS Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Device Use in Healthy Volunteers n=10 participants at risk 10 healthy volunteers will be recruited EyeControl device: Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences	Device Use in ALS Patients n=5 participants at risk 5 ALS patients in early stages will be recruited EyeControl device: Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences
Eye disorders Dry Eyes	10.0% 1/10 • Number of events 1 • The adverse events data was collected only during the trial, meaning during the 4 sessions, of about 2.5-3 hours, for each participant, performed over 2 weeks' time. An AE can be any unintended sign, symptom, disease or injury or any untoward clinical signs (including an abnormal laboratory findings) in subjects, users or other persons whether or not related to the investigational medical device.	0.00% 0/5 • The adverse events data was collected only during the trial, meaning during the 4 sessions, of about 2.5-3 hours, for each participant, performed over 2 weeks' time. An AE can be any unintended sign, symptom, disease or injury or any untoward clinical signs (including an abnormal laboratory findings) in subjects, users or other persons whether or not related to the investigational medical device.
Eye disorders Eye Fatigue	10.0% 1/10 • Number of events 1 • The adverse events data was collected only during the trial, meaning during the 4 sessions, of about 2.5-3 hours, for each participant, performed over 2 weeks' time. An AE can be any unintended sign, symptom, disease or injury or any untoward clinical signs (including an abnormal laboratory findings) in subjects, users or other persons whether or not related to the investigational medical device.	0.00% 0/5 • The adverse events data was collected only during the trial, meaning during the 4 sessions, of about 2.5-3 hours, for each participant, performed over 2 weeks' time. An AE can be any unintended sign, symptom, disease or injury or any untoward clinical signs (including an abnormal laboratory findings) in subjects, users or other persons whether or not related to the investigational medical device.

Additional Information

Or Retzkin, CEO

EyeFree Assisting Communication

Phone: +972526490093

Email: or@eyecontrol.co.il

Results disclosure agreements

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