Trial Outcomes & Findings for Clinical Trial to Evaluate the Symptoms in Symptomatic Contact Lens Wearers Following Application of Intranasal Tear Neurostimulator Versus Control (NCT NCT03325673)

Results Overview

The CLDEQ-8 is a validated questionnaire used to quantify symptoms experienced by the contact lenses (CLs) wearer. The participants were asked to respond to 8 questions about how their CLs performed over the preceding 2-week period. 4 questions (Eye discomfort, Eye dryness, Changeable blurry vision and Closing your eyes) answered on a scale of 0=Never to 4=Constantly; 3 questions about the end of wearing time (Discomfort, Dryness, Changeable blurry vision) answered on a scale of 0=Never have it to 5=Very Intense and 1 question (Removing your lenses) on a scale of 1=Never to 6=Several times a day for a total possible score of 1(best) to 37 (worst). The study eye was defined as the qualified eye with the greatest increase in tear production with stimulation by a cotton swab at the Screening Visit. If both eyes qualified, then the right eye was designated as the study eye.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

84 participants

Primary outcome timeframe

Day 28

Results posted on

2019-12-18

Participant Flow

Participant milestones

Participant milestones
Measure	TrueTear TrueTear Device (Intranasal Tear Neurostimulator) was used intranasally on contact lens (CL) wear days; it was also used on non-CL wear days if the participant chose. The number of applications was determined by participant.	TrueTear Sham Control TrueTear sham device, which is not electrically active and has limited insertion depth, was used intranasally on CL wear days; it was also used on non-CL wear days if participant chose. The number of applications was determined by participant.
Overall Study STARTED	42	42
Overall Study COMPLETED	38	42
Overall Study NOT COMPLETED	4	0

Reasons for withdrawal

Reasons for withdrawal
Measure	TrueTear TrueTear Device (Intranasal Tear Neurostimulator) was used intranasally on contact lens (CL) wear days; it was also used on non-CL wear days if the participant chose. The number of applications was determined by participant.	TrueTear Sham Control TrueTear sham device, which is not electrically active and has limited insertion depth, was used intranasally on CL wear days; it was also used on non-CL wear days if participant chose. The number of applications was determined by participant.
Overall Study Adverse Event	4	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TrueTear n=42 Participants TrueTear Device (Intranasal Tear Neurostimulator) was used intranasally on CL wear days; it was also used on non-CL wear days if the participant chose. The number of applications was determined by participant.	TrueTear Sham Control n=42 Participants TrueTear sham device, which is not electrically active and has limited insertion depth, was used intranasally on CL wear days; it was also used on non-CL wear days if participant chose. The number of applications was determined by participant.	Total n=84 Participants Total of all reporting groups
Age, Continuous	29 years STANDARD_DEVIATION 9 • n=42 Participants	27 years STANDARD_DEVIATION 9 • n=42 Participants	28 years STANDARD_DEVIATION 9 • n=84 Participants
Sex: Female, Male Female	35 Participants n=42 Participants	32 Participants n=42 Participants	67 Participants n=84 Participants
Sex: Female, Male Male	7 Participants n=42 Participants	10 Participants n=42 Participants	17 Participants n=84 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Day 28

Population: All eligible participants with data available for analysis at the given time-point.

The CLDEQ-8 is a validated questionnaire used to quantify symptoms experienced by the contact lenses (CLs) wearer. The participants were asked to respond to 8 questions about how their CLs performed over the preceding 2-week period. 4 questions (Eye discomfort, Eye dryness, Changeable blurry vision and Closing your eyes) answered on a scale of 0=Never to 4=Constantly; 3 questions about the end of wearing time (Discomfort, Dryness, Changeable blurry vision) answered on a scale of 0=Never have it to 5=Very Intense and 1 question (Removing your lenses) on a scale of 1=Never to 6=Several times a day for a total possible score of 1(best) to 37 (worst). The study eye was defined as the qualified eye with the greatest increase in tear production with stimulation by a cotton swab at the Screening Visit. If both eyes qualified, then the right eye was designated as the study eye.

Outcome measures

Outcome measures
Measure	TrueTear n=38 Participants TrueTear Device (Intranasal Tear Neurostimulator) was used intranasally on CL wear days; it was also used on non-CL wear days if the participant chose. The number of applications was determined by participant.	TrueTear Sham Control n=40 Participants TrueTear sham device, which is not electrically active and has limited insertion depth, was used intranasally on CL wear days; it was also used on non-CL wear days if participant chose. The number of applications was determined by participant.
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score in the Study Eye	15.3 score on a scale Standard Deviation 5.6	17.2 score on a scale Standard Deviation 5.2

PRIMARY outcome

Timeframe: CL Insertion, After 2 hours and the End of Day on Day 24

Population: All eligible participants with data available for analysis at the given time-point.

The participant assessed contact lens comfort in the study eye using a 100 point scale where a score of 0=Extremely uncomfortable and a score of 100=Extremely comfortable. The study eye was defined as the qualified eye with the greatest increase in tear production with stimulation by a cotton swab at the Screening Visit. If both eyes qualified, then the right eye was designated as the study eye.

Outcome measures

Outcome measures
Measure	TrueTear n=38 Participants TrueTear Device (Intranasal Tear Neurostimulator) was used intranasally on CL wear days; it was also used on non-CL wear days if the participant chose. The number of applications was determined by participant.	TrueTear Sham Control n=40 Participants TrueTear sham device, which is not electrically active and has limited insertion depth, was used intranasally on CL wear days; it was also used on non-CL wear days if participant chose. The number of applications was determined by participant.
Comfort Rating Score in the Study Eye Insertion	88 score on a scale Standard Deviation 11	86 score on a scale Standard Deviation 16
Comfort Rating Score in the Study Eye After 2 hours	86 score on a scale Standard Deviation 11	82 score on a scale Standard Deviation 17
Comfort Rating Score in the Study Eye End of Day 24	75 score on a scale Standard Deviation 17	69 score on a scale Standard Deviation 19

PRIMARY outcome

Timeframe: Day 24

Population: All eligible participants with data available for analysis at the given time-point.

CWT was calculated by taking the difference between the time participants reported started to find their CLs getting uncomfortable and the reported insertion time for that day. The study eye was defined as the qualified eye with the greatest increase in tear production with stimulation by a cotton swab at the Screening Visit. If both eyes qualified, then the right eye was designated as the study eye.

Outcome measures

Outcome measures
Measure	TrueTear n=34 Participants TrueTear Device (Intranasal Tear Neurostimulator) was used intranasally on CL wear days; it was also used on non-CL wear days if the participant chose. The number of applications was determined by participant.	TrueTear Sham Control n=36 Participants TrueTear sham device, which is not electrically active and has limited insertion depth, was used intranasally on CL wear days; it was also used on non-CL wear days if participant chose. The number of applications was determined by participant.
Comfortable Wear Time (CWT) in the Study Eye	618 minutes Standard Deviation 272	574 minutes Standard Deviation 254

PRIMARY outcome

Timeframe: Day 24

Population: All eligible participants with data available for analysis at the given time-point.

Total WT was calculated by taking the difference between the time participants reported removing their CLs and the reported insertion time for that day. The study eye was defined as the qualified eye with the greatest increase in tear production with stimulation by a cotton swab at the Screening Visit. If both eyes qualified, then the right eye was designated as the study eye.

Outcome measures

Outcome measures
Measure	TrueTear n=34 Participants TrueTear Device (Intranasal Tear Neurostimulator) was used intranasally on CL wear days; it was also used on non-CL wear days if the participant chose. The number of applications was determined by participant.	TrueTear Sham Control n=36 Participants TrueTear sham device, which is not electrically active and has limited insertion depth, was used intranasally on CL wear days; it was also used on non-CL wear days if participant chose. The number of applications was determined by participant.
Total Wear Time (Total WT) in the Study Eye	747 minutes Standard Deviation 201	652 minutes Standard Deviation 233

Adverse Events

TrueTear

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

TrueTear Sham Control

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	TrueTear n=42 participants at risk TrueTear Device (Intranasal Tear Neurostimulator) was used intranasally on CL wear days; it was also used on non-CL wear days if the participant chose. The number of applications was determined by participant.	TrueTear Sham Control n=42 participants at risk TrueTear sham device, which is not electrically active and has limited insertion depth, was used intranasally on CL wear days; it was also used on non-CL wear days if participant chose. The number of applications was determined by participant.
Respiratory, thoracic and mediastinal disorders Nasopharyngitis	2.4% 1/42 • Day 0 to Day 28 +/- 3 days	7.1% 3/42 • Day 0 to Day 28 +/- 3 days
Nervous system disorders Headache	7.1% 3/42 • Day 0 to Day 28 +/- 3 days	2.4% 1/42 • Day 0 to Day 28 +/- 3 days

Additional Information

Therapeutic Area Head

Allergan

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER