Dry Eye Syndromes
Conditions
Brief summary
This study will evaluate the increase in comfort and comfortable contact lens (CL) wear time associated with application of TrueTear (active intranasal neurostimulation) compared with application of TrueTear sham control (intranasal application which is not electrically active) in symptomatic CL wearers.
Interventions
DEVICETrueTear
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.
DEVICETrueTear Sham Control
TrueTear sham device, which is not electrically active and has limited tip 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.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
A person is eligible for inclusion if he/she * In at least one eye, has a cotton swab nasal stimulation Schirmer test score at least 4 mm greater than 3 minute Schirmer with anesthesia basal score in the same eye at the Screening Visit * Is an adapted soft contact lens wearer and currently wears lenses an average of at least 2 days per week, with an average minimum wearing time of 3 hours each day over the past month and is able and willing to wear lenses for at least 6 hours on four study day visits * Has at least 20/40 visual acuity in both eyes with CL correction * Is symptomatic according to Young's categorization
Exclusion criteria
* Refractive error surgery * Chronic or recurrent epistaxis, coagulation disorders or other conditions that may increase the risk of bleeding * History of nasal or sinus surgery * Vascularized polyp, deviated septum or severe nasal airway obstruction at the Screening visit * Cardiac demand pacemaker, implanted defibrillator, or other active implanted metallic or active implanted electronic device in the head
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score in the Study Eye | Day 28 | 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. |
| Comfort Rating Score in the Study Eye | CL Insertion, After 2 hours and the End of Day on Day 24 | 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. |
| Comfortable Wear Time (CWT) in the Study Eye | Day 24 | 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. |
| Total Wear Time (Total WT) in the Study Eye | Day 24 | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TrueTear 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. | 42 |
| 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. | 42 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 0 |
Baseline characteristics
| Characteristic | TrueTear | TrueTear Sham Control | Total |
|---|---|---|---|
| Age, Continuous | 29 years STANDARD_DEVIATION 9 | 27 years STANDARD_DEVIATION 9 | 28 years STANDARD_DEVIATION 9 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 35 Participants | 32 Participants | 67 Participants |
| Sex: Female, Male Male | 7 Participants | 10 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 42 |
| other Total, other adverse events | 3 / 42 | 4 / 42 |
| serious Total, serious adverse events | 0 / 42 | 0 / 42 |
Outcome results
Primary
Comfortable Wear Time (CWT) in the Study Eye
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.
Time frame: Day 24
Population: All eligible participants with data available for analysis at the given time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TrueTear | Comfortable Wear Time (CWT) in the Study Eye | 618 minutes | Standard Deviation 272 |
| TrueTear Sham Control | Comfortable Wear Time (CWT) in the Study Eye | 574 minutes | Standard Deviation 254 |
p-value: 0.488t-test, 2 sided
Primary
Comfort Rating Score in the Study Eye
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TrueTear | Comfort Rating Score in the Study Eye | Insertion | 88 score on a scale | Standard Deviation 11 |
| TrueTear | Comfort Rating Score in the Study Eye | After 2 hours | 86 score on a scale | Standard Deviation 11 |
| TrueTear | Comfort Rating Score in the Study Eye | End of Day 24 | 75 score on a scale | Standard Deviation 17 |
| TrueTear Sham Control | Comfort Rating Score in the Study Eye | Insertion | 86 score on a scale | Standard Deviation 16 |
| TrueTear Sham Control | Comfort Rating Score in the Study Eye | After 2 hours | 82 score on a scale | Standard Deviation 17 |
| TrueTear Sham Control | Comfort Rating Score in the Study Eye | End of Day 24 | 69 score on a scale | Standard Deviation 19 |
Comparison: Insertionp-value: 0.468t-test, 2 sided
Comparison: After 2 hoursp-value: 0.235t-test, 2 sided
Comparison: End of Dayp-value: 0.152t-test, 2 sided
Primary
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score in the Study Eye
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.
Time frame: Day 28
Population: All eligible participants with data available for analysis at the given time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TrueTear | Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score in the Study Eye | 15.3 score on a scale | Standard Deviation 5.6 |
| TrueTear Sham Control | Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score in the Study Eye | 17.2 score on a scale | Standard Deviation 5.2 |
p-value: 0.116Independent t-test
Primary
Total Wear Time (Total WT) in the Study Eye
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.
Time frame: Day 24
Population: All eligible participants with data available for analysis at the given time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TrueTear | Total Wear Time (Total WT) in the Study Eye | 747 minutes | Standard Deviation 201 |
| TrueTear Sham Control | Total Wear Time (Total WT) in the Study Eye | 652 minutes | Standard Deviation 233 |
p-value: 0.072t-test, 2 sided