Dry Eye
Conditions
Brief summary
The purpose of this study to evaluate changes in comfort and dryness in symptomatic contact lens (CL) wearers after using Xiidra (lifitegrast 5.0% ophthalmic solution) for 12 weeks.
Interventions
DRUGXiidra
Xiidra (lifitegrast 5% ophthalmic solution)
Sponsors
Novartis
University of Waterloo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Is at least 18 years of age and has full legal capacity to volunteer; 2. Has read and signed an information consent letter; 3. Is willing and able to follow instructions and maintain the appointment schedule; 4. Currently wears daily, soft, frequent replacement lenses (daily, bi-weekly or monthly disposable lenses) in both eyes, that are available in Canada, for a minimum of 5 days/week for 6 hours/day over the last month, and is willing to continue to do so during the study; 5. Is a symptomatic CL wearer as determined by Eye Dryness Score4,5 (EDS) ≥40 at the end of the wear day AND according to the classification by Young et al7; 6. Can achieve acceptable lens fit as well as visual acuity (VA) correctable to logMAR +0.20 or better in each eye with their habitual contact lens type; 7. Has a history of artificial tear or rewetting drop use at least once in the last 30 days; 8. Is willing to use the Xiidra study drops twice a day on a daily basis (irrespective of CL wear) and to stop use of any habitual rewetting drops and/or artificial tears over the course of the 12-week treatment phase;
Exclusion criteria
1. Is participating in any concurrent clinical or research study; 2. Is wearing soft CLs on an extended wear basis (i.e. overnight) or is a rigid gas permeable lens or hybrid lens wearer; 3. Has a known sensitivity to the investigational product or diagnostic substances (e.g. fluorescein) to be used in the study; 4. Has any known ocular disease and/or infection, that's either currently active\* or has occurred within the previous 30 days; 5. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable (examples may include active or uncontrolled systemic conditions such as allergies, autoimmune disease or immunodeficiency disease); 6. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable, including but not limited to topical cyclosporine, any other topical ophthalmic medication, antihistamines, and aspirin; 7. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by self-report);\*\* 8. Has undergone refractive error surgery such as LASIK within the last 12 months; 9. Has a history of yttrium-aluminium-garnet laser posterior capsulotomy within the previous 6 months, 10. Is an employee of the Centre for Ocular Research & Education; \* For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Contact Lens-related Discomfort at 12 Weeks Compared to Baseline | Baseline and 12 weeks | Participants rate their contact lens-related discomfort on a scale from 0 (no discomfort) to 100 (maximal discomfort). |
| Difference in Contact Lens-related Dryness at 12 Weeks Compared to Baseline | Baseline and 12 weeks | Participants rate their contact lens-related dryness on a scale from 0 (no discomfort) to 100 (maximal discomfort). |
Countries
Canada
Participant flow
Recruitment details
Participants were recruited at a single site between July 2021 and April 2024. The first participant was enrolled on July 7, 2021 and the last participant was enrolled January 19, 2024.
Pre-assignment details
Out of the 45 participants that were enrolled, 43 met the inclusion critieria, and 42 were dispensed with the study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Xiidra Treatment Each participant will use the same study drops, Xiidra, over the course of the 12-week study.
Xiidra: Xiidra (lifitegrast 5% ophthalmic solution) | 43 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Xiidra Treatment | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 1 Participants | — |
| Age, Categorical Between 18 and 65 years | 42 Participants | — |
| Age, Continuous | 30.7 years STANDARD_DEVIATION 11.8 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Canada | 43 participants | — |
| Sex: Female, Male Female | 36 Participants | — |
| Sex: Female, Male Male | 7 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 42 | 1 / 43 | 0 / 43 |
| other Total, other adverse events | 3 / 42 | 6 / 42 | 1 / 43 | 0 / 43 |
| serious Total, serious adverse events | 0 / 42 | 0 / 42 | 0 / 43 | 0 / 43 |
Outcome results
Primary
Difference in Contact Lens-related Discomfort at 12 Weeks Compared to Baseline
Participants rate their contact lens-related discomfort on a scale from 0 (no discomfort) to 100 (maximal discomfort).
Time frame: Baseline and 12 weeks
Population: 2 participants discontinued before the study could be completed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Xiidra Treatment | Difference in Contact Lens-related Discomfort at 12 Weeks Compared to Baseline | Baseline | 71 score on a scale |
| Xiidra Treatment | Difference in Contact Lens-related Discomfort at 12 Weeks Compared to Baseline | 12 Weeks | 11 score on a scale |
p-value: <0.01Wilcoxon (Mann-Whitney)
Primary
Difference in Contact Lens-related Dryness at 12 Weeks Compared to Baseline
Participants rate their contact lens-related dryness on a scale from 0 (no discomfort) to 100 (maximal discomfort).
Time frame: Baseline and 12 weeks
Population: 2 participants discontinued before the study could be completed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Xiidra Treatment | Difference in Contact Lens-related Dryness at 12 Weeks Compared to Baseline | Baseline | 75 score on a scale |
| Xiidra Treatment | Difference in Contact Lens-related Dryness at 12 Weeks Compared to Baseline | 12 Weeks | 15 score on a scale |
p-value: <0.01Wilcoxon (Mann-Whitney)