Dry Eye
Conditions
Keywords
Dry Eye, Soft Contact Lenses
Brief summary
This is a prospective, single site, randomized, double masked, comparator-controlled study designed to evaluate the efficacy of lifitegrast ophthalmic solution 5% in treating the symptoms of dry eye in soft contact lens wearers as compared to control. We hypothesize that there will be a significant improvement in dry eye symptoms in contact lens wearers using lifitegrast as compared to those being treated with control (lifitegrast vehicle).
Interventions
Dosed twice a day for 8 weeks
OTHERLifitegrast Ophthalmic Solution Vehicle
Dosed twice a day for 8 weeks
Sponsors
Novartis Pharmaceuticals
Bausch & Lomb Incorporated
State University of New York College of Optometry
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects must read, understand and sign the Statement of Informed Consent 2. Subjects must be at least 18 years of age 3. Subjects must be habitual soft contact lens (CL) wearers, with a daily, weekly, bi- weekly or monthly replacement schedule 4. Habitual contact lenses must have a suitable fit as determined by the investigator 5. Subjects must report a history of dry eye symptoms, for which they have used rewetting drops or Artificial Tears (ATs) in the past 30 days 6. Subjects must be willing to discontinue the use of Artificial Tears (ATs) and rewetting drops for the duration of the study 7. Subjects must have a score of 12 or higher on the CLDEQ (Contact Lens Dry Eye Questionnaire-8) at baseline 8. Subjects must have at least 2 of the following signs of dry eye disease: 1. High tear osmolarity \> 308 mOsm/L, (milliosmoles per liter) or a difference greater than 8 mOsm/L between eyes 2. Any corneal staining 3. Any bulbar conjunctival staining 4. Low TBUT (tear break up time) (\<10s) 5. Schirmer \<10mm in either eye 9. Subjects must be able to read at least half of the 20/25 (via entrance Snellen visual acuity) or better in each eye in their current contact lens prescription. 10. Subjects currently wearing reusable contact lenses must be willing to use Clear Care solution for cleaning and disinfecting throughout the study.
Exclusion criteria
1. Currently pregnant or breastfeeding by self-report 2. Allergy to lifitegrast ophthalmic solution 5% (Xiidra) 3. Habitual extended wear contact lens schedule 4. Any active ocular disease that may affect the ocular surface other than dry eye (significant blepharitis, allergic conjunctivitis, lagophthalmos, chalazia, hordeolum etc.) 5. Any meibomian gland dysfunction, blepharitis, corneal neovascularization or papillary conjunctivitis that is grade 3 or higher using the Efron Grading Scale. 6. Excessive corneal staining, that in the opinion of the investigator, is a contraindication to contact lens use. 7. History of ocular surgery 8. Any active ocular infection 9. Use of any topical ophthalmic medications other than artificial tears or rewetting drops 10. Inability to perform necessary visual function assessments 11. Punctal plug insertion in the last 3 months, or presence of punctal plugs at the time of the exam.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Lifitegrast Ophthalmic Solution 5% in Treating the Symptoms of Dry Eye in Contact Lens Wearers as Measured by Change in Total CLDEQ-8 Score From Baseline to Week 8 | 8 weeks | Measured by change in total score on the CLDEQ-8 (Contact Lens Dry Eye Questionnaire) in subjects using lifitegrast ophthalmic solution as compared to subjects using lifitegrast ophthalmic solution vehicle from baseline to week 8. The CLDEQ-8 (Contact Lens Dry Eye Questionnaire) is a symptom questionnaire that assesses discomfort related to dry eye in contact lens wearers. The minimum possible CLDEQ-8 score is 0. The maximum possible CLDEQ-8 score is 37. Therefore, the maximum change is +/- 37. A negative change is an improvement in symptoms (a lower score at week 8 than baseline). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Score on the CLDEQ- 8 From Baseline to 4 Weeks | 4 weeks | Measured by change in total score on the CLDEQ-8 (Contact Lens Dry Eye Questionnaire) in subjects using lifitegrast ophthalmic solution as compared to subjects using lifitegrast ophthalmic solution vehicle from baseline to week 4. The CLDEQ-8 (Contact Lens Dry Eye Questionnaire) is a symptom questionnaire that assesses discomfort related to dry eye in contact lens wearers. The minimum possible CLDEQ-8 score is 0. The maximum possible CLDEQ-8 score is 37. Therefore, the maximum change is +/- 37. A negative change is an improvement in symptoms (a lower score at week 4 than baseline). |
| Change in Tear Osmolarity OD (Right Eye) From Baseline to Week 8 | 8 weeks | Change in tear osmolarity (as measured by the TearLab device) from baseline to week 8 in the lifitegrast 5% group compared to subjects using lifitegrast ophthalmic solution vehicle. Measured in mOsm/L. A negative change is a lower osmolarity at week 8, which would be an improvement. |
| Change in Total Score on the CLDEQ- 8 From Baseline to 2 Weeks | 2 weeks | Measured by change in total score on the CLDEQ-8 (Contact Lens Dry Eye Questionnaire) in subjects using lifitegrast ophthalmic solution as compared to subjects using lifitegrast ophthalmic solution vehicle from baseline to week 2. The CLDEQ-8 (Contact Lens Dry Eye Questionnaire) is a symptom questionnaire that assesses discomfort related to dry eye in contact lens wearers. The minimum possible CLDEQ-8 score is 0. The maximum possible CLDEQ-8 score is 37. Therefore, the maximum change is +/- 37. A negative change is an improvement in symptoms (a lower score at week 2 than baseline). |
| Forced Choice Questionnaire | 8 weeks | Forced choice questionnaire asking if the participant felt that their symptoms improved to the point that they would continue treatment outside of the study |
| Change in Score for Each Question on the CLDEQ-8 From Baseline to Week 8 | 8 weeks | Measured by change in score for each Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) question in subjects using lifitegrast ophthalmic solution compared to subjects using lifitegrast ophthalmic solution vehicle. A negative change for a question from baseline to week 8 is an improvement in symptom frequency or intensity. Questions are for the past 2 weeks. Questions 1a, 2a, 3a & 4 ask about frequency of eye discomfort when wearing contacts, eye dryness, changeable, blurry vision in contacts and wanting to close your eyes. Scale: 0=Never, 1=Rarely, 2=Sometimes, 3=Frequently, 4=Constantly Questions 1b, 2b & 3b ask about the intensity of symptoms at the end of contact lens wearing time noted for questions 1a, 2a and 3a. Scale: 0-5, 0=Never have it, 5=Very Intense Question 5 asks how often did your eyes bother you so much that you felt you needed to take out your contact lenses. Scale: 1=Never, 2=Less than once a week, 3=Weekly, 4=Several times a week, 5=Daily, 6=Several times a day |
| Change in Tear Osmolarity OS (Left Eye) From Baseline to Week 8 | 8 weeks | Change in tear osmolarity (as measured by the TearLab device) from baseline to week 8 in the lifitegrast 5% group compared to subjects using lifitegrast ophthalmic solution vehicle. Measured in mOsm/L. A negative change is a lower osmolarity at week 8, which would be an improvement. |
Countries
United States
Participant flow
Pre-assignment details
2 subjects were enrolled in the study but not randomized due to screen failure
Participants by arm
| Arm | Count |
|---|---|
| Lifitegrast Ophthalmic Solution Vehicle Lifitegrast Ophthalmic Solution Vehicle: Dosed twice a day for 8 weeks | 15 |
| Lifitegrast Ophthalmic Solution 5% Lifitegrast 5% Ophthalmic Solution: Dosed twice a day for 8 weeks | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Lifitegrast Ophthalmic Solution Vehicle | Lifitegrast Ophthalmic Solution 5% | Total |
|---|---|---|---|
| Age, Continuous | 26.27 years STANDARD_DEVIATION 4.57 | 27.20 years STANDARD_DEVIATION 5.97 | 26.73 years STANDARD_DEVIATION 5.25 |
| CLDEQ8 Total Score | 21 units on a scale | 22 units on a scale | 21 units on a scale |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 15 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 8 Participants | 15 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 6 Participants | 12 Participants |
| Region of Enrollment United States | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 14 Participants | 13 Participants | 27 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 5 / 15 | 12 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Efficacy of Lifitegrast Ophthalmic Solution 5% in Treating the Symptoms of Dry Eye in Contact Lens Wearers as Measured by Change in Total CLDEQ-8 Score From Baseline to Week 8
Measured by change in total score on the CLDEQ-8 (Contact Lens Dry Eye Questionnaire) in subjects using lifitegrast ophthalmic solution as compared to subjects using lifitegrast ophthalmic solution vehicle from baseline to week 8. The CLDEQ-8 (Contact Lens Dry Eye Questionnaire) is a symptom questionnaire that assesses discomfort related to dry eye in contact lens wearers. The minimum possible CLDEQ-8 score is 0. The maximum possible CLDEQ-8 score is 37. Therefore, the maximum change is +/- 37. A negative change is an improvement in symptoms (a lower score at week 8 than baseline).
Time frame: 8 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lifitegrast Ophthalmic Solution Vehicle | Efficacy of Lifitegrast Ophthalmic Solution 5% in Treating the Symptoms of Dry Eye in Contact Lens Wearers as Measured by Change in Total CLDEQ-8 Score From Baseline to Week 8 | -4 units on a scale |
| Lifitegrast Ophthalmic Solution 5% | Efficacy of Lifitegrast Ophthalmic Solution 5% in Treating the Symptoms of Dry Eye in Contact Lens Wearers as Measured by Change in Total CLDEQ-8 Score From Baseline to Week 8 | -5 units on a scale |
p-value: 0.69Wilcoxon (Mann-Whitney)
Secondary
Change in Score for Each Question on the CLDEQ-8 From Baseline to Week 8
Measured by change in score for each Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) question in subjects using lifitegrast ophthalmic solution compared to subjects using lifitegrast ophthalmic solution vehicle. A negative change for a question from baseline to week 8 is an improvement in symptom frequency or intensity. Questions are for the past 2 weeks. Questions 1a, 2a, 3a & 4 ask about frequency of eye discomfort when wearing contacts, eye dryness, changeable, blurry vision in contacts and wanting to close your eyes. Scale: 0=Never, 1=Rarely, 2=Sometimes, 3=Frequently, 4=Constantly Questions 1b, 2b & 3b ask about the intensity of symptoms at the end of contact lens wearing time noted for questions 1a, 2a and 3a. Scale: 0-5, 0=Never have it, 5=Very Intense Question 5 asks how often did your eyes bother you so much that you felt you needed to take out your contact lenses. Scale: 1=Never, 2=Less than once a week, 3=Weekly, 4=Several times a week, 5=Daily, 6=Several times a day
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Lifitegrast Ophthalmic Solution Vehicle | Change in Score for Each Question on the CLDEQ-8 From Baseline to Week 8 | Question 1A Change | -1 units on a scale |
| Lifitegrast Ophthalmic Solution Vehicle | Change in Score for Each Question on the CLDEQ-8 From Baseline to Week 8 | Question 1B Change | -1 units on a scale |
| Lifitegrast Ophthalmic Solution Vehicle | Change in Score for Each Question on the CLDEQ-8 From Baseline to Week 8 | Question 2A Change | -1 units on a scale |
| Lifitegrast Ophthalmic Solution Vehicle | Change in Score for Each Question on the CLDEQ-8 From Baseline to Week 8 | Question 2B Change | -1 units on a scale |
| Lifitegrast Ophthalmic Solution Vehicle | Change in Score for Each Question on the CLDEQ-8 From Baseline to Week 8 | Question 3A Change | 0 units on a scale |
| Lifitegrast Ophthalmic Solution Vehicle | Change in Score for Each Question on the CLDEQ-8 From Baseline to Week 8 | Question 3B Change | 0 units on a scale |
| Lifitegrast Ophthalmic Solution Vehicle | Change in Score for Each Question on the CLDEQ-8 From Baseline to Week 8 | Question 4 Change | 0 units on a scale |
| Lifitegrast Ophthalmic Solution Vehicle | Change in Score for Each Question on the CLDEQ-8 From Baseline to Week 8 | Question 5 Change | -1 units on a scale |
| Lifitegrast Ophthalmic Solution 5% | Change in Score for Each Question on the CLDEQ-8 From Baseline to Week 8 | Question 5 Change | -1 units on a scale |
| Lifitegrast Ophthalmic Solution 5% | Change in Score for Each Question on the CLDEQ-8 From Baseline to Week 8 | Question 1A Change | -1 units on a scale |
| Lifitegrast Ophthalmic Solution 5% | Change in Score for Each Question on the CLDEQ-8 From Baseline to Week 8 | Question 3A Change | 0 units on a scale |
| Lifitegrast Ophthalmic Solution 5% | Change in Score for Each Question on the CLDEQ-8 From Baseline to Week 8 | Question 1B Change | -1 units on a scale |
| Lifitegrast Ophthalmic Solution 5% | Change in Score for Each Question on the CLDEQ-8 From Baseline to Week 8 | Question 4 Change | -1 units on a scale |
| Lifitegrast Ophthalmic Solution 5% | Change in Score for Each Question on the CLDEQ-8 From Baseline to Week 8 | Question 2A Change | -1 units on a scale |
| Lifitegrast Ophthalmic Solution 5% | Change in Score for Each Question on the CLDEQ-8 From Baseline to Week 8 | Question 3B Change | 0 units on a scale |
| Lifitegrast Ophthalmic Solution 5% | Change in Score for Each Question on the CLDEQ-8 From Baseline to Week 8 | Question 2B Change | -1 units on a scale |
Comparison: Question 5 change from baseline to week 8 in lifitegrast vs vehicle groupsp-value: 0.69Wilcoxon (Mann-Whitney)
Comparison: Question 1a Change from baseline to week 8 in lifitegrast vs vehiclep-value: 0.62Wilcoxon (Mann-Whitney)
Comparison: Question 1b change from baseline to week 8 in lifitegrast vs vehicle groupsp-value: 0.53Wilcoxon (Mann-Whitney)
Comparison: Question 2a change from baseline to week 8 in lifitegrast vs vehicle groupsp-value: 0.66Wilcoxon (Mann-Whitney)
Comparison: Question 2b change from baseline to week 8 in lifitegrast vs vehicle groupsp-value: 0.81Wilcoxon (Mann-Whitney)
Comparison: Question 3a change from baseline to week 8 in lifitegrast vs vehicle groupsp-value: >0.999Wilcoxon (Mann-Whitney)
Comparison: Question 3b change from baseline to week 8 in lifitegrast vs vehicle groupsp-value: 0.47Wilcoxon (Mann-Whitney)
Comparison: Question 4 change from baseline to week 8 in lifitegrast vs vehicle groupsp-value: 0.52Wilcoxon (Mann-Whitney)
Secondary
Change in Tear Osmolarity OD (Right Eye) From Baseline to Week 8
Change in tear osmolarity (as measured by the TearLab device) from baseline to week 8 in the lifitegrast 5% group compared to subjects using lifitegrast ophthalmic solution vehicle. Measured in mOsm/L. A negative change is a lower osmolarity at week 8, which would be an improvement.
Time frame: 8 weeks
Population: Note that data is missing for 2 subjects in the lifitegrast group due to issues with calibrating the TearLab device on the day of their visits.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lifitegrast Ophthalmic Solution Vehicle | Change in Tear Osmolarity OD (Right Eye) From Baseline to Week 8 | -1 mOsm/L (milliosmoles/liter) |
| Lifitegrast Ophthalmic Solution 5% | Change in Tear Osmolarity OD (Right Eye) From Baseline to Week 8 | -1 mOsm/L (milliosmoles/liter) |
p-value: 0.84Wilcoxon (Mann-Whitney)
Secondary
Change in Tear Osmolarity OS (Left Eye) From Baseline to Week 8
Change in tear osmolarity (as measured by the TearLab device) from baseline to week 8 in the lifitegrast 5% group compared to subjects using lifitegrast ophthalmic solution vehicle. Measured in mOsm/L. A negative change is a lower osmolarity at week 8, which would be an improvement.
Time frame: 8 weeks
Population: Note that data is missing for 2 subjects in the lifitegrast group due to issues with calibrating the TearLab device on the day of their visits.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lifitegrast Ophthalmic Solution Vehicle | Change in Tear Osmolarity OS (Left Eye) From Baseline to Week 8 | 6 mOsm/L |
| Lifitegrast Ophthalmic Solution 5% | Change in Tear Osmolarity OS (Left Eye) From Baseline to Week 8 | 0 mOsm/L |
p-value: 0.68Wilcoxon (Mann-Whitney)
Secondary
Change in Total Score on the CLDEQ- 8 From Baseline to 2 Weeks
Measured by change in total score on the CLDEQ-8 (Contact Lens Dry Eye Questionnaire) in subjects using lifitegrast ophthalmic solution as compared to subjects using lifitegrast ophthalmic solution vehicle from baseline to week 2. The CLDEQ-8 (Contact Lens Dry Eye Questionnaire) is a symptom questionnaire that assesses discomfort related to dry eye in contact lens wearers. The minimum possible CLDEQ-8 score is 0. The maximum possible CLDEQ-8 score is 37. Therefore, the maximum change is +/- 37. A negative change is an improvement in symptoms (a lower score at week 2 than baseline).
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifitegrast Ophthalmic Solution Vehicle | Change in Total Score on the CLDEQ- 8 From Baseline to 2 Weeks | -3.2 units on a scale | Standard Deviation 3.9 |
| Lifitegrast Ophthalmic Solution 5% | Change in Total Score on the CLDEQ- 8 From Baseline to 2 Weeks | -3.93 units on a scale | Standard Deviation 4.96 |
p-value: 0.66t-test, 2 sided
Secondary
Change in Total Score on the CLDEQ- 8 From Baseline to 4 Weeks
Measured by change in total score on the CLDEQ-8 (Contact Lens Dry Eye Questionnaire) in subjects using lifitegrast ophthalmic solution as compared to subjects using lifitegrast ophthalmic solution vehicle from baseline to week 4. The CLDEQ-8 (Contact Lens Dry Eye Questionnaire) is a symptom questionnaire that assesses discomfort related to dry eye in contact lens wearers. The minimum possible CLDEQ-8 score is 0. The maximum possible CLDEQ-8 score is 37. Therefore, the maximum change is +/- 37. A negative change is an improvement in symptoms (a lower score at week 4 than baseline).
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifitegrast Ophthalmic Solution Vehicle | Change in Total Score on the CLDEQ- 8 From Baseline to 4 Weeks | -3.53 units on a scale | Standard Deviation 5.18 |
| Lifitegrast Ophthalmic Solution 5% | Change in Total Score on the CLDEQ- 8 From Baseline to 4 Weeks | -5.6 units on a scale | Standard Deviation 3.96 |
p-value: 0.23t-test, 2 sided
Secondary
Forced Choice Questionnaire
Forced choice questionnaire asking if the participant felt that their symptoms improved to the point that they would continue treatment outside of the study
Time frame: 8 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lifitegrast Ophthalmic Solution Vehicle | Forced Choice Questionnaire | Yes they would continue treatment | 8 Participants |
| Lifitegrast Ophthalmic Solution Vehicle | Forced Choice Questionnaire | No they would not continue treatment | 7 Participants |
| Lifitegrast Ophthalmic Solution 5% | Forced Choice Questionnaire | Yes they would continue treatment | 4 Participants |
| Lifitegrast Ophthalmic Solution 5% | Forced Choice Questionnaire | No they would not continue treatment | 11 Participants |
p-value: 0.14Chi-squared