Trial Outcomes & Findings for Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers (NCT NCT05505292)
NCT ID: NCT05505292
Last Updated: 2025-01-14
Results Overview
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).
COMPLETED
PHASE4
32 participants
8 weeks
2025-01-14
Participant Flow
2 subjects were enrolled in the study but not randomized due to screen failure
Participant milestones
| Measure |
Lifitegrast Ophthalmic Solution Vehicle
Lifitegrast Ophthalmic Solution Vehicle: Dosed twice a day for 8 weeks
|
Lifitegrast Ophthalmic Solution 5%
Lifitegrast 5% Ophthalmic Solution: Dosed twice a day for 8 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers
Baseline characteristics by cohort
| Measure |
Lifitegrast Ophthalmic Solution Vehicle
n=15 Participants
Lifitegrast Ophthalmic Solution Vehicle: Dosed twice a day for 8 weeks
|
Lifitegrast Ophthalmic Solution 5%
n=15 Participants
Lifitegrast 5% Ophthalmic Solution: Dosed twice a day for 8 weeks
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.27 years
STANDARD_DEVIATION 4.57 • n=5 Participants
|
27.20 years
STANDARD_DEVIATION 5.97 • n=7 Participants
|
26.73 years
STANDARD_DEVIATION 5.25 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
CLDEQ8 Total Score
|
21 units on a scale
n=5 Participants
|
22 units on a scale
n=7 Participants
|
21 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksMeasured 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).
Outcome measures
| Measure |
Lifitegrast Ophthalmic Solution Vehicle
n=15 Participants
Lifitegrast Ophthalmic Solution Vehicle: Dosed twice a day for 8 weeks
|
Lifitegrast Ophthalmic Solution 5%
n=15 Participants
Lifitegrast 5% Ophthalmic Solution: Dosed twice a day for 8 weeks
|
|---|---|---|
|
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
Interval -8.0 to -2.0
|
-5 units on a scale
Interval -8.0 to -2.0
|
SECONDARY outcome
Timeframe: 2 weeksMeasured 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).
Outcome measures
| Measure |
Lifitegrast Ophthalmic Solution Vehicle
n=15 Participants
Lifitegrast Ophthalmic Solution Vehicle: Dosed twice a day for 8 weeks
|
Lifitegrast Ophthalmic Solution 5%
n=15 Participants
Lifitegrast 5% Ophthalmic Solution: Dosed twice a day for 8 weeks
|
|---|---|---|
|
Change in Total Score on the CLDEQ- 8 From Baseline to 2 Weeks
|
-3.2 units on a scale
Standard Deviation 3.90
|
-3.93 units on a scale
Standard Deviation 4.96
|
SECONDARY outcome
Timeframe: 4 weeksMeasured 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).
Outcome measures
| Measure |
Lifitegrast Ophthalmic Solution Vehicle
n=15 Participants
Lifitegrast Ophthalmic Solution Vehicle: Dosed twice a day for 8 weeks
|
Lifitegrast Ophthalmic Solution 5%
n=15 Participants
Lifitegrast 5% Ophthalmic Solution: Dosed twice a day for 8 weeks
|
|---|---|---|
|
Change in Total Score on the CLDEQ- 8 From Baseline to 4 Weeks
|
-3.53 units on a scale
Standard Deviation 5.18
|
-5.6 units on a scale
Standard Deviation 3.96
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Lifitegrast Ophthalmic Solution Vehicle
n=15 Participants
Lifitegrast Ophthalmic Solution Vehicle: Dosed twice a day for 8 weeks
|
Lifitegrast Ophthalmic Solution 5%
n=13 Participants
Lifitegrast 5% Ophthalmic Solution: Dosed twice a day for 8 weeks
|
|---|---|---|
|
Change in Tear Osmolarity OD (Right Eye) From Baseline to Week 8
|
-1 mOsm/L (milliosmoles/liter)
Interval -14.0 to 2.0
|
-1 mOsm/L (milliosmoles/liter)
Interval -11.0 to 5.0
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Lifitegrast Ophthalmic Solution Vehicle
n=15 Participants
Lifitegrast Ophthalmic Solution Vehicle: Dosed twice a day for 8 weeks
|
Lifitegrast Ophthalmic Solution 5%
n=13 Participants
Lifitegrast 5% Ophthalmic Solution: Dosed twice a day for 8 weeks
|
|---|---|---|
|
Change in Tear Osmolarity OS (Left Eye) From Baseline to Week 8
|
6 mOsm/L
Interval -11.0 to 13.0
|
0 mOsm/L
Interval -12.0 to 6.0
|
SECONDARY outcome
Timeframe: 8 weeksForced choice questionnaire asking if the participant felt that their symptoms improved to the point that they would continue treatment outside of the study
Outcome measures
| Measure |
Lifitegrast Ophthalmic Solution Vehicle
n=15 Participants
Lifitegrast Ophthalmic Solution Vehicle: Dosed twice a day for 8 weeks
|
Lifitegrast Ophthalmic Solution 5%
n=15 Participants
Lifitegrast 5% Ophthalmic Solution: Dosed twice a day for 8 weeks
|
|---|---|---|
|
Forced Choice Questionnaire
Yes they would continue treatment
|
8 Participants
|
4 Participants
|
|
Forced Choice Questionnaire
No they would not continue treatment
|
7 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 8 weeksMeasured 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
Outcome measures
| Measure |
Lifitegrast Ophthalmic Solution Vehicle
n=15 Participants
Lifitegrast Ophthalmic Solution Vehicle: Dosed twice a day for 8 weeks
|
Lifitegrast Ophthalmic Solution 5%
n=15 Participants
Lifitegrast 5% Ophthalmic Solution: Dosed twice a day for 8 weeks
|
|---|---|---|
|
Change in Score for Each Question on the CLDEQ-8 From Baseline to Week 8
Question 1A Change
|
-1 units on a scale
Interval -2.0 to 0.0
|
-1 units on a scale
Interval -1.0 to 0.0
|
|
Change in Score for Each Question on the CLDEQ-8 From Baseline to Week 8
Question 1B Change
|
-1 units on a scale
Interval -2.0 to 0.0
|
-1 units on a scale
Interval -2.0 to -1.0
|
|
Change in Score for Each Question on the CLDEQ-8 From Baseline to Week 8
Question 2A Change
|
-1 units on a scale
Interval -1.0 to 0.0
|
-1 units on a scale
Interval -1.0 to 0.0
|
|
Change in Score for Each Question on the CLDEQ-8 From Baseline to Week 8
Question 2B Change
|
-1 units on a scale
Interval -1.0 to 0.0
|
-1 units on a scale
Interval -1.0 to 0.0
|
|
Change in Score for Each Question on the CLDEQ-8 From Baseline to Week 8
Question 3A Change
|
0 units on a scale
Interval -1.0 to 1.0
|
0 units on a scale
Interval -1.0 to 0.0
|
|
Change in Score for Each Question on the CLDEQ-8 From Baseline to Week 8
Question 3B Change
|
0 units on a scale
Interval -1.0 to 0.0
|
0 units on a scale
Interval -2.0 to 0.0
|
|
Change in Score for Each Question on the CLDEQ-8 From Baseline to Week 8
Question 4 Change
|
0 units on a scale
Interval -1.0 to 0.0
|
-1 units on a scale
Interval -1.0 to 0.0
|
|
Change in Score for Each Question on the CLDEQ-8 From Baseline to Week 8
Question 5 Change
|
-1 units on a scale
Interval -1.0 to 0.0
|
-1 units on a scale
Interval -2.0 to -1.0
|
Adverse Events
Lifitegrast Ophthalmic Solution Vehicle
Lifitegrast Ophthalmic Solution 5%
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lifitegrast Ophthalmic Solution Vehicle
n=15 participants at risk
Lifitegrast Ophthalmic Solution Vehicle: Dosed twice a day for 8 weeks
|
Lifitegrast Ophthalmic Solution 5%
n=15 participants at risk
Lifitegrast 5% Ophthalmic Solution: Dosed twice a day for 8 weeks
|
|---|---|---|
|
Eye disorders
Blurry Vision
|
0.00%
0/15 • During the 8 weeks of study participation
|
13.3%
2/15 • Number of events 2 • During the 8 weeks of study participation
|
|
Eye disorders
Ocular Burning
|
6.7%
1/15 • Number of events 1 • During the 8 weeks of study participation
|
20.0%
3/15 • Number of events 3 • During the 8 weeks of study participation
|
|
Infections and infestations
Common Cold
|
6.7%
1/15 • Number of events 1 • During the 8 weeks of study participation
|
13.3%
2/15 • Number of events 2 • During the 8 weeks of study participation
|
|
Eye disorders
Conjunctival Hyperemia
|
6.7%
1/15 • Number of events 2 • During the 8 weeks of study participation
|
6.7%
1/15 • Number of events 1 • During the 8 weeks of study participation
|
|
Infections and infestations
COVID-19
|
6.7%
1/15 • Number of events 1 • During the 8 weeks of study participation
|
0.00%
0/15 • During the 8 weeks of study participation
|
|
General disorders
Dysguesia
|
0.00%
0/15 • During the 8 weeks of study participation
|
46.7%
7/15 • Number of events 7 • During the 8 weeks of study participation
|
|
General disorders
Syncope
|
6.7%
1/15 • Number of events 1 • During the 8 weeks of study participation
|
0.00%
0/15 • During the 8 weeks of study participation
|
|
Infections and infestations
Influenza
|
0.00%
0/15 • During the 8 weeks of study participation
|
6.7%
1/15 • Number of events 1 • During the 8 weeks of study participation
|
|
Eye disorders
Ocular Mucous Discharge
|
0.00%
0/15 • During the 8 weeks of study participation
|
13.3%
2/15 • Number of events 2 • During the 8 weeks of study participation
|
|
Infections and infestations
Skin Infection
|
6.7%
1/15 • Number of events 1 • During the 8 weeks of study participation
|
0.00%
0/15 • During the 8 weeks of study participation
|
|
Infections and infestations
Sore Throat/ Tonsillitis
|
6.7%
1/15 • Number of events 1 • During the 8 weeks of study participation
|
6.7%
1/15 • Number of events 1 • During the 8 weeks of study participation
|
|
Infections and infestations
Stomach Virus
|
6.7%
1/15 • Number of events 1 • During the 8 weeks of study participation
|
0.00%
0/15 • During the 8 weeks of study participation
|
|
General disorders
Wisdom Tooth Removal
|
0.00%
0/15 • During the 8 weeks of study participation
|
6.7%
1/15 • Number of events 1 • During the 8 weeks of study participation
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place