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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
| Bausch & Lomb Incorporated | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifitegrast Ophthalmic Solution Vehicle | Placebo Comparator |
| |
| Lifitegrast Ophthalmic Solution 5% | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifitegrast 5% Ophthalmic Solution | Drug | Dosed twice a day for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Subjects must read, understand and sign the Statement of Informed Consent
Subjects must be at least 18 years of age
Subjects must be habitual soft contact lens (CL) wearers, with a daily, weekly, bi- weekly or monthly replacement schedule
Habitual contact lenses must have a suitable fit as determined by the investigator
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
Subjects must be willing to discontinue the use of Artificial Tears (ATs) and rewetting drops for the duration of the study
Subjects must have a score of 12 or higher on the CLDEQ (Contact Lens Dry Eye Questionnaire-8) at baseline
Subjects must have at least 2 of the following signs of dry eye disease:
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.
Subjects currently wearing reusable contact lenses must be willing to use Clear Care solution for cleaning and disinfecting throughout the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Danielle Iacono, OD | State University of New York College of Optometry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State University of New York College of Optometry Clinical Vision Research Center | New York | New York | 10036 | United States |
2 subjects were enrolled in the study but not randomized due to screen failure
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| ID | Title | Description |
|---|---|---|
| FG000 | Lifitegrast Ophthalmic Solution Vehicle | Lifitegrast Ophthalmic Solution Vehicle: Dosed twice a day for 8 weeks |
| FG001 | Lifitegrast Ophthalmic Solution 5% | Lifitegrast 5% Ophthalmic Solution: Dosed twice a day for 8 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
2 subjects who were not randomized due to screenfailure not included
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| ID | Title | Description |
|---|---|---|
| BG000 | Lifitegrast Ophthalmic Solution Vehicle | Lifitegrast Ophthalmic Solution Vehicle: Dosed twice a day for 8 weeks |
| BG001 | Lifitegrast Ophthalmic Solution 5% | Lifitegrast 5% Ophthalmic Solution: Dosed twice a day for 8 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Median | Inter-Quartile Range | units on a scale | 8 weeks |
|
During the 8 weeks of study participation
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lifitegrast Ophthalmic Solution Vehicle | Lifitegrast Ophthalmic Solution Vehicle: Dosed twice a day for 8 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blurry Vision | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Danielle Iacono | SUNY College of Optometry | 2129385936 | diacono@sunyopt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 3, 2021 | Oct 16, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C575157 | lifitegrast |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
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| Lifitegrast Ophthalmic Solution Vehicle | Other | Dosed twice a day for 8 weeks |
|
| 2 weeks |
| 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). | 4 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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 | 8 weeks |
| 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 | 8 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| CLDEQ8 Total Score | 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 score (no symptoms) is 0. The maximum score (most symptomatic) is 37. The baseline measure reported is median total score at baseline. | Median | Inter-Quartile Range | units on a scale |
|
| OG001 | Lifitegrast Ophthalmic Solution 5% | Lifitegrast 5% Ophthalmic Solution: Dosed twice a day for 8 weeks |
|
|
|
| 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). | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
|
| 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). | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
|
|
|
|
| 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. | 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. | Posted | Median | Inter-Quartile Range | mOsm/L (milliosmoles/liter) | 8 weeks |
|
|
|
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| 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. | 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. | Posted | Median | Inter-Quartile Range | mOsm/L | 8 weeks |
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|
|
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| 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 | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
|
| 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 | Posted | Median | Inter-Quartile Range | units on a scale | 8 weeks |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 5 |
| 15 |
| EG001 | Lifitegrast Ophthalmic Solution 5% | Lifitegrast 5% Ophthalmic Solution: Dosed twice a day for 8 weeks | 0 | 15 | 0 | 15 | 12 | 15 |
| Ocular Burning | Eye disorders | Systematic Assessment |
|
| Common Cold | Infections and infestations | Non-systematic Assessment |
|
| Conjunctival Hyperemia | Eye disorders | Systematic Assessment |
|
| COVID-19 | Infections and infestations | Non-systematic Assessment |
|
| Dysguesia | General disorders | Non-systematic Assessment |
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| Syncope | General disorders | Non-systematic Assessment |
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| Influenza | Infections and infestations | Non-systematic Assessment |
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| Ocular Mucous Discharge | Eye disorders | Systematic Assessment |
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| Skin Infection | Infections and infestations | Non-systematic Assessment |
|
| Sore Throat/ Tonsillitis | Infections and infestations | Non-systematic Assessment |
|
| Stomach Virus | Infections and infestations | Non-systematic Assessment |
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| Wisdom Tooth Removal | General disorders | Non-systematic Assessment |
|
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| D020228 |
| Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| Question 2A Change |
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| Question 2B Change |
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| Question 3A Change |
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| Question 3B Change |
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| Question 4 Change |
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| Question 5 Change |
|
| 0.53 |
| Superiority |
| Question 2a change from baseline to week 8 in lifitegrast vs vehicle groups | Wilcoxon (Mann-Whitney) | 0.66 | Superiority |
| Question 2b change from baseline to week 8 in lifitegrast vs vehicle groups | Wilcoxon (Mann-Whitney) | 0.81 | Superiority |
| Question 3a change from baseline to week 8 in lifitegrast vs vehicle groups | Wilcoxon (Mann-Whitney) | >0.999 | Superiority |
| Question 3b change from baseline to week 8 in lifitegrast vs vehicle groups | Wilcoxon (Mann-Whitney) | 0.47 | Superiority |
| Question 4 change from baseline to week 8 in lifitegrast vs vehicle groups | Wilcoxon (Mann-Whitney) | 0.52 | Superiority |
| Question 5 change from baseline to week 8 in lifitegrast vs vehicle groups | Wilcoxon (Mann-Whitney) | 0.69 | Superiority |