Dry Eye Clinical Trial
Official title:
Improvement in Markers of Tear Film Instability After Initiation of Lifitegrast 5% Ophthalmic Solution: A Prospective Interventional Study
Verified date | February 2021 |
Source | Weill Medical College of Cornell University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to assess the duration of time (in weeks) for improvement in objective dry eye markers for people who are placed on lifitegrast 0.5% (Xiidra®), an FDA-approved therapy for dry eyes.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Signs or symptoms of Dry Eye Disease - 18 years or older - Abnormal MMP9 (positive as read by 2 blinded investigators with both in agreement) and/or Abnormal tear osmolarity (greater than or equal to 308 or an inter-eye difference >=8 mOsm/mL) Exclusion Criteria: - Active eye infection. Patients with blepharitis may be enrolled. - Any eye drop that was instilled within 2 hours of the Baseline eye exam - Current contact lens wearer. Subjects who have not worn contact lenses 30 days prior to baseline and have no intention to wear CLs during the study duration may enroll. - History of ocular herpes simplex - Active episcleritis, scleritis, iritis or uveitis - Active keratitis secondary to any etiology other than dry eyes - History of refractive surgery (LASIK or PRK) or penetrating corneal transplant (PK) - Uses eye drops (ex. glaucoma or allergy drops) for indications other than dry eyes - Active allergic conjunctivitis - Current use of punctal plugs or anticipation of use during the study - Use of topical ophthalmic steroids within 14 days of the Baseline Visit or anticipated use during the study - Use of lifitegrast 5% or Restasis within 30 Days of the Baseline Visit. - Allergy to lifitegrast 5% |
Country | Name | City | State |
---|---|---|---|
United States | Weill Cornell Ophthalmology | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University | Novartis |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The change in proportion of subjects demonstrating improved tear film osmolarity | Improved tear film osmolarity will be defined as an osmolarity reading of less than or equal to 308 mOsm/L or an inter-eye difference osmolarity reading of less than or equal to 8 mOsm/L. | Baseline, Weeks 1, 2, 3 and 4 | |
Secondary | The proportion of subjects demonstrating normal Matrix Metallopeptidase 9 (MMP9). | Normal MMP9 is determined by 2 blinded investigators who each independently read the test result as negative and who are in agreement. | Week 4 | |
Secondary | The proportion of subjects demonstrating normal Tear Break-Up Time (TBUT). | Greater than 10 seconds is normal, 5 to 10 seconds is marginal, and less than 5 seconds is low. | Week 4 | |
Secondary | The proportion of subjects demonstrating normal corneal fluorescein staining. | Corneal staining will be assessed using the National Eye Institute Scale for corneal staining. | Week 4 | |
Secondary | The proportion of subjects demonstrating improvement in their symptoms as measured by the modified SANDE Questionnaire. | A modified SANDE Questionnaire uses a visual analogue scale at the Baseline Visit to measure the frequency and severity of subject's dry eyes symptoms. Subsequent visit Questionnaires will use a visual analogue scale to measure the change in symptoms compare to the results of the prior visit. | Week 4 |
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