Clinical Evaluation of Lifitegrast Ophthalmic Solution 5.0% in Dry Eye Disease Using In Vivo Confocal Microscopy
ConditionDry Eye
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorToyos Clinic
About this trial
This is a single center, open label trial to evaluate Lifitegrast Ophthalmic Solution 5.0% in Dry Eye Disease using In Vivo Confocal Microscopy (IVCM
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Subject can read, understand and sign an informed consent letter. 2. Provision of signed and dated informed consent form and HIPAA authorization. 3. Stated willingness to comply with all study procedures and availability for the duration of the study 4. Male or female at least 18 years of age at the time of enrollment 5. Minimum corneal staining of ≥2 or greater according to the NEI grading scale in the lower corneal subregion.
Disqualifiers
1. Have a known hypersensitivity or contraindication to the product or their components.
Trial design
Design model
Single group
Treatments tested in this trial
Lifitegrast Ophthalmic Solution 5.0% (Xiidra)
Drug30 subjects with DED will receive lifitegrast ophthalmic solution 5.0% (Xiidra)
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: DED subjects treated with lifitegrast ophthalmic solution 5.0% (Xiidra)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in immune cell density in subjects with dry eye disease treated with lifitegrast
Change from baseline (Day 0) immune cell density, as measured by in vivo confocoal microscopy (IVCM), in subjects with dry eye disease treated with Xiidra (Lifitegrast Opthalmic Solution 5.0%), at Day 84.
Time frame
84 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: