Dry Eye
Conditions
Brief summary
In patients with dry eye, defined as corneal staining and a reduced tear breakup time, lifitegrast will improve higher order aberrations, ocular scatter index, corneal staining, and TBUT as soon as 1 week after initiating treatment.
Detailed description
This is a multicenter, prospective, open label, self-controlled, single group study of the efficacy of Lifitegrast 5% in improving higher order aberrations, ocular scatter index, and best corrected visual acuity in patients with dry eye. All patients will receive lifitegrast 5% for 4 weeks and will be evaluated at baseline (before treatment) and at 7, 14, and 28 days
Interventions
Open label, self-controlled, single group study of the efficacy of Lifitegrast 5% in improving higher order aberrations, ocular scatter index, and best corrected visual acuity in patients with dry eye. All patients will receive lifitegrast 5% for 4 weeks and will be evaluated at baseline (before treatment) and at 7, 14, and 28 days.
Sponsors
Research Insight LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a multicenter, prospective, open label, self-controlled, single group study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Central or inferior corneal fluorescein staining defined by the Oxford Scale * Reduced tear break up time (TBUT) ≤ 10 seconds. * Able to comprehend and sign a statement of informed consent. * Willing and able to complete all required postoperative visits.
Exclusion criteria
* Ocular surgery (e.g., intraocular, oculoplastic, corneal or refractive surgical procedure performed in the study eye within the last 3 months or at any time that in the investigator's clinical judgment if it would interfere with the outcome measures of this study. * Clinically significant ocular trauma. * Active ocular Herpes simplex or Herpes Zoster infection * Ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis) that is active, at the discretion of the investigator. * Ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungal infection or the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids including hordeolum/stye), at the discretion of the investigator. * Active, systemic or local disease condition that causes clinically significant ocular surface irritation such that it could interfere with the questions in the survey and examination findings, in the opinion of the investigator. * Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis that would interfere with study findings, in the opinion of the investigator. * Severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis) * Eyelid abnormalities that significantly affect the lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis) that would interfere with study findings, in the opinion of the investigator. * Ocular surface abnormality that may compromise the corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, map dot fingerprint dystrophy, or the effect of any other ophthalmic medication that might in the opinion of the investigator compromise the ocular surface integrity). * Patients who are under age 18, pregnant or breastfeeding, or who may become pregnant during participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in corneal higher order aberrations | After 7, 14, and 28 days of treatment. | Change in corneal higher order aberrations after 7, 14, and 28 days of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in OSI after 7, 14, and 28 days of treatment. | After 7, 14, and 28 days of treatment. | Change in OSI after 7, 14, and 28 days of treatment. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in best corrected visual acuity after 7, 14, and 28 days of treatment. | After 7, 14, and 28 days of treatment. | Change in best corrected visual acuity after 7, 14, and 28 days of treatment. |
Countries
United States
Outcome results
None listed