Status:
COMPLETED
The Effect Of Lifitegrast On Refractive Accuracy And Symptoms In Dry Eye Patients Undergoing Cataract Surgery
Lead Sponsor:
MDbackline, LLC
Conditions:
Dry Eye
Eligibility:
All Genders
Brief Summary
To determine if Xiidra® lifitegrast plays a role in the refractive accuracy when administered to patients preoperatively who are scheduled for cataract surgery and have a tear break up time (TBUT) ≤ 1...
Detailed Description
This will be a 4-week multicenter investigator-initiated study, in which a maximum of 200 subjects will be enrolled. As many as two thirds of patients undergoing cataract surgery have dry eye. Often ...
Eligibility Criteria
Inclusion
- Patients with planned cataract surgery
- 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
- Ocular surgery (e.g., intraocular, oculoplastic, corneal or refractive surgical procedure
- Clinically significant ocular trauma.
- Active ocular Herpes simplex or Herpes Zoster infection
- Ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis) 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).
- 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.
- Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis.
- 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).
- 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).
- Participation in another ophthalmic clinical trial involving a therapeutic drug or device within 30 days prior to enrollment date.
- Participation in this trial in the same patient's fellow eye
- Patients who are pregnant or breastfeeding or who may become pregnant during participation in the study.
Key Trial Info
Start Date :
December 20 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 29 2019
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT03866629
Start Date
December 20 2018
End Date
October 29 2019
Last Update
March 19 2020
Active Locations (1)
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1
Harvard Eye Associates
Laguna Hills, California, United States, 92653