The Effect Of Lifitegrast On Refractive Accuracy And Symptoms In Dry Eye Patients Undergoing Cataract Surgery

MDbackline

Status: Completed

Conditions: Dry Eye

Treatments: Drug: Lifitegrast

Study type: Observational

Funder types: Other

Identifiers

NCT03866629

IIR-USA-001246

Details and patient eligibility

About

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) ≤ 10 seconds and central corneal staining as defined by the Oxford scale

Full 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 this latter condition is under treated i.e., any dry eye treatment such as artificial tears, that is being pursued in not adequately controlling the visually significant ocular surface disruption, and patient still have corneal staining or a reduced tear break-up time (TBUT).

The investigators hypothesize that lifitegrast administered at least 4-week prior to pre-operative biometry measurements will improve both the quality of measurements used to choose an intraocular lens implant for surgery and the symptoms of patients with this combination of conditions. This finding would suggest that pre-treatment with lifitegrast can improve both the accuracy of surgery and patient comfort.

Enrollment: 103 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients with planned cataract surgery
2. Central or inferior corneal fluorescein staining defined by the Oxford Scale
3. Reduced tear break up time (TBUT) ≤ 10 seconds.
4. Able to comprehend and sign a statement of informed consent.
5. Willing and able to complete all required postoperative visits.

Exclusion criteria

1. Ocular surgery (e.g., intraocular, oculoplastic, corneal or refractive surgical procedure
2. Clinically significant ocular trauma.
3. Active ocular Herpes simplex or Herpes Zoster infection
4. Ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis) at the discretion of the investigator.
5. Ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungal infection or the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids including hordeolum/stye).
6. 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.
7. Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis.
8. Severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis)
9. Eyelid abnormalities that significantly affect the lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis).
10. 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).
11. Participation in another ophthalmic clinical trial involving a therapeutic drug or device within 30 days prior to enrollment date.
12. Participation in this trial in the same patient's fellow eye
13. Patients who are pregnant or breastfeeding or who may become pregnant during participation in the study.

Trial design

103 participants in 1 patient group

Lifitegrast 5%

Description:

Patients will receive lifitegrast 0.5% eye drops twice daily 4 weeks prior to cataract surgery.

Treatment:

Drug: Lifitegrast