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

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.

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.