Clinical trial NCT03866629: The Effect Of Lifitegrast On Refractive Accuracy And Symptoms In Dry Eye Patients Undergoing Cataract Surgery
Official title: The Effect of Lifitegrast On Refractive Accuracy And Symptoms In Dry Eye Patients Undergoing Cataract Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye
Lead sponsor: MDbackline, LLC
Sponsor class: OTHER
First posted: 2019-03-07
Enrollment: 103
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This will be a multicenter US investigator initiated clinical trial, in which a maximum of 200 eyes will be treated with lifitegrast ophthalmic solution (5%) prior to planned cataract surgery.

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

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Increase accuracy of preoperative biometry at predicting postoperative equivalent refractive error
timeFrame: 4 weeks
Secondary outcomes:
measure: Compare SPEED questionnaire scores before and after 4 weeks of lifitegrast treatment
timeFrame: 4 weeks
measure: Determine the percentage of patients with low SPEED scores
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: Harvard Eye Associates
state: California
Study officials:
References:
citation: Behrens A, Doyle JJ, Stern L, Chuck RS, McDonnell PJ, Azar DT, Dua HS, Hom M, Karpecki PM, Laibson PR, Lemp MA, Meisler DM, Del Castillo JM, O'Brien TP, Pflugfelder SC, Rolando M, Schein OD, Seitz B, Tseng SC, van Setten G, Wilson SE, Yiu SC; Dysfunctional tear syndrome study group. Dysfunctional tear syndrome: a Delphi approach to treatment recommendations. Cornea. 2006 Sep;25(8):900-7. doi: 10.1097/01.ico.0000214802.40313.fa.
citation: Geerling G, Tauber J, Baudouin C, Goto E, Matsumoto Y, O'Brien T, Rolando M, Tsubota K, Nichols KK. The international workshop on meibomian gland dysfunction: report of the subcommittee on management and treatment of meibomian gland dysfunction. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):2050-64. doi: 10.1167/iovs.10-6997g. No abstract available.