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

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

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

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Drug: Lifitegrast

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.

• Study Type: Observational
• Enrollment (Actual): 103

Contacts and Locations

Study Locations

• United States
  • California
    • Laguna Hills, California, United States, 92653
      • Harvard Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lifitegrast 5%; Patients will receive lifitegrast 0.5% eye drops twice daily 4 weeks prior to cataract surgery.	Drug: Lifitegrast; Lifitegrast ophthalmic solution 5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increase accuracy of preoperative biometry at predicting postoperative equivalent refractive error	Increase accuracy of preoperative biometry at predicting postoperative equivalent refractive error after 4 weeks of lifitegrast ophthalmic solution (5%) BID.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare SPEED questionnaire scores before and after 4 weeks of lifitegrast treatment	To compare the difference in Standard Patient Evaluation of Eye Dryness Questionnaire (SPEED) scores before and after 4 weeks of therapy with lifitegrast BID among patients with signs of significant dry eye (decreased TBUT or corneal staining) with planned cataract surgery. The SPEED questionnaire gives a score from 0 to 28 that is the result of 8 items that assess frequency and severity of symptoms. Speed Score severity rating: 0-4 Mild, 5-7, Moderate, 8+ Severe.	4 weeks
Determine the percentage of patients with low SPEED scores	To determine the percentage of patients with low Standard Patient Evaluation of Eye Dryness Questionnaire (SPEED) scores (≤5 seconds) among patients with signs of significant dry eye (decreased TBUT or corneal staining) with planned cataract surgery. To determine whether this sub-group with asymptomatic dry eye experienced a mean improvement in accuracy of biometry readings after 4 weeks of Lifitegrast symptoms. The SPEED questionnaire gives a score from 0 to 28 that is the result of 8 items that assess frequency and severity of symptoms.	4 weeks

Collaborators and Investigators

• Sponsor: MDbackline, LLC

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2018
• Primary Completion (Actual): October 29, 2019
• Study Completion (Actual): October 29, 2019

Study Registration Dates

• First Submitted: December 20, 2018
• First Submitted That Met QC Criteria: March 5, 2019
• First Posted (Actual): March 7, 2019

Study Record Updates

• Last Update Posted (Actual): March 19, 2020
• Last Update Submitted That Met QC Criteria: March 18, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Cataract; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic Solutions; Lifitegrast
• Other Study ID Numbers: IIR-USA-001246

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make individual patient data available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No