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

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03866629
• Other study ID #: IIR-USA-001246
• Status: Completed
• Start date: December 20, 2018
• Est. completion date: October 29, 2019

Study information

• Verified date: March 2020
• Source: MDbackline, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: October 29, 2019
• Est. primary completion date: October 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Lifitegrast
Lifitegrast ophthalmic solution 5%

Locations

Country	Name	City	State
United States	Harvard Eye Associates	Laguna Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
MDbackline, LLC

Country where clinical trial is conducted

United States, 

References & Publications (2)

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; Dysfunctiona — View 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 Op — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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