Dry Eye
Conditions
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.
Interventions
DRUGLifitegrast
Lifitegrast ophthalmic solution 5%
Sponsors
MDbackline, LLC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Increase accuracy of preoperative biometry at predicting postoperative equivalent refractive error | 4 weeks | Increase accuracy of preoperative biometry at predicting postoperative equivalent refractive error after 4 weeks of lifitegrast ophthalmic solution (5%) BID. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare SPEED questionnaire scores before and after 4 weeks of lifitegrast treatment | 4 weeks | 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. |
| Determine the percentage of patients with low SPEED scores | 4 weeks | 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. |
Countries
United States
Outcome results
None listed