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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifitegrast 5% | Patients will receive lifitegrast 0.5% eye drops twice daily 4 weeks prior to cataract surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifitegrast | Drug | Lifitegrast ophthalmic solution 5% |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harvard Eye Associates | Laguna Hills | California | 92653 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17102664 | Result | 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. | |
| 21450919 |
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There is not a plan to make individual patient data available.
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C575157 | lifitegrast |
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| 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 |
| Result |
| 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. |