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To determine if the use of Xiidra® reduces ocular surface inflammation in preoperative and postoperative cataract patients.
Single-center, prospective, randomized, investigator-initiated study
250 cataract patients, aged 60 or older, will be tested for ocular surface inflammation with the InflammaDry® immunoassay
Patients with bilateral positive MMP-9 will be randomized into a group treated with Xiidra two weeks preoperatively and six weeks postoperatively or a group not treated with Xiidra
The investigator hypothesizes that treatment with Xiidra prior to routine cataract surgery will significantly improve the quality of keratometry readings and BCVA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifitegrast | Active Comparator | One drop of Lifitegrast Ophthalmic Solution 5% will be instilled into each eye twice daily (approximately 12 hours apart) using a single-use conainer. |
|
| Control | No Intervention | No treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifitegrast 5% Ophthalmic Solution | Drug | BID OU |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare the conversion rates of bilateral positive MMP-9 to negative in pre-cataract and post-cataract patients receiving treatment with Xiidra versus no Xiidra | Compare the conversion rates of bilateral positive MMP-9 to negative in pre-cataract and post-cataract patients receiving treatment with Xiidra versus no Xiidra | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank A Bucci, Jr., MD | Bucci Laser Vision | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bucci Laser Vision | Wilkes-Barre | Pennsylvania | 18702 | United States |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D007905 | Lens Diseases |
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| ID | Term |
|---|---|
| C575157 | lifitegrast |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
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| D020228 |
| Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |