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In patients with dry eye, defined as corneal staining and a reduced tear breakup time, lifitegrast will improve higher order aberrations, ocular scatter index, corneal staining, and TBUT as soon as 1 week after initiating treatment.
This is a multicenter, prospective, open label, self-controlled, single group study of the efficacy of Lifitegrast 5% in improving higher order aberrations, ocular scatter index, and best corrected visual acuity in patients with dry eye. All patients will receive lifitegrast 5% for 4 weeks and will be evaluated at baseline (before treatment) and at 7, 14, and 28 days
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single /arm | Experimental | All patients will receive lifitegrast 5% for 4 weeks and will be evaluated at baseline (before treatment) and at 7, 14, and 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifitegrast 5% Ophthalmic Solution | Drug | Open label, self-controlled, single group study of the efficacy of Lifitegrast 5% in improving higher order aberrations, ocular scatter index, and best corrected visual acuity in patients with dry eye. All patients will receive lifitegrast 5% for 4 weeks and will be evaluated at baseline (before treatment) and at 7, 14, and 28 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in corneal higher order aberrations | Change in corneal higher order aberrations after 7, 14, and 28 days of treatment. | After 7, 14, and 28 days of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in OSI after 7, 14, and 28 days of treatment. | Change in OSI after 7, 14, and 28 days of treatment. | After 7, 14, and 28 days of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in best corrected visual acuity after 7, 14, and 28 days of treatment. | Change in best corrected visual acuity after 7, 14, and 28 days of treatment. | After 7, 14, and 28 days of treatment. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Hovanesian, MD | Research Insight LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harvard Eye Associates | Laguna Hills | California | 92653 | United States | ||
| Bowden Eye & Associates |
The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with, the Sponsor, and such that confidential or proprietary information is not disclosed,
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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 |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
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This is a multicenter, prospective, open label, self-controlled, single group study
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|
| Jacksonville |
| Florida |
| 32256 |
| United States |
| Cleveland Eye Clinic | Brecksville | Ohio | 44141 | United States |
| D020228 |
| Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |