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The purpose of this project is to determine the effectiveness of an eyewash osmoprotective lubricant comparing to castor oil containing and non-osmoprotective lubricants in different types of DTS and post refractive surgery patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| optive® eye drop | Active Comparator |
| |
| fresh tears ® eye drop | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optive ® | Other | instilation of 1 drop each eye 4 times per day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| patients satisfaction with osmoprotective lubricant on different types DTS. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Our purpose is to determine the differential effects of Optive® castor oil Endura ® on different types DTS. | 3 months | |
| Physician satisfaction with Optive® | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Our purpose is to determine the differential effects of Optive® vs. FreshTears ® on post refractive surgery patients. | 3 monthas | |
| change from baseline in Ocular Surface Disease Index (OSDI) | 3 moths | |
Inclusion Criteria:
Adult patients willing and able to comply with the protocol who are not planning changes in diet, topical or systemic drugs during the course of study.
DTS all the patients will be diagnosed for mild to moderate evaporative dry eye as defined by following criteria that will be given by Outcome measurements:
2.1. Break up time. 2.2. Lissamine green staining. 2.3. OSDI and Patient Symptomatology Questionnaire.
The patients, whose are going to be submitted for refractive surgery.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rossen M Hazarbassanov, MD | Department of Ophtahlmology, UNIFESP& EPM, Sao Paulo, SP, Brazil | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, UNIFESP&EPM | São Paulo | São Paulo | Brazil |
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| Label | URL |
|---|---|
| eye diseases | View source |
| FDA Resources on Drugs and Devices | View source |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Fresh Tears ® |
| Other |
instilation of eye drop 4 times a day (qid) |
|
| change from baseline in tear break up time (BUT) |
| 3 mothas |
| change from baseline in lissamine green staining | 3 months |
| change form baseline in impression cytology | 3 months |
| change from baseline in tear osmolarity | 3 months |