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| Name | Class |
|---|---|
| Turun Silmäexpertit Oy, Turku, Finland | UNKNOWN |
| The Finnish Funding Agency for Technology and Innovation | OTHER_GOV |
| Finnsusp Oy, Lieto, Finland | UNKNOWN |
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Dry eye is a common syndrome associated with symptoms of dryness, burning, itching and grittiness of eyes. The objective of this study is to investigate the effects of a moisturizing product in liquid formula on symptoms and signs of dry eye and on skin around the eyes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moisturizing Eye Product (product in development) | Experimental | Moisturizing eye product in liquid form (medical device product in development). Part 1 of the study: Administered to both eyes 4 times/day for 1 day. Part 2: to one eye 4 times/day for 9 days. Part 3: to one eye 4 times/day for 45 days. Parts 2 & 3: treatment eyes randomized. |
|
| Moisturizing Eye Product, Comparison | Active Comparator | Moisturizing eye product in liquid form (medical device CE-marked). Part 2 of the study: Administered to one eye 4 times/day for 9 days. Treatment eyes randomized. |
|
| No treatment | No Intervention | Part 3 of the study: other eye is a control eye with no treatment for 45 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moisturizing Eye Product in Liquid Formula | Device | Moisturizing Eye Product in Liquid Formula for dry eyes and skin around the eyes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in symptoms of dry eye: Ocular Surface Disease Index (OSDI), scores of dryness, burning and foreign body sensation of eyes | Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days | |
| Change in tear film osmolarity (mOsm/L) | Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days | |
| Change in tear film break-up time (s) | Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days | |
| Change in tear secretion, Schirmer test (mm/min) | Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days | |
| Change in signs of irritation of eyes, scoring by an eye specialist | Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days | |
| Change in transepidermal water loss from skin around the eyes (g/m2h) | Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in other symptoms of dry eye: soreness, grittiness, watery eyes, redness, blurring of eyes (daily symptom logbooks: scoring in scale from 0 to 3) | Part 2: change from baseline to 9 days; Part 3: change from baseline to 45 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Minna Sandberg-Lall, MD | Turun Silmäexpertit Oy, Turku, Finland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Turun Silmäexpertit Oy | Turku | Finland |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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