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| Name | Class |
|---|---|
| Koç University | OTHER |
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The purpose of this study is to investigate the efficacy of lid wipes containing terpinen-4-ol and sodium hyaluronate (Hy-ter®) for the treatment of seborrheic blepharitis compared to baby shampoo.
After being informed about the study and potential risks, all patients giving written consent will have a complete ophthalmological examination to determine eligibilty for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double blind manner (participant and investigator) in a 1:1 ratio to lid wipes containing terpinen-4-ol and sodium hyaluronate (Hy-ter®) or baby shampoo (twice daily).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lid wipes containing terpinen-4-ol and sodium hyaluronate | Experimental | The lid wipes will be applied on the eyelids twice a day for 8 weeks followed by a discontinuation period of 4 weeks. |
|
| Baby shampoo | Active Comparator | Baby shampoo will be applied on the eyelids twice a day for 8 weeks followed by a discontinuation period of 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lid wipes containing terpinen-4-ol and sodium hyaluronate | Drug | Lid wipes will be used in 24 patients for 8 weeks and will be discontinued in the following 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of the treatment assessed by the change in Blepharitis Symptom measure (BLISS) score | BLISS score is calculated according to the answers given to the questionnaire. Higher BLISS scores is related to a worse outcome. (Range is between 0 and 39) | 0-4-8-12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of the treatment assessed by the change in Demodex mite count by light microscopy | The number of mites in the epilated 4 eyelashes will be counted under microscope. | 0-4-8-12 weeks |
| Efficacy of the treatment assessed by the change in the Schirmer test results |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University-Cerrahpasa | Istanbul | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Baby shampoo | Drug | Baby will be used in 24 patients for 8 weeks and will be discontinued in the following 4 weeks. |
|
Dry eye evaluation will be made with Schirmer test. |
| 0-4-8-12 weeks |
| Efficacy of the treatment assessed by the change in the tear breakup time | Dry eye evaluation will be made with tear breakup time. | 0-4-8-12 weeks |
| Efficacy of the treatment assessed by the change in the ocular surface disease index score | OSDI scores are calculated according to the responses to the questionnaire. Higher values are related to a worse outcome (range is between 0-100) | 0-4-8-12 weeks |
| Efficacy of the treatment assessed by the change in the non-invasive tear breakup time | Dry eye evaluation will be made with non-invasive tear breakup time. | 0-4-8-12 weeks |
| Efficacy of the treatment assessed by the change in the meibomian gland loss | Meibomian gland loss will be evaluated using anterior segment analysis system. | 0-4-8-12 weeks |