Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Koç University | OTHER |
Not provided
Not provided
Not provided
Not provided
The aim of the study was to compare the efficacy of lid swabs containing tea tree oil (TTO) and chamomile oil and baby shampoo (BS) in the treatment of seborrheic blepharitis.
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 using block randomization to lid wipes containing tea tree oil (TTO) and chamomile oil or baby shampoo (twice daily).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Swabs containing tea tree oil and chamomile oil | Experimental | The swabs 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 |
|---|---|---|---|---|
| Swabs containing tea tree oil and chamomile oil | Drug | Swabs will be used in 26 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) | Change from Baseline at 4 weeks |
| 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) | Change from Baseline at 8 weeks |
| 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) | Change from Baseline at 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's test results |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University-Cerrahpasa | Istanbul | Turkey (Türkiye) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000713170 | Chamomile extract |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baby shampoo | Drug | Baby shampoo will be used in 23 patients for 8 weeks and will be discontinued in the following 4 weeks. |
|
Dry eye evaluation will be made with Schirmer's 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 |