A Phase 4 interventional study of Lid wipes containing terpinen-4-ol and sodium hyaluronate and Baby shampoo in Seborrheic Blepharitis, sponsored by Istanbul University - Cerrahpasa. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-22.
Sponsored by Istanbul University - Cerrahpasa · Phase 4, Interventional, and Treatment
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).
73 studies on the registry are indexed under Blepharitis; 9 are open to participants now.
This study's enrollment of 48 is below the median of 60 across 65 interventional studies indexed under Blepharitis.
Browse Blepharitis studies →Istanbul University - Cerrahpasa is the lead sponsor of 699 studies on the registry; 213 are open to participants now.
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Exclusion Criteria:
The lid wipes will be applied on the eyelids twice a day for 8 weeks followed by a discontinuation period of 4 weeks.
Drug: Lid wipes containing terpinen-4-ol and sodium hyaluronate
Baby shampoo will be applied on the eyelids twice a day for 8 weeks followed by a discontinuation period of 4 weeks.
Drug: Baby shampoo
Lid wipes will be used in 24 patients for 8 weeks and will be discontinued in the following 4 weeks.
Baby will be used in 24 patients for 8 weeks and will be discontinued in the following 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)
Time frame: 0-4-8-12 weeks
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.
Time frame: 0-4-8-12 weeks
Efficacy of the treatment assessed by the change in the Schirmer test results
Dry eye evaluation will be made with Schirmer test.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 0-4-8-12 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Nov 2018 to primary completion in Nov 2019, 12 months.
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This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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