Seborrheic BlepharitisPhase 4NCT04441528
Lid Wipes Versus Baby Shampoo in Patients With Seborrehic Blepharitis
A Phase 4 study testing Lid wipes containing terpinen-4-ol and sodium hyaluronate in people with Seborrheic Blepharitis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seborrheic Blepharitis
- What is being tested?
- Lid wipes containing terpinen-4-ol and sodium hyaluronate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2018to 1 Nov 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of seborrheic blepharitis
Who cannot join
- Patients with ophthalmological pathologies that may affect the tear film functions including ocular rosacea, contact lens use, history of any ocular surgery, or patients with systemic pathologies or those using systemic medications that may affect the tear film functions
- Patients younger than 18-year-old
- Patients who used any treatment for blepharitis within the 6 months prior to the examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Double-Blind Trial of Lid Wipes Containing Terpinen-4-ol and Sodium Hyaluronate Versus Baby Shampoo in Patients With Seborrheic Blepharitis
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.
Read the detailed description
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).
- Conditions
- Seborrheic Blepharitis
- Being tested
- Lid wipes containing terpinen-4-ol and sodium hyaluronate, Baby shampoo
- Keywords
- seborrheic blepharitis, terpinen-4-ol, baby shampoo, lid wipes, sodium hyaluronate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lid wipes containing terpinen-4-ol and sodium hyaluronateDrug
Lid wipes will be used in 24 patients for 8 weeks and will be discontinued in the following 4 weeks.
Baby shampooDrug
Baby will be used in 24 patients for 8 weeks and will be discontinued in the following 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Lid wipes containing terpinen-4-ol and sodium hyaluronate |
| 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. Receives: Drug: Baby shampoo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 0-4-8-12 weeks
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 0-4-8-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start1 Nov 2018
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seborrheic BlepharitisStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Koç University
- Responsible party
- Principal investigator, Ceyhun Arici, MD, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441528
- Sponsor's protocol ID
- IRB2021
- Status last verified
- Jun 2020
- First submitted
- 18 Jun 2020
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-Blind Trial of Lid Wipes Containing Terpinen-4-ol and Sodium Hyaluronate Versus Baby Shampoo in Patients With Seborrheic Blepharitis
- ClinicalTrials.gov ID
- NCT04441528
- Acronym / sponsor ID
- IRB2021
- Conditions
- Seborrheic Blepharitis
- Keywords
- seborrheic blepharitis, terpinen-4-ol, baby shampoo, lid wipes, sodium hyaluronate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Koç University
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 22 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lid wipes containing terpinen-4-ol and sodium hyaluronate | Experimental | Drug: Lid wipes containing terpinen-4-ol and sodium hyaluronateThe 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 | Drug: Baby shampooBaby shampoo will be applied on the eyelids twice a day for 8 weeks followed by a discontinuation period of 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of seborrheic blepharitis
Key exclusion criteria (3 listed)
- Patients with ophthalmological pathologies that may affect the tear film functions including ocular rosacea, contact lens use, history of any ocular surgery, or patients with systemic pathologies or those using systemic medications that may affect the tear film functions
- Patients younger than 18-year-old
- Patients who used any treatment for blepharitis within the 6 months prior to the examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lid wipes containing terpinen-4-ol and sodium hyaluronateLid wipes will be used in 24 patients for 8 weeks and will be discontinued in the following 4 weeks. | Drug | Lid wipes containing terpinen-4-ol and sodium hyaluronate |
| Baby shampooBaby will be used in 24 patients for 8 weeks and will be discontinued in the following 4 weeks. | Drug | Baby shampoo |
Primary outcome
Efficacy of the treatment assessed by the change in Blepharitis Symptom measure (BLISS) score
Time frame: 0-4-8-12 weeks
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)
6 secondary outcomes
Efficacy of the treatment assessed by the change in Demodex mite count by light microscopy
Time frame: 0-4-8-12 weeks
Efficacy of the treatment assessed by the change in the Schirmer test results
Time frame: 0-4-8-12 weeks
Efficacy of the treatment assessed by the change in the 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
Time frame: 0-4-8-12 weeks
Efficacy of the treatment assessed by the change in the 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
Time frame: 0-4-8-12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lid wipes containing terpinen-4-ol and sodium hyaluronate in people with Seborrheic Blepharitis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the treatment assessed by the change in Blepharitis Symptom measure (BLISS) score (time frame: 0-4-8-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2020.