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Trial registered on ANZCTR


Registration number
ACTRN12616000011482
Ethics application status
Approved
Date submitted
16/12/2015
Date registered
12/01/2016
Date last updated
9/09/2019
Date data sharing statement initially provided
9/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Ocular safety and efficacy of a skin cream - Lauricidin®
Scientific title
Ocular safety and efficacy of a skin cream – Lauricidin® – on signs and symptoms of meibomian gland dysfunction (MGD) and dry eye
Secondary ID [1] 288169 0
none
Universal Trial Number (UTN)
U1111-1177-7514
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dry eye 297074 0
Condition category
Condition code
Alternative and Complementary Medicine 297310 297310 0 0
Other alternative and complementary medicine
Eye 297320 297320 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The investigational test cream is "Lauricidin" (Epi-shield) and the control cream "Petroleum jelly" will be used in both safety and efficacy phases.
In the safety phase, randomised contralateral double masking was employed. Therefore, either the test or control cream was randomly applied once only to the skin surrounding the eyelid area of participant's right eye (Day 1) or left eye (Day 2) at the baseline visit, by a clinic team member who was not involved in any further clinical assessment .
In the efficacy phase, randomised parallel study design will be employed. Therefore, one group of participants will receive the test cream and the other group will receive the control cream randomly and they will apply the creams on both eyes . In this phase, participants will be instructed to apply the cream to the skin surrounding the eyelid area, twice a day for 6 weeks. Participants will be asked at each visit how thy have been applying the cream and the frequency at which they have been applying the cream. Participants will be monitored after 1 week, 3 weeks and 6 weeks after the baseline visit at the Clinical Research and Trials Centre, Brien Holden Vision Institute, UNSW.
Lauricidin Registered Trademark - Main ingredients: (glycerol monolaurate) 1%, Propylene glycol monocaprylat 1%, Lactic Acid 2%. Other ingredients: Petrolatum, Lanolin, Beeswax, C12-15 alkyl benzoate, cetyl alcohol).
Intervention code [1] 293473 0
Treatment: Other
Comparator / control treatment
The control cream is Petroleum jelly, comprising 100% white petrolatum (USP).
The control cream will be used both in the safety and efficacy phases,
Control group
Placebo

Outcomes
Primary outcome [1] 296880 0
Safety phase: change in eye redness from baseline post the topical application of cream will be assessed through the use of a slit lamp under diffuse illumination using ×10 to ×16 magnification. Clinical grades of eye redness will be recorded on a scale of 1 to 4 in steps of 0.5.
Timepoint [1] 296880 0
Baseline, 3 hrs after application, 6 hrs after application
Primary outcome [2] 304800 0
Safety phase: Change in corneal staining from baseline post the topical application of cream. Following the careful addition of sodium fluorescein (1 mg, Fluorets; Chauvin Pharmaceuticals Ltd., UK), the cornea will be observed with cobalt blue illumination using a Wratten 12 filter in front of the slit-lamp biomicroscope under ×10 to ×16 magnification. Corneal staining type will be graded for the cornea as a whole using a 0 to 4 scale 0.5 steps, while extent and depth of staining will be graded in 1 steps.
Timepoint [2] 304800 0
Baseline, 3 hrs after application, 6 hrs after application
Primary outcome [3] 304801 0
Efficacy phase: Change in dry eye symptoms score measured using Ocular Surface Disease Index (OSDI) questionnaire
Timepoint [3] 304801 0
Baseline, 1 week, 3 weeks, 6 weeks, 9 weeks
Secondary outcome [1] 319598 0
Safety phase: change in ocular symptoms from baseline post the topical application of cream, Secondary outcome was assessed by subjective rating on a numerical ocular discomfort scale (1-10) with 1 being most severe discomfort score and 10 being the highest comfort score. A worsening in ocular comfort score from baseline by more than 2 points was considered 'unsafe'.
Timepoint [1] 319598 0
Baseline, 3 hrs after application, 6 hrs after application
Secondary outcome [2] 343228 0
Efficacy phase: Change in fluorescein tear break-up-time (TBUT) as assessed with a slitlamp, sodium fluorescein and a stopwatch.
Timepoint [2] 343228 0
Baseline, 1 week, 3 weeks, 6 weeks, 9 weeks
Secondary outcome [3] 343229 0
A swab of the inferior lid margin using a sterile disposable q-tip. The swab sample will then immediately be stored in a sterile vial for later analysis. Lid swabs from individuals will be cultured, and the bacteria will be isolated and identified by gram-staining. Isolated bacteria will then be grown in liquid media, and the supernatant will be extracted and used to quantify the lipase levels through colorimetric assay.
Timepoint [3] 343229 0
Baseline, 1 week, 3 weeks, 6 weeks, 9 weeks

Eligibility
Key inclusion criteria
Safety phase: 1. Age of 18 years or above
2. Willing and able to sign a statement of informed consent
3. Willing to comply with the use of the investigational product and clinical trial visit schedule
4. Be willing to not wear contact lenses and / or use any eye drops for at least 2 days before and during the clinical trial.
5. Normal ocular findings without ocular pathology.

Efficacy phase:
1. Age of 18 years or above
2. Willing and able to sign a statement of informed consent
3. Willing to comply with the use of the investigational product and clinical trial visit schedule
4. Be willing to not wear contact lenses and / or use any eye drops for at least 2 days before and during the clinical trial.
5. At least one expressible meibomian gland in each eye
6. Dry eye symptoms score >12 on the Ocular Surface Disease Index (OSDI) scale
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Ocular pathology (Safety phase) other than dry eye/MGD (efficacy phase)
- Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, androgen deficiency and auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome, and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants.
- Concurrent punctal occlusion;
- Use of or a need for concurrent category S4 and above ocular medication at enrolment and/or during the clinical trial;
- Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant’s ocular health / physiology either in an adverse or beneficial manner at enrolment and/or during the clinical trial e.g. hormone replacement therapy or anti-androgen therapy;
- Eye surgery within 12 weeks immediately prior to enrolment for this trial.
- Previous corneal refractive surgery;
- Known allergy or intolerance to ingredients in any of the diagnostic products used during the clinical trial;
- Currently enrolled in another clinical trial;
- Current use of antibiotics;
- Pregnancy*.
The Investigator may, at his / her discretion, exclude anyone who he /she believes may not be able to fulfil the clinical trial requirements or it is believed to be in the participant’s best interests.
*Formal testing of pregnancy is not required. A participant’s verbal report is sufficient.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Safety phase study design: double masked, randomised, cross-over
Efficacy phase study design:double masked, randomised, parallel groups
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Safety phase: There will be about ten subjects in this phase. One eye of participants will be included for assessing the safety of the test and the other for the control cream in randomly manner.
Efficacy phase: a sample size of approximately 27 (+ 3) participants in each treatment group and a total sample of 54 (+6) participants will have at least 80% power at the 5% level of significance to detect the difference in the OSDI score from baseline to the end of the trial. Presuming there is a change in the dry eye category, every 10-point score on the OSDI scale changes the dry eye classification i.e. normal (<12.5), mild (13-22), moderate (23-32) and severe (33-100).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/10/2017
Actual
24/11/2017
Date of last participant enrolment
Anticipated
31/12/2020
Actual
12/06/2019
Date of last data collection
Anticipated
12/03/2021
Actual
14/08/2019
Sample size
Target
64
Accrual to date
Final
57
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 12466 0
2052 - Unsw Sydney

Funding & Sponsors
Funding source category [1] 292570 0
Charities/Societies/Foundations
Name [1] 292570 0
Brien Holden Vision Institute Limited
Country [1] 292570 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Brien Holden Vision Institute Limited
Address
Level 5, North Wing, RMB,
Gate 14, Barker Street,
University of New South Wales
SYDNEY NSW 2052
Country
Australia
Secondary sponsor category [1] 291295 0
None
Name [1] 291295 0
Address [1] 291295 0
Country [1] 291295 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294053 0
Bellberry Human Research Ethics Limited
Ethics committee address [1] 294053 0
129 Glen Osmond Road Eastwood South Australia 5063
Ethics committee country [1] 294053 0
Australia
Date submitted for ethics approval [1] 294053 0
23/06/2017
Approval date [1] 294053 0
20/10/2017
Ethics approval number [1] 294053 0
HREC REFERENCE #: 2017-06-471

Summary
Brief summary
Lauricidin is an over-the-counter wellness agent, the active ingredient of which is glycerol monolaurate (GML), a naturally occurring inhibitor of production of a bacterial enzyme (a lipase) which breaks down lipids (fats). GML is found in coconut, milk and other foods and is classed by the FDA as Generally Regarded as Safe (GRAS). Lauricidin is sold as a skin cream containing 1% glycerol monolaurate.
The purpose of this study is to determine the ocular safety (as measured by ocular redness, ocular staining and discomfort) of lauricidin moisturising cream in a normal population when applied around the eyelids, and the efficacy of the cream when used by dry eye disease participants for the treatment of dry eye. Efficacy will be determined using a number of clinical measures comprising Ocular Surface Disease index (OSDI) score, tear break up time and collection of bacteria from the eyelid using lid swabs.
Our hypotheses are that there will be no difference between lauricidin moisturising cream and petrolatum for eye redness, corneal staining and ocular symptoms during the safety phase and OSDI score, tear break up time and lid swabs during the efficacy phase.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62246 0
Ms Jennie Diec
Address 62246 0
Brien Holden Vision Institute Limited Level 5, North Wing, Rupert Myers Building Gate 14, Barker Street, UNSW NSW 2052
Country 62246 0
Australia
Phone 62246 0
+61293857537
Fax 62246 0
Email 62246 0
[email protected]
Contact person for public queries
Name 62247 0
Judith Flanagan
Address 62247 0
Level 3, North Wing,
RMB,
Gate 14, Barker Street,
University of New South Wales
SYDNEY NSW 2052
Country 62247 0
Australia
Phone 62247 0
+61293586166
Fax 62247 0
Email 62247 0
[email protected]
Contact person for scientific queries
Name 62248 0
Judith Flanagan
Address 62248 0
Level 3, North Wing,
RMB,
Gate 14, Barker Street,
University of New South Wales
SYDNEY NSW 2052
Country 62248 0
Australia
Phone 62248 0
+61293586166
Fax 62248 0
Email 62248 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not planned at present


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.