None listed
Conditions
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.
Interventions
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 .
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).
Sponsors
Brien Holden Vision Institute Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
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
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.
Outcome results
None listed