Ocular safety and efficacy of a skin cream – Lauricidin® – on signs and symptoms of meibomian gland dysfunction (MGD) and dry eye

Brien Holden Vision Institute Limited0 sites57 target enrollmentJanuary 12, 2016

Overview

No summary available.

Registry

who.int

Start Date

January 12, 2016

End Date

August 14, 2019

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

•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.

•\- 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;