Ocular safety and efficacy of a skin cream - Lauricidin®

Phase 1

Completed

• Conditions: dry eye; Alternative and Complementary Medicine - Other alternative and complementary medicine; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12616000011482
• Lead Sponsor: Brien Holden Vision Institute Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-12
• Study Completion: 2019-08-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 57

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified