None listed
Conditions
Brief summary
Blepharitis is considered an entry point into the vicious circle of dry eye disease, a self-perpetuating cycle of instability, hyperosmolarity, inflammation and ocular surface damage, and its pathophysiology can be represented as an inner vicious circle which promotes tear film instability and feeds into the dry eye disease vicious circle. This double-masked, randomised, controlled, paired-eye study investigates the mechanisms of action that 100% castor oil can exert on the tear film, compared to placebo control. These effects will be investigated through the use of non-invasive assessments of the tear film, over the course of 6 hours post application to the external eyelids.
Interventions
A single application of approximately 0.2g of 100% cold-pressed castor oil will be applied by a trained investigator to the external surface of the upper and lower eyelids of one eye, (according to the randomisation schedule) close to the lash line from an opaque 10ml bottle with roller ball applicator. Tear film and ocular surface characteristics will be evaluated at baseline and at 15 minutes, 2 hours, 4 hours and 6 hours after application.
Sponsors
The University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Age greater or equal to 18 years, able and willing to comply with study instructions • Normal lid architecture, and closure • Evidence of a thin lipid layer thickness <70 nm as measured with the LipiView OR tear film lipid layer grade < 4.
Exclusion criteria
• Abnormal eyelid architecture that prevents full eyelid closure during blinking • Inability or unwillingness to commit to attending all study visits. • Unwillingness or inability to refrain from topical eye drop use, including artificial tear supplements, for at least 24 hours prior to baseline visit and during the study duration • Refusal to be advised of incidental findings • Wear of contact lenses within 24 hours of study commencement or during the study • History of ocular surgery (such as refractive or cataract surgery) in either eye within 3 months of the study visit • History or presence of any ocular disorder or condition in either eye that would likely interfere with the interpretation of the study results or patient safety. This includes but is not limited to significantly reduced visual acuity (>20/200), significant corneal or conjunctival scarring, pterygium or nodular pinguecula; current ocular infection or inflammation unrelated to dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; ocular herpetic infection • Use of topical medications that might interfere with the study outcomes • Active or uncontrolled severe systemic allergy, chronic seasonal allergies, rhinitis or sinusitis requiring treatment (with antihistamines, decongestants, oral or aerosol steroids) at the time of the study visit • Participation in any clinical trial with a new active substance or a new device within 30 days of the study visit
Outcome results
None listed