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 prospective, 6-month, double-masked, randomised, parallel group comparator trial aims to contribute sound scientific evidence to help address a current gap in the existing dry eye disease literature, especially with regard to: (1) The maximal benefit that can be achieved from twice daily periocular application of castor oil relative to baseline (2) The relative efficacy and patient reported experience of twice daily castor oil formulation application compared to twice daily application of saline (placebo control) (3) The temporal profile or clinical course of benefit arising from ongoing application, including the time taken to reach maximal benefit, based on clinically meaningful improvements in dry eye symptoms and signs. The overall aim is to assist practitioners in recognising the potential benefits of a natural castor oil-based formulation for the management of blepharitis, to be able to set realistic expectations regarding magnitude of effect according to presenting severity, and to provide sound evidence regarding efficacy and patient satisfaction relative to a placebo control.
Interventions
After training by clinical researchers, participants will be randomised to topically apply either approximately 0.2g of a proprietary cold pressed castor oil preparation or 0.2mL saline control to the external upper and lower eyelid skin surfaces close to the eyelash line.
Application will be to both the eyelids of both eyes using a dedicated 10ml vial fitted with a roller ball applicator, in which contents are obscured by opaqueness of the bottle and by bottle labelling, twice daily (morning
After training by clinical researchers, participants will be randomised to topically apply either approximately 0.2g of a proprietary cold pressed castor oil preparation or 0.2mL saline control to the external upper and lower eyelid skin surfaces close to the eyelash line. Application will be to both the eyelids of both eyes using a dedicated 10ml vial fitted with a roller ball applicator, in which contents are obscured by opaqueness of the bottle and by bottle labelling, twice daily (morning and night) for 6 months. Adherence to the intervention in the study will be monitored subjectively by participant-reporting via daily diary and objectively by weighing returned bottles and comparing the weight after 1 month of use to the weight on issue.
Sponsors
The University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
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 • Minimum of 6 months since onset of self-reported Dry Eye Disease (DED) symptoms • Normal lid architecture, and closure • Dry eye diagnosis according to the Tear Film and Ocular Surface Dry Eye Workshop II (TFOS DEWS II) diagnostic criteria (Symptoms: Dry Eye Questionnaire 5 (DEQ5( greater or equal to 6 or Ocular Surface Disease Index (OSDI) greater or equal to 13 and Signs: 1 positive finding on Non Invasive Break Up Time (NIBUT) (<10 s) / osmolarity (308mOsm/L or interocular difference of > 8mOsm/L) /staining (> 5 corneal spots, 9 conjunctival spots or Lid Wiper Epitheliopathy (LWE) of 2mm length and 25% lid margin width) • Evidence of blepharitis (lash crusting (>10 lashes), madarosis (>20% missing lashes), lipid layer grade greater or equal to 2, meibomian gland capping grade greater or equal to 1, and/or meibomian gland expressibility score of greater or equal to grade 2)
Exclusion criteria
• Abnormal eyelid architecture that prevents full eyelid closure during blinking • Inability or unwillingness to commit to 6-month trial • Unwillingness or inability to refrain from topical eye drop use, including artificial tear supplements, for at least 48 hours prior to baseline visit or within 24 hours of any subsequent study visit • Refusal to limit topical supplement use to ‘rescue use’ only • Refusal to be advised of incidental findings • Wear of contact lenses within 48 hours of study commencement or during the study • Warm compress therapy within 30 days of screening unless applied regularly and consistently throughout the course of the study and not within 48 hours of the screening visit or within 24 hours of subsequent clinical visits. • Lid debridement or therapeutic gland expression within 30 days of the screening visit or during the course of the study • Prior iLux, Lipiflow or IPL treatment within 6 months of study commencement • Punctal plugs, unless non-dissolvable (silicone plugs or cautery of < 3 months duration) • History of ocular surgery (such as refractive or cataract surgery) in either eye within 3 months of the screening 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, or deemed to be contraindicated for participation • A systemic condition or disease considered unstable or judged by the investigator to be incompatible with participation in the study (including but not limited to current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease) • Self-reported pregnancy or lactation. • 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 screening visit or during the trial • Current or planned use of medication known to cause ocular drying (including but not limited to antihistamines, tricyclic antidepressants, anxiolytics, antimuscarinics, beta-blocking agents, diuretics, phenothiazines, steroids) within 30 days of the screening visit • Use of oral medications not associated with ocular drying, unless stable dose for at least 30 days and continued at the same dose throughout the trial • Participation in any clinical trial with a new active substance or a new device within 30 days of the screening visit
Outcome results
None listed