Exploring the impact of castor oil application on the eye's surface quality

Not Applicable

• Conditions: Anterior blepharitis; Dry eye disease; Meibomian gland dysfunction; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12623000012673
• Lead Sponsor: The University of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-09
• Last Update Posted: 16 January 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified