Not Yet RecruitingPhase 2ACTRN12618000856213

Can castor oil improve tear film and ocular surface quality?

Evaluation of the ocular surface and tear film effects of topical castor oil application to the eyelids in participants with blepharitis


Sponsor

The University of Auckland

Enrollment

60 participants

Start Date

Jun 1, 2018

Study Type

Interventional

Conditions

Summary

Eyedrops containing castor oil can be used to relieve symptoms of dry eye disease. This study seeks to determine if the application of castor oil to the eyelids improves the eyelid margin health and the tear film quality. This is a prospective, investigator-masked, paired-eye trial where one eye of each participant with bilateral anterior blepharitis will be selected for castor oil application according to a computerised randomisation schedule created pre-recruitment. The fellow eye will remain untreated, as the control. Clinicians collecting data will be masked with respect to the eye that has been assigned castor oil application. Participants will be asked to refrain from applying castor oil on the day of assessment to minimise the risk of unmasking. Pre-treatment signs & symptoms will be measured using validated, non-invasive dry eye clinical tests. Following 4 weeks of twice daily application of castor oil to both upper and lower eyelids with a roller ball applicator, post-treatment signs and symptoms will be remeasured and compared to baseline. The battery of tests will take up to 45 minutes to perform at each visit and will include clinical tests and patient reported outcomes via symptom questionnaires.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria4

  • Aged over 18 years
  • Clinical signs and symptoms of anterior blepharitis
  • Symmetry in signs and symptoms of both eyes at baseline
  • Crusting of the eyelashes and/or signs of meibomian gland dysfunction

Exclusion Criteria5

  • Current topical use of eye drops other than occasional use of artificial tears
  • Current active infection
  • Abnormal eyelid architecture that prevents full eyelid closure during blinking
  • Use of systemic medications that are known to affect the lacrimal system (cause eye dryness)
  • Changed or planned change in systemic medication within 4 weeks of study commencement

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Interventions

After training by clinical researchers, participants will topically apply approximately 0.2g of 100% cold pressed castor oil to the external upper and lower eyelid skin surfaces close to the eyelash l

After training by clinical researchers, participants will topically apply approximately 0.2g of 100% cold pressed castor oil to the external upper and lower eyelid skin surfaces close to the eyelash line. Application will be to one eye only using a dedicated 10ml vial fitted with a roller ball applicator, twice daily (morning and night) for 4 weeks. Treatment compliance will be confirmed by text messaging on day 1 and weekly, with reminders not to apply castor oil on the day of assessment at week 4.


Locations(1)

Auckland, New Zealand

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