None listed
Conditions
Brief summary
It is important while trying to understand the effect of vitamins on the ocular surface and their association with dry eye disease, to try first to characterize the most effective chemical forms of vitamins, utilizing the proper methodologies and supplements with randomized controlled clinical studies. This PhD aims to explore the role of vitamin B12 oral consumption on corneal health and dry eye disease. These findings may in the future guide the development of novel treatment strategies for dry eye disease management.
Interventions
Oral vitamin B12 supplement:
-Mecobalamin 1000 microgram, once daily.
-3 months administration.
-Compliance will be monitored by counting the dispensed and returned capsules and bottles of capsules, as well as by questioning the participants at each visit. For remote compliance control participants will be asked to use the redcap platform.
Sponsors
University of New South Wales Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Be able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent. • No previous vitamin B12 commercial supplements in the last three months • Currently have been diagnosed with dry eye disease. • Be at least 18 years old • Be willing to comply with the consuming supplement product and clinical trial visit schedule.
Exclusion criteria
• Currently taking vitamin B12 commercial supplements. Participants will be advised not to change their diet for the duration of the study. • Eye surgery within 12 weeks immediately prior to enrolment for this trial • Previous corneal refractive surgery • Active corneal infection or any active ocular disease such as iritis, corneal oedema or corneal dystrophies, including anterior membrane dystrophy. • Any current ocular injury • Be currently enrolled in another clinical trial or have participated in a clinical trial within the previous 2 weeks. • Pregnant or lactating
Outcome results
None listed