None listed
Conditions
Brief summary
The clinical trial aims to learn about the short-term effect on the eye surface of a caffeine-based eye-drop in a number of concentrations. Caffeine eye-drops have been used in humans to study their effect on reducing the development of eye-conditions such as cataract and glaucoma. Caffeine may also be useful in potentially slowing the increase in short-sightedness as it has been shown to slow the increase in short-sightedness in a primate model of myopia. Participants will be randomly assigned an eye-drop and will instil one drop in each eye two times per day, Once in the morning and once before bed for a minimum of 5 days (maximum 7 days). Four types of eye drops will be trialled over the course of the study with two days in-between eye-drops where there will be no use of eye-drops.
Interventions
There are 3 test eye-drops and one placebo eye-drop. The test eye-drops are 1.4% caffeine , 2.0% caffeine and 1.4% caffeine combined with atropine 0.02% eye drops. Individuals will be randomly assigned to one type of eye-drop at a time and will eventually trial all four eye-drop types on study completion. Each eye-drop will be administered by the participant with one drop per eye in the morning and evening for a minimum of 5 days and a maximum of 7 days. There will be a two day washout perio
There are 3 test eye-drops and one placebo eye-drop. The test eye-drops are 1.4% caffeine , 2.0% caffeine and 1.4% caffeine combined with atropine 0.02% eye drops. Individuals will be randomly assigned to one type of eye-drop at a time and will eventually trial all four eye-drop types on study completion. Each eye-drop will be administered by the participant with one drop per eye in the morning and evening for a minimum of 5 days and a maximum of 7 days. There will be a two day washout period between each eye-drop type. The unused volume of the eye-drop will be returned and will be measured by the investigator to determine adherence to the intervention.
Sponsors
Brien Holden Vision Insitute
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
• Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent. • Be at least 18 years old, male or female. • Willing to instil each of the test eye drops daily for 5 days and follow the clinical trial visit schedule as directed by the Investigator. • Have ocular health findings considered to be “normal”.
Exclusion criteria
• Any pre-existing ocular irritation, injury or condition, including infection or disease. • Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants. • Use of or a need for concurrent category S3 and above ocular medication at enrolment and/or during the clinical trial. • Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant’s ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and/or during the clinical trial. • Eye surgery within 12 weeks immediately prior to enrolment for this trial. • Previous corneal refractive surgery. • Contraindications to caffeine such as high blood pressure, heart conditions and ADHD • Known allergy or intolerance to ingredients to caffeine. Contact lens wearer • Pregnancy and breastfeeding.* • Currently enrolled in another clinical trial. The Investigator may, at his/her discretion, exclude anyone who they believe may not be able to fulfil the clinical trial requirements or it is believed to be in the participant’s best interests. *Formal testing of pregnancy is not required. A participant’s verbal report is sufficient.
Outcome results
None listed