The effect of Systane Complete versus saline on tear film properties in a symptomatic dry eye population
UNSW Sydney
20 participants
Apr 24, 2019
Interventional
Conditions
Summary
This study aims to compare tear film properties including lipid layer thickness, tear osmolarity, tear evaporation rate and noninvasive tear breakup time up to 2 hours after instillation of Systane Complete (test eye drop) versus unpreserved unit dose saline (control), and after 4 weeks of daily use. Participants will be randomly assigned to receive either the test or control eye drop at the first visit. Tear film measurements including the thickness of the oily layer (lipid), stability (noninvasive tear break-up time and tear evaporation rate) and osmolarity (saltiness), and tear collection will be conducted at 1 hour and 2 hours post-eye drop instillation. Participants will be dispensed with this eye drop to be used four times a day until the 4 week follow-up visit. At the 4 week follow-up visit, measurements will be conducted again and the eye drops will be collected. Participants will undergo a 4 week washout period and then be crossed over to receive the alternate eye drop where the same procedures will be repeated as for the first eye drop. Participants will be dispensed with this second eye drop to be used four times a day until the 4 week follow-up visit. At the 4 week follow-up visit, measurements will be conducted again and the eye drops will be collected.
Eligibility
Inclusion Criteria8
- Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent;
- Adults aged 18 years and over with symptoms of dry eye;
- Ocular Surface Disease Index score of greater than 12 at Screening (Visit 1);
- Average lipid layer thickness less than or equal to 75nm in at least one eye at Screening;
- Not wearing contact lenses for 1 month prior to the study and for the duration of the study;
- Willing to use the study eye drops and refrain from using any other eye drops for the duration of the study;
- Willing to refrain from using the study eye drops within 4 hours prior to each study visit;
- Willing to comply with the study visit schedule and adhere to instructions as directed by the Investigator.
Exclusion Criteria17
- Any active anterior segment disease excluding blepharitis;
- Use of any of the following medications (including steroids) up to 12 weeks prior to start of the study or during the course of the study:
- Ocular medication, category S3 and above;
- Any systemic or topical medications that will affect ocular physiology e.g. anti-acne medications such as Roaccutane and corticosteroid or immunosuppressant medications such as Hydrocortisone, Prednisolone and antihistamine medications such as Claritine.
- Use of any polyunsaturated fatty acid-containing dietary supplements (such as fish oil, evening primrose oil, linseed oil) for less than 12 weeks prior to the start of the study;
- Planned changes to intake of polyunsaturated fatty acid-containing dietary supplements and/or diet (including typical intake of fish) for the duration of the study;
- Use of any at-home eyelid warming treatments for less than 12 weeks prior to the start of the study, or planned changes to routine usage over the course of the study;
- Use of any of the following dry eye treatments up to 6 months prior to the start of the study or during the course of the study:
- o Intense Pulsed Light (IPL) therapy;
- o Blephasteam;
- o LipiFlow Thermal Pulsation treatment;
- o Punctal plugs.
- Any systemic disease that may affect ocular health e.g. Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis and systemic lupus erythematosus;
- History of eye surgery within 6 months prior to enrolment in the study;
- Epilepsy or history of migraines exacerbated by flashing, strobe-like lights;
- Any known allergy to the ingredients in Systane Complete;
- Pregnancy or breastfeeding.
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Interventions
Participants will be randomized to receive either the test Systane Complete (HP-Guar and mineral oil) lubricant eye drops, one drop (approx 40uL) to be instilled in each eye four times daily for 4 weeks, or the control eye drop unit dose saline (0.9% sodium chloride), one drop (approx 40uL) to be instilled in each eye four times daily for 4 weeks. Participants will undergo a 4 week washout period before being crossed over to the alternate eye drop. Adherence to treatment will be assessed by asking participants to return unused eye drop bottles and by questioning participants as to the average number of doses taken per day at the 4 week follow-up visit.
Locations(1)
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ACTRN12619000275167