None listed
Conditions
Brief summary
The research study aims to evaluate the effect of two different commercially available eye drops on the outermost layer (epithelium) of the cornea (clear, front surface of the eye), compared to saline, in subjects with dry eye. The corneal epithelium is more irregular in subjects with dry eye compared to non-dry eye populations. Therefore, this study will investigate whether the study eye drops improve corneal epithelial irregularity and how quickly this occurs following treatment.. Participants will be randomly allocated (like flipping a coin) to the eye drops to be used in this study four times daily. Assessments will be conducted 48 hours, 2 weeks and 4 weeks after the study eye drops are dispensed. Subjective comfort will also be measured before and at each follow-up visit using questionnaires. The primary timepoint is 2 weeks, but outcomes up to 4 weeks after starting treatment, including the 48 hour timepoint, will be analysed.
Interventions
Commercially available, over-the-counter eye drops:
1. Systane Hydration
2. Hylo-Forte
One drop to be instilled in each eye four times daily for 4 weeks.
Participants will be randomly allocated to one of the two study eye drops, or the control treatment (saline) in an equal 1:1:1 ratio, in this parallel group study.
The assigned study eye drops will be instilled in both eyes by participants.
Compliance to treatment will be determined via verbal confirmation at each follow-up visit.
Sponsors
UNSW Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Aged 18 years or older; • Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent; • Minimum of 6 months since onset of self-reported dry eye; • Ocular Surface Disease Index score (OSDI) of >23 or Oxford Corneal Staining score 2 or 3 in at least one eye at Screening (Visit 1); • Not wearing soft contact lenses for 1 month prior to the study and for the duration of the study; • Willing to use the study eye drops four times daily for the duration of the study; • Been on stable dry eye treatment for at least 60 days prior to the study and willing to refrain from using any other topical eye drops apart from the study eye drops for the duration of the trial; • Willing to refrain from using warm compress treatments for dry eye for the duration of the trial; • Willing to refrain from using any eye drops on the same day as the first study visit, and within 2 hours of each study visit; • All prescription medications have been used consistently for at least 3 months prior to the study, and no planned changes for the duration of the trial; • No significant changes to diet implemented within 3 months prior to the first visit; • No planned changes to diet and willing not to substantially alter their usual diet for the duration of the study, including use of any polyunsaturated fatty acid-containing dietary supplements (such as fish oil, evening primrose oil, linseed oil); • Willing to comply with the study visit schedule and adhere to instructions as directed by the Investigator.
Exclusion criteria
• Any active anterior segment disease; • Corneal abnormality or disorder that impacts normal spreading of the tear film (keratoconus, pterygia, scarring) or corneal integrity; • Patients who are currently using topical ocular medication or have used topical ocular medication within 12 weeks of the first visit; • Any known allergy to the study eye drops; • 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 corneal eye infection or any eye surgery; • Gas permeable contact lens wearer (including ortho-k) within 6 months of the first visit; • Pregnancy or breastfeeding.
Outcome results
None listed