ACTRN12621001737820
Completed
Phase 4
Changes in corneal epithelial irregularity following treatment with artificial tears in a symptomatic dry eye population
SW Sydney0 sites50 target enrollmentDecember 20, 2021
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Dry eye
- Sponsor
- SW Sydney
- Enrollment
- 50
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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;
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.
Outcomes
Primary Outcomes
Not specified
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