Changes in corneal epithelial irregularity following treatment with artificial tears in a symptomatic dry eye populatio

Phase 4

Completed

• Conditions: Dry eye; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12621001737820
• Lead Sponsor: SW Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-20
• Study Completion: 2022-08-26
• Last Update Posted: 12 December 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in corneal epithelial irregularity factor (EIF). Epithelial thickness will be measured using the Optical Coherence Tomographer and the EIF calculated as previously described in the literature (Abou Shousha et. al. Eye (2020) 34:915-922).[The primary timepoint is 2 weeks after starting the treatment. <br>Follow-up visits are planned at 48 hours, 2 weeks and 4 weeks after starting treatment.]

Secondary Outcome Measures

Name	Time	Method
Ocular Surface Disease Index Score[Up to 4 weeks after starting treatment.<br>Follow-up visits are planned at 48 hours, 2 weeks and 4 weeks after starting treatment.];Fluorescein corneal staining will be used to evaluate the integrity of the corneal surface.[Up to 4 weeks after starting treatment.<br>Follow-up visits are planned at 48 hours, 2 weeks and 4 weeks after starting treatment.]