Effect of Systane hydration on ocular comfort and ocular surface damage among type 2 diabetics with dry eye disease and diabetic neuropathy

Phase 4

• Conditions: Dry eye disease; Diabetes; Diabetic neuropathy; Eye - Diseases / disorders of the eye; Metabolic and Endocrine - Diabetes; Neurological - Other neurological disorders

• Registration Number: ACTRN12620001346965
• Lead Sponsor: SW

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-14
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

For the first phase of the study, participants with type 2 diabetes will be recruited and examined for the signs and symptoms of dry eye disease. Participants will be at least 18 years of age.
To be included in the second phase of the study, participants will need to have neuropathy AND an OSDI score greater than or equal to 12, as well as one of the following: the presence of either corneal or conjunctival staining, a tear break-up time of <10 seconds, or osmolarity greater than or equal to 308 mOsm/L in either eye or interocular difference > 8mOsm/L. An approximately equal number of mild, moderate and severe dry eye participants will be recruited based on the OSDI scores (mild >12-17; moderate 18-35; severe 36-100). The group receiving Systane Hydration first and the group receiving saline first will be age-matched, with similar body mass index (BMI), duration of diabetes, neuropathy severity and gender distribution and will be recruited from the Diabetes Centre at the Prince of Wales Hospital, Sydney, Australia. We have shown that age can impact on both the signs and symptoms of dry eye disease as well as the presence of corneal nerves and dendritic cells. Therefore age will be carefully controlled between groups.

Exclusion Criteria

Patients will be excluded from the study if they have a history of other medical illnesses known to be associated with neuropathy. Exclusion criteria include malignant disease, connective tissue disease or infectious disease, neurotoxin exposure, deficiency of vitamin B12, family history of neuropathy or active diabetic foot ulcers. Patients will also be excluded from the study if they present with current eye infections, corneal abrasions, or a history of refractive surgery, eye surgery within 12 weeks immediately prior to study enrolment, contact lens wear, anterior segment trauma or are taking ocular medication category S3.

Study & Design

• Study Type: Interventional
• Study Design: Not specified