The behaviour of and change to immune cells in the cornea when anti-inflammatory and immunosuppressant eye drops are topically applied into the eye of healthy individuals.

Not Applicable

Recruiting

• Conditions: autoimmune eye disorders; Eye - Normal eye development and function; Inflammatory and Immune System - Normal development and function of the immune system

• Registration Number: ACTRN12621000520831
• Lead Sponsor: Queensland University of Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-04
• Last Update Posted: 14 November 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Participants must satisfy the following conditions prior to inclusion in the study:
A)Aged at least 18 years
B)Good ocular health
C)Willing and able to comply with protocol (e.g. attend study visit)
D)Existing wearers should discontinue lens wear for at least 24 hours prior to examination.
E)Participants without dry eye will be included.
F)Former contact lens wearers will be included

Exclusion Criteria

Any of the following will render a participant ineligible for inclusion:
A)Current pregnancy, breastfeeding or traying to become pregnant
B)History of ocular trauma or surgery such as LASIK or PRK
C)Current or long-term use of topical ocular medication
D)Ocular disease or systemic disease that may affect the cornea or conjunctiva (epithelial defects, ulcers and corneal epithelial or basement membrane dystrophies).
E)Use of orthokeratology contact lenses within the past 3 months
G)Use of soft contact lenses in either eye within 1 month of the study or rigid gas permeable contact lenses within 3 months of the study
H)Dry eye disease (defined as defined as a 5-Item dry eye questionnaire (DEQ-5) score equal to 7.
AND failing at least one of the objective dry eye tests Non-Invasive Break-Up Time with less than or equal to 10s, or Corneal Fluorescein Staining with greater than or equal to 5 corneal spots.
(Note: both eyes will be assessed, and the worst eye will contribute toward the dry eye diagnosis)
H) Allergy to fluorometholone, lifitegrast or any of the excipients of the study drugs

Study & Design

• Study Type: Interventional
• Study Design: Not specified