Exploring the prophylactic benefits of artificial tear supplements in an adverse environment

Not Applicable

Recruiting

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

• Registration Number: ACTRN12619000361101
• Lead Sponsor: The University of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-06
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

•Normal lid architecture, and closure
•Dry eye diagnosis according to the TFOS DEWS II diagnostic criteria (Symptoms: DEQ-5 or OSDI and Signs: at least 1 positive finding on NIKBUT/osmolarity/staining).

Exclusion Criteria

•Non-normal lid architecture affecting lid closure/blink
•Artificial tear supplement use < 48 hours prior to study
•Marked bilateral asymmetry in tear film or ocular surface status
•Wear of contact lenses within 48 hours of study commencement or during the study
•Punctal plugs (unless permanent)
•History of ocular surgery (such as refractive or cataract surgery) in either eye within 3 months of the screening visit
•History or presence of any ocular disorder or condition in either eye that would likely interfere with the interpretation of the study results or patient safety. This includes but is not limited to significantly reduced visual acuity (below 20/200), significant corneal or conjunctival scarring, pterygium or nodular pinguecula; current ocular infection or inflammation unrelated to dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; ocular herpetic infection.
•Use of topical medications that might interfere with the study outcomes, or deemed to be contraindicated for participation
•A systemic condition or disease considered unstable or judged by the investigator to be incompatible with participation in the study (including but not limited to current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction)
•Self-reported pregnancy or lactation
•Active or uncontrolled severe systemic allergy, chronic seasonal allergies, rhinitis or sinusitis requiring treatment (with antihistamines, decongestants, oral or aerosol steroids) at the time of screening
•Use of medication known to cause ocular drying (including but not limited to antihistamines, tricyclic antidepressants, anxiolytics, antimuscarinics, beta-blocking agents, diuretics, phenothiazines, steroids) within 30 days of the screening visit
•Participation in any clinical trial with a new active substance or a new device within 30 days of the screening visit

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
on-invasive tear film stability (NIKBUT) measured objectively by the Oculus Keratograph 5M[Baseline<br>10 minutes after drop instillation<br>Within 5 minutes of adverse environment exposure (primary endpoint)];Lipid layer grade evaluated by a masked observer from interferometric video images captured on the Ocular Keratograph 5M[Baseline<br>10 minutes after drop instillation<br>Within 5 minutes of adverse environment exposure (primary endpoint)]

Secondary Outcome Measures

Name	Time	Method
Symptom severity evaluated on a visual analogue scale[Baseline <br>10 minutes after drop instillation<br>Within 5 minutes of adverse environment exposure ];Tear Meniscus Height (TMH) quantified using the digital callipers of the Oculus Keratograph 5M[Baseline <br>10 minutes after drop instillation<br>Within 5 minutes of adverse environment exposure ];Bulbar hyperaemia quantified objectively by the Oculus Keratograph 5M[Baseline <br>10 minutes after drop instillation<br>Within 5 minutes of adverse environment exposure ];Lid Wiper Epitheliopathy (LWE)[At screening<br>Following adverse environment exposure ]