Developing evidence-based guidance for the treatment of dry eye disease (DED) with artificial tear supplements

Not Applicable

Recruiting

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

• Registration Number: ACTRN12619000390189
• Lead Sponsor: The University of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-12
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

•Able and willing to comply with study instructions
•Minimum of 6 months since onset of self-reported DED
•Normal lid architecture, and eyelid closure
•Dry eye diagnosis according to the TFOS DEWS II diagnostic criteria (Symptoms: DEQ5 or OSDI and Signs: at least 1 positive finding on NIKBUT/osmolarity/staining).

Exclusion Criteria

•Non-normal lid architecture affecting lid closure/blink
•Inability or refusal to commit to 6-month trial
•Refusal or inability to refrain from topical eye drop use, including artificial tear supplements, for at least 48 hours prior to baseline visit
•Refusal to restrict topical eye drop use to only the study tear supplement
•Refusal to be advised of incidental findings
•Wear of contact lenses within 48 hours of study commencement or during the study
•Warm compress therapy, unless performed regularly, for a minimum of 30 days, and maintained at the same frequency throughout the course of the trial
•Punctal plugs, unless non-dissolvable (silicone plugs or cautery of at least 3 months duration)
•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 (less than 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
•Use of oral medications not associated with ocular drying, unless stable dose for at least 3 months and continued at the same dose throughout trial
•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