None listed
Conditions
Brief summary
The ability of artificial tear supplements, that are commercially available ‘over-the-counter’, to improve tear film stability and reduce symptoms of dry eye will be evaluated. Specifically the clinical course of artificial tear supplement effects, including how quickly improvements in signs and symptoms occur and the time taken to reach maximal treatment effect will be assessed. The outcomes relative to dry eye subtype, such as those deficient in tear volume or those who exhibit poor tear quality at baseline, will be evaluated.
Interventions
Brief name: artificial tear supplement instillation of Systane Ultra (SU) and Systane Complete (SC) (Alcon, Inc.)
Participants will be randomized to self administer 1-2 drops (20-40 microlitres) of either SU or SC topically, a minimum of four times daily in both eyes for a 6-month period. Drops can be instilled as often as needed (no maximum), as per the instructions provided by the manufacturers for this product. Compliance will be assessed by weighing bottles before and after use. Applicati
Brief name: artificial tear supplement instillation of Systane Ultra (SU) and Systane Complete (SC) (Alcon, Inc.) Participants will be randomized to self administer 1-2 drops (20-40 microlitres) of either SU or SC topically, a minimum of four times daily in both eyes for a 6-month period. Drops can be instilled as often as needed (no maximum), as per the instructions provided by the manufacturers for this product. Compliance will be assessed by weighing bottles before and after use. Application of 1- 2 drops increases the chance of application to the intended area. The eye can hold only 1 drop at any one time therefore any excess fluid in the eye will spill over or be expelled by blinking. Systane Ultra contains: Active ingredients: Polyethylene Glycol 400 0.4%Lubricant Propylene Glycol 0.3% Inactive ingredients: Aminomethylpropanol, boric acid, hydroxypropyl guar, POLYQUAD® (polyquaternium-1)0.001% preservative, potassium chloride, purified water, sodium chloride, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH. Systane Complete contains: Active ingredient: Propylene Glycol 0.6% Inactive ingredient: boric acid, dimyristoyl phosphatidylglycerol, edatate disodium, hydroxypropyl guar, mineral oil, polyoxl 40 stearate, POLYQUAD® (polyquaternium-1) 0.001% preservative, sorbitan tristearate, sorbitol and purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.
Sponsors
The University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed