None listed
Conditions
Brief summary
The topical application of eye drops is reported to have protective effects in low relative humidity environments. The single application of a lipomimetic formulation (Systane® Balance) demonstrated superior prophylactic efficacy against exposure to validated adverse environmental conditions induced by high air flow in subjects with mild-to-moderate dry eye compared to the non-lipid formulation, Systane® Ultra (SU). The newest addition to the Systane® family of drops, Systane® Complete (SC), offers the potential for similar or improved protection through increased HP Guar concentrations to confer additional moisture retention and increased surface lubricity from advanced lipid-delivering nanotechnology. Scientific literature to support the clinical benefits of SC is as yet unavailable. This project offers an opportunity to explore the benefits of SC application prior to exposure to an adverse environment. Knowledge that the tear film can be boosted so that it is better able to withstand adverse environments such as windy conditions or low relative humidity (e.g. air-conditioned environment / air travel) would be useful for clinicians managing patients affected by dry eye disease. The study aims to explore the ocular surface benefits in improving tear film quality and prophylactic potential of SC in resisting dryness-related clinical signs and symptoms following exposure to an adverse environment.
Interventions
Brief name: Instillation of Systane Ultra (SU) and Systane Complete (SC) (Alcon,Inc.) artificial tear supplements before exposure to a high air flow environment.
Participants will be randomized to have 1 drop (20 microlitres) of SU applied topically to either the right or left eye and a drop of SC (20 microlitres) applied to the partner eye. Tear quality will be assessed before and 10 minutes after drop instillation, and then again after exposure 20 minutes after drop instillation to an advers
Brief name: Instillation of Systane Ultra (SU) and Systane Complete (SC) (Alcon,Inc.) artificial tear supplements before exposure to a high air flow environment. Participants will be randomized to have 1 drop (20 microlitres) of SU applied topically to either the right or left eye and a drop of SC (20 microlitres) applied to the partner eye. Tear quality will be assessed before and 10 minutes after drop instillation, and then again after exposure 20 minutes after drop instillation to an adverse environment (moving air, at a speed of 3.2 metres per second, generated by a standing fan, placed 1 metre from the eyes, for 2.5 minutes). In a subsequent visit, at least 24 hours later, the drops are applied to the right and left eyes in the reverse order so that both the supplements are applied to both eyes over the course of the study. 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
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed