CompletedPhase 4

Immediate Effects of Lipid-Based and Non-Lipid Artificial Tears on Corneal Aberrations

Portugal40 participantsStarted 2025-02-01

Plain-language summary

This study evaluates the immediate effects of two types of artificial tear formulations on corneal aberrations in a healthy population. The interventions include a lipid-based formulation containing mineral oil and hydroxypropyl guar, and a non-lipid formulation containing hydroxypropyl guar alone. Participants will receive a single instillation of each formulation in separate eyes, with measurements of corneal aberrations taken before and 15 minutes after instillation. The study aims to compare the optical changes induced by these formulations and assess their impact on the ocular surface quality.

Who can participate

Age range18 Years – 35 Years

SexALL

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Inclusion Criteria: Healthy individuals aged 18 to 35 years. No prior history of ocular surface disease, refractive surgery, or contact lens wear. Corrected visual acuity of 20/20 or better. Ability to provide informed consent. Willingness to comply with study procedures, including instillation of artificial tears and follow-up measurements. Exclusion Criteria: History of any ocular surgery or trauma within the past six months. Use of any systemic or topical medications that may affect ocular surface stability or tear film. Any active or chronic ocular infection, inflammation, or other pathology. Known hypersensitivity or allergy to any components of the artificial tears. Pregnancy or breastfeeding. Participation in another clinical trial within the last 30 days.

What they're measuring

Changes in Corneal Higher-Order Aberrations (HOAs)

Timeframe: Baseline to 15 minutes post-instillation

Trial details

NCT IDNCT06784661

SponsorUniversity of Seville

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-01