NCT06784661

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

Immediate Effects of Lipid-Based Artificial Tears (Mineral Oil and Hydroxypropyl Guar) and Non-Lipid Artificial Tears (Hydroxypropyl Guar) on Corneal Aberrations in Healthy Individuals

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Seville · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study explores the immediate effects of two types of artificial tear formulations on corneal aberrations in healthy individuals. The primary aim is to evaluate how a lipid-based formulation containing mineral oil and hydroxypropyl guar and a non-lipid formulation containing hydroxypropyl guar alone influence optical quality shortly after instillation. The results of this research will contribute to a better understanding of how these formulations interact with the ocular surface to enhance or alter corneal optical properties. The study will involve healthy participants aged 18 to 35 years, with no prior history of ocular surface disease, refractive surgery, or contact lens use. All participants will undergo a baseline assessment of corneal aberrations before any intervention. Each individual will then receive a single drop of the lipid-based formulation in one eye and the non-lipid formulation in the other eye. This approach allows for direct comparison between the two interventions within the same participant. Measurements of corneal aberrations will be taken 15 minutes after instillation to capture the immediate effects of each formulation on optical quality. The study is designed as a randomized, participant-masked clinical trial to ensure unbiased results. By measuring higher-order aberrations (HOAs) with wavefront aberrometry, the research will assess how these artificial tears affect the ocular surface's optical properties. This will provide valuable insights into their potential to stabilize the tear film and enhance visual performance. The trial follows ethical guidelines and has been approved by the appropriate Institutional Review Board. This research is important for advancing knowledge about artificial tear formulations and their role in managing ocular surface conditions. Although both formulations are commonly used in clinical practice, their specific effects on corneal aberrations immediately after application have not been thoroughly studied in a healthy population. The findings from this study will help inform healthcare providers and patients about the optical benefits and limitations of these widely used artificial tear formulations.

Conditions

• Aberration, Corneal Wavefront

Interventions

Type	Name	Description
DRUG	Lipid-Based Artificial Tear	This intervention consists of a lipid-based artificial tear formulation containing mineral oil and hydroxypropyl guar. It is designed to enhance the tear film's lipid layer and improve ocular surface stability. Participants in this group will receive a single drop in each eye, and corneal aberrations will be measured at baseline and 15 minutes after instillation.
DRUG	Non-Lipid Artificial Tear	This intervention consists of a non-lipid artificial tear formulation containing hydroxypropyl guar. It is intended to stabilize the aqueous layer of the tear film and maintain optical quality. Participants in this group will receive a single drop in each eye, and corneal aberrations will be measured at baseline and 15 minutes after instillation.

Timeline

• Start date: 2025-02-01
• Primary completion: 2025-03-01
• Completion: 2025-03-15
• First posted: 2025-01-20
• Last updated: 2025-01-22

Locations

1 site across 1 country: Portugal