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

Phase 4

Not yet recruiting

• Conditions: Aberration, Corneal Wavefront
• Interventions: Drug: Lipid-Based Artificial Tear; Drug: Non-Lipid Artificial Tear

• Registration Number: NCT06784661
• Lead Sponsor: University of Seville

Brief 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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-14
• Study First Submitted QC: 2025-01-14
• Last Update Submitted: 2025-01-19
• Study First Posted: 2025-01-20
• Last Update Posted: 2025-01-22
• Study Start: 2025-02-01
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lipid-Based Artificial Tear Formulation	Lipid-Based Artificial Tear	Participants in this arm will receive a single drop of a lipid-based artificial tear formulation containing mineral oil and hydroxypropyl guar in each eye. The intervention is designed to enhance the lipid layer of the tear film and will be evaluated for its immediate effects on corneal aberrations 15 minutes post-instillation.
Non-Lipid Artificial Tear Formulation	Non-Lipid Artificial Tear	Participants in this arm will receive a single drop of a non-lipid artificial tear formulation containing hydroxypropyl guar in each eye. The intervention aims to improve aqueous layer stability and will be assessed for its immediate effects on corneal aberrations 15 minutes post-instillation.

Primary Outcome Measures

Name	Time	Method
Changes in Corneal Higher-Order Aberrations (HOAs)	Baseline to 15 minutes post-instillation	The primary outcome is the change in corneal higher-order aberrations (measured as RMS values) using wavefront aberrometry. Measurements will assess the optical impact of the lipid-based and non-lipid artificial tear formulations on the ocular surface.

Secondary Outcome Measures

Name	Time	Method
Stabilization of Tear Film	Baseline to 15 minutes post-instillation	This outcome evaluates the qualitative stabilization of the tear film post-instillation of the artificial tear formulations. Observations will include tear film uniformity and potential disruptions measured indirectly through aberrometry.

Trial Locations

Locations (1)

ISEC Lisboa; 🇵🇹 Lisboa, Portugal