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

NCT06784661 | Completed Phase 4

• 1 other identifier: USeville_2025_01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Aberration, Corneal Wavefront

Keywords

Corneal aberrations; Aberrations; Wavefront

Outcome Measures

Primary Outcomes (1)

• Changes in Corneal Higher-Order Aberrations (HOAs)

  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.

  Baseline to 15 minutes post-instillation

Secondary Outcomes (1)

• Stabilization of Tear Film

  Baseline to 15 minutes post-instillation

Study Arms (2)

Lipid-Based Artificial Tear Formulation

EXPERIMENTAL

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.

Drug: Lipid-Based Artificial Tear

Non-Lipid Artificial Tear Formulation

EXPERIMENTAL

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.

Drug: Non-Lipid Artificial Tear

Interventions

Lipid-Based Artificial Tear DRUG

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.

Lipid-Based Artificial Tear Formulation

Non-Lipid Artificial Tear DRUG

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.

Non-Lipid Artificial Tear Formulation

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Seville: lead
• Alcon Research: collaborator

Study Sites (1)

ISEC Lisboa

Lisbon, Portugal

Location

Related Publications (8)

• Yildirim Y, Ozsaygili C, Kucuk B. The short term effect of trehalose and different doses of sodium hyaluronate on anterior corneal aberrations in dry eye patients. Cutan Ocul Toxicol. 2021 Mar;40(1):14-20. doi: 10.1080/15569527.2020.1861001. Epub 2020 Dec 21.

  PMID: 33342322 BACKGROUND

• Lee H, Kim SM, Choi S, Seo KY, Kim EK, Kim TI. Effect of diquafosol three per cent ophthalmic solution on tear film and corneal aberrations after cataract surgery. Clin Exp Optom. 2017 Nov;100(6):590-594. doi: 10.1111/cxo.12521. Epub 2017 Feb 21.

  PMID: 28222481 BACKGROUND

• Mihaltz K, Faschinger EM, Vecsei-Marlovits PV. Effects of Lipid- Versus Sodium Hyaluronate-Containing Eye Drops on Optical Quality and Ocular Surface Parameters as a Function of the Meibomian Gland Dropout Rate. Cornea. 2018 Jul;37(7):886-892. doi: 10.1097/ICO.0000000000001523.

  PMID: 29377842 BACKGROUND

• Lekhanont K, Chuckpaiwong V, Vongthongsri A, Sangiampornpanit T. Effects of sodium hyaluronate on wavefront aberrations in dry eye patients. Optom Vis Sci. 2014 Jan;91(1):39-46. doi: 10.1097/OPX.0000000000000101.

  PMID: 24366433 BACKGROUND

• Habbe KJ, Frings A, Saad A, Geerling G. The influence of a mineral oil cationic nanoemulsion or perfluorohexyloctane on the tear film lipid layer and higher order aberrations. PLoS One. 2023 Jan 18;18(1):e0279977. doi: 10.1371/journal.pone.0279977. eCollection 2023.

  PMID: 36652431 BACKGROUND

• Saad A, Frings A. Influence of perfluorohexyloctane (Evotears(R)) on higher order aberrations. Int Ophthalmol. 2023 Dec;43(12):5025-5030. doi: 10.1007/s10792-023-02905-w. Epub 2023 Oct 21.

  PMID: 37864619 BACKGROUND

• Carpena-Torres C, Pastrana C, Rodriguez-Pomar C, Serramito M, Batres L, Carracedo G. Changes in visual quality with soft contact lenses after the instillation of hyaluronic acid eye drops. Cont Lens Anterior Eye. 2021 Dec;44(6):101471. doi: 10.1016/j.clae.2021.101471. Epub 2021 May 26.

  PMID: 34049809 BACKGROUND

• Sanchez-Gonzalez JM, Sanchez-Gonzalez MC, De-Hita-Cantalejo C, Nascimento H, Martinez-Perez C. Immediate Impact of Artificial Tear Composition on Optical Aberrations: A Comparative Study of Lipid and Non-Lipid Hydroxypropyl Guar Formulations. Ophthalmol Ther. 2025 Sep;14(9):2165-2178. doi: 10.1007/s40123-025-01205-z. Epub 2025 Jul 17.

  PMID: 40676409 DERIVED

MeSH Terms

Conditions

Corneal Wavefront Aberration

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Refractive Errors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, investigators, and outcomes assessors will not know which formulation is being administered. Identical containers and consistent procedures will ensure masking.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Optometry Doctor, PhD

Model Details: This parallel design allows for comparison of the effects of each formulation across two distinct groups. Each participant will receive a single application of their assigned formulation, and the effects will be measured uniformly at specific time points.

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 20, 2025
• Study Start: February 1, 2025
• Primary Completion: March 1, 2025
• Study Completion: March 15, 2025
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)