Immediate Effects of Lipid-Based and Non-Lipid Artificial Tears on Corneal Aberrations
NCT ID: NCT06784661
Last Updated: 2025-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
40 participants
INTERVENTIONAL
2025-02-01
2025-03-15
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Lipid-Based Artificial Tear Formulation
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.
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.
Non-Lipid Artificial Tear Formulation
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
35 Years
ALL
Yes
Sponsors
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Alcon Research
INDUSTRY
University of Seville
OTHER
Responsible Party
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José-María Sánchez-González
Optometry Doctor, PhD
Locations
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ISEC Lisboa
Lisbon, , Portugal
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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USeville_2025_01
Identifier Type: -
Identifier Source: org_study_id
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