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NCT Number: NCT07793344

Four-Week Ocular-Surface Evaluation of an Experimental Ophthalmic Liposomal Nanocarrier in Dry Eye Disease

This prospective, single-group research medical experiment evaluated the ocular-surface response to repeated bilateral use of an experimental ophthalmic liposomal nanocarrier in adults with dry eye disease. Participants used one drop in each eye three times daily (morning, midday, and evening) for four weeks. Clinical assessments were performed at baseline and follow-up and included ocular-surface staining, tear-film stability, tear-volume measures, symptoms, and contextual ophthalmic measures. A nested optical assessment evaluated tear-film surface regularity and non-invasive tear-film parameters.

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Regional Specialist Hospital in Wroclaw

Wroclaw, 51-124, Poland

About this study

The study was conducted at the Regional Specialist Hospital in Wroclaw within project POIR.04.01.01-00-0016/19 as a research medical experiment under Polish law and was not classified as a medicinal-product clinical trial under the applicable national regulatory framework. The Bioethics Committee at the Regional Specialist Hospital in Wroclaw approved the research programme (KB/02/2021; 31 March 2021), and participants provided written informed consent.

Twenty-six participants were recruited. Twenty-one completed the approximately four-week clinical follow-up. One clinical completer was excluded from the nested optical analysis because excessive ocular movement prevented reliable interferometric signal acquisition, leaving 20 participants in the optical substudy.

The original exploratory research programme did not designate a single confirmatory efficacy endpoint. The protocol-defined assessment framework was multidomain and included visual acuity, slit-lamp examination, fluorescein tear break-up time, Schirmer I testing without topical anaesthesia, OCT tear-meniscus assessment, LIPCOF assessment, corneal fluorescein staining, conjunctival lissamine-green staining, central corneal thickness, intraocular pressure, posterior-segment assessment, Ocular Surface Disease Index, and optical tear-film measurements.

This ClinicalTrials.gov record was created retrospectively in 2026 to improve transparency and support scientific publication. Retrospective registration does not imply prospective registration and does not alter the original legal classification of the study in Poland.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 years or older with dry eye disease diagnosed by an ophthalmologist.
  • Written informed consent.
  • Ability to attend baseline and follow-up assessments and use the study formulation for approximately four weeks.

Exclusion criteria

  • Pregnancy
  • Breastfeeding
  • Ocular diseases or conditions considered by the examining ophthalmologist likely to interfere with study assessments or confound the study outcomes.

Treatment and study plan

Experimental ophthalmic liposomal nanocarrier

Other

One drop was instilled into each eye three times daily (morning, midday, and evening) for four weeks.

Primary outcomes

  1. Change in protocol-defined multidomain ocular-surface clinical assessment profile

    Time frame: Baseline to end of the approximately 4-week use period

    The exploratory protocol assessed ocular-surface and tear-film response using a predefined examination panel rather than a single confirmatory efficacy endpoint. The panel included corneal fluorescein staining, conjunctival lissamine-green staining, fluorescein tear break-up time, Schirmer I testing without topical anaesthesia, OCT-derived tear-meniscus height, Ocular Surface Disease Index, intraocular pressure, central corneal thickness, LIPCOF, visual acuity, slit-lamp examination, and posterior-segment assessment. The record intentionally does not retrospectively designate one of these measures as the sole primary efficacy endpoint.

Secondary outcomes

  1. Change in optical tear-film parameters in the nested optical substudy

    Time frame: Baseline to approximately 4 weeks

    The nested optical substudy assessed tear-film surface regularity using lateral shearing interferometry (M2_LSI and interblink slope a_LSI) and non-invasive tear-film parameters using an Ocular Surface Analyser, including tear-meniscus height, non-invasive break-up time, and lipid-layer thickness.

Other outcomes

  1. Diary-documented administration of the study formulation

    Time frame: Throughout the 28-day study-use period

    Participants recorded morning, midday, and evening administration separately for the right and left eye in a study diary. The protocol template therefore contained 84 scheduled bilateral administration events per participant over 28 days.

Sponsors and collaborators

Lead sponsor

Regional Specialist Hospital in Wroclaw

Other

Registry information

Official study title

A Prospective Single-Group Research Medical Experiment Evaluating Four-Week Ocular-Surface and Tear-Film Response to an Experimental Ophthalmic Liposomal Nanocarrier in Adults With Dry Eye Disease

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 28, 2026
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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