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

NCT07793344 | Completed

• 2 other identifiers: WSS-KB02-2021-LIPONANOPOIR.04.01.01-00-0016/19-00
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dry Eye Disease

Keywords

Ocular Surface; Tear Film; Liposomal Nanocarrier; Ophthalmic Formulation

Outcome Measures

Primary Outcomes (1)

• Change in protocol-defined multidomain ocular-surface clinical assessment profile

  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.

  Baseline to end of the approximately 4-week use period

Secondary Outcomes (1)

• Change in optical tear-film parameters in the nested optical substudy

  Baseline to approximately 4 weeks

Other Outcomes (1)

• Diary-documented administration of the study formulation

  Throughout the 28-day study-use period

Study Arms (1)

Experimental liposomal nanocarrier

EXPERIMENTAL

Participants instilled the experimental ophthalmic liposomal nanocarrier bilaterally for four weeks.

Other: Experimental ophthalmic liposomal nanocarrier

Interventions

Experimental ophthalmic liposomal nanocarrier OTHER

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

Experimental liposomal nanocarrier

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Regional Specialist Hospital in Wroclaw: lead

Study Sites (1)

Regional Specialist Hospital in Wroclaw

Wroclaw, 51-124, Poland

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-group prospective before-and-after evaluation with baseline and approximately four-week follow-up assessments.

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: August 28, 2026
• Study Start: March 17, 2022
• Primary Completion: May 31, 2022
• Study Completion: June 30, 2022
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)