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Completed NCT07793344

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

Conditions: Dry Eye Disease

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 26
Sponsor: Regional Specialist Hospital in Wroclaw

Location: Regional Specialist Hospital in Wroclaw Wroclaw

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.

Eligibility Criteria

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07793344). StuddyBuddy aggregates publicly available trial information.