NCT06188260

Efficacy of a New Nanoemulsion Artificial Tear Targeting Dry Eye Disease

Efficacy of a New Nanoemulsion Artificial Tear in Dry Eye Disease Management

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: The Hong Kong Polytechnic University · Academic / Other
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective cohort study to compare subjective changes in symptoms using the Ocular Surface Disease Index (OSDI) questionnaire, following the recommended dosage of the new nanoemulsion eye drops (Systane Complete)in mild to moderate dry eye patients, and to investigate objective ocular surface changes using modern clinical instruments during the study period.

Detailed description

This study, lasting for 3 months in total, is to investigate the changes in both subjective reports (OSDI score) and objective measurements (Non-invasive Tear Break Time (NITBUT) and other clinical signs such as corneal staining) after the use of this nanoemulsion eye drops (Systane Complete). Subjects are required to use the eyedrop qid for 3 months, and come back for follow-up at 2-week and 3-month visits. Other secondary measurements such as Meibography and lipid layer thickness, will also be investigated.

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
DRUG	Systane COMPLETE Lubricant Eye Drops	Active Ingredients: Propylene Glycol 0.6% Purpose: Lubricant

Timeline

• Start date: 2024-01-16
• Primary completion: 2024-11-04
• Completion: 2024-11-04
• First posted: 2024-01-03
• Last updated: 2024-12-02

Locations

1 site across 1 country: Hong Kong