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OpenTrials
Completed

NCT Number: NCT06188260

Efficacy of a New Nanoemulsion Artificial Tear Targeting Dry Eye Disease

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.

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Thomas LAM

Hong Kong, 999077

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 20-50 years old
  • Best corrected distance visual acuity ≥ 6/9
  • Mild to moderate OSDI score 13-32
  • Any one of the objective test positive (NITBUT/Corneal fluorescein staining/Tear osmolarity)

Exclusion criteria

  • Any active ocular infections
  • Inflammations or anomalies in the eyelid
  • Uncontrolled, newly diagnosed systemic diseases or with modified long-term medications within 6 months that are known to affect tear profile.
  • Pregnancy and breastfeeding
  • Contact lens wearers are required to stop contact lenses wear for at least 1 week before the evaluation.
  • Subjects who are using artificial tears or other eyedrops will be excluded.
  • Subjects who are taking systemic drugs that may cause dry eye, e.g., Antidepressants/antipsychotics, Systemic corticosteroids.

Treatment and study plan

Systane COMPLETE Lubricant Eye Drops

Drug

Active Ingredients: Propylene Glycol 0.6% Purpose: Lubricant

Other names: Alcon limited

Primary outcomes

  1. Ocular Surface Disease Index (OSDI)

    Time frame: Change in OSDI score at 2-week visit

    Change in OSDI score at 2-week visit

Secondary outcomes

  1. Non invasive tear break-up time (NITBUT)

    Time frame: NITBUT at 2-week and 3-month visits

    NITBUT at 2-week and 3-month visits

  2. Meibography

    Time frame: Meibography at 2-week and 3-month visits

    Meibography at 2-week and 3-month visits

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • Alcon Research

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 3, 2024
Registry last updated
Dec 2, 2024

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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