Efficacy of a New Nanoemulsion Artificial Tear Targeting Dry Eye Disease

Last updated: November 27, 2024
Sponsor: The Hong Kong Polytechnic University
Overall Status: Completed

Phase

2

Condition

Dry Eyes

Sjogren's Syndrome

Dry Eye Disease

Treatment

Systane COMPLETE Lubricant Eye Drops

Clinical Study ID

NCT06188260
20230209004
  • Ages 20-50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 20-50 years old

  2. Best corrected distance visual acuity ≥ 6/9

  3. Mild to moderate OSDI score 13-32

  4. Any one of the objective test positive (NITBUT/Corneal fluorescein staining/Tearosmolarity)

Exclusion

Exclusion Criteria:

  1. Any active ocular infections

  2. Inflammations or anomalies in the eyelid

  3. Uncontrolled, newly diagnosed systemic diseases or with modified long-termmedications within 6 months that are known to affect tear profile.

  4. Pregnancy and breastfeeding

  5. Contact lens wearers are required to stop contact lenses wear for at least 1 weekbefore the evaluation.

  6. Subjects who are using artificial tears or other eyedrops will be excluded.

  7. Subjects who are taking systemic drugs that may cause dry eye, e.g.,Antidepressants/antipsychotics, Systemic corticosteroids.

Study Design

Total Participants: 31
Treatment Group(s): 1
Primary Treatment: Systane COMPLETE Lubricant Eye Drops
Phase: 2
Study Start date:
January 16, 2024
Estimated Completion Date:
November 04, 2024

Study 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.

Connect with a study center

  • Thomas LAM

    Hong Kong, 999077
    Hong Kong

    Site Not Available

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