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Completed

NCT Number: NCT03211351

Effects of Two Tear Substitutes in Patients With Dry Eye Syndrome

With the potential to address evaporative dry eye, Liposic and Tears Naturale Forte have been developed in which phospholipid liposomes are delivered to the tear film via the surface of the closed eyelid. This study compare the effects of Liposic and Tears Naturale Forte application on the lipid and stability of the tear film in dry eye patients

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases Lipid Layer Liposic Tear Film Tears Naturale Forte

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huaxia Eye Hosptial of Foshan

Foshan, Guangdong, 528000, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age range from 20 year to 40 years
  • The value of OSDI is over 12
  • NBUT is less 5 seconds
  • Schirmer 1 test is less 10mm
  • The basical lipid layer grade is 1-2

Exclusion criteria

  • Any corneal,conjunctival, or eyelid abnormalities; conjunctivitis; current ocular infection; photophobia that may cause reflex tearing or difficulty in evaluating the patien 's lipid layer;
  • Known allergic sensitivity to any of the ingredients in Liposic or Tears Naturale Forte

Treatment and study plan

Liposic

Drug

one eye of the participant recieved Lipoic

Other names: Carbomer

Tears Naturale Forte

Drug

the other eye of the participant recieved Tears Naturale Forte

Other names: DEXTRAN/HYPROMELLOSE/GLYCERIN

Primary outcomes

  1. scale of Schirmer I test

    Time frame: up to 3 months after tear substitutes apply

  2. scale of corneal fluorescein staining

    Time frame: up to 3 months after tear substitutes apply

  3. scale of noninvasive tear breakup time

    Time frame: up to 3 months after tear substitutes apply

  4. scale of tear meniscus height

    Time frame: up to 3 months after tear substitutes apply

  5. lipid layer grade

    Time frame: up to 3 months after tear substitutes apply

  6. questionnaire of ocular surface disease index

    Time frame: up to 3 months after tear substitutes apply

Secondary outcomes

  1. subjective comfort

    Time frame: up to 3 months after tear substitutes apply

Sponsors and collaborators

Lead sponsor

Huaxia Eye Hospital Group

Other

Registry information

Official study title

Comparison of the Effects of Two Tear Substitutes in Patients With Dry Eye Syndrome

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Jul 7, 2017
Registry last updated
Feb 26, 2018

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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