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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: May 2017

Interventions

  • Drug: Liposic
    • one eye of the participant recieved Lipoic
  • Drug: Tears Naturale Forte
    • the other eye of the participant recieved Tears Naturale Forte

Arms, Groups and Cohorts

  • Experimental: Liposic
    • Liposic was applied to one eye of patients in this group
  • Experimental: Tears Naturale Forte
    • Tears Naturale Forte was applied to one eye of patients in this group

Clinical Trial Outcome Measures

Primary Measures

  • scale of Schirmer I test
    • Time Frame: up to 3 months after tear substitutes apply
  • scale of corneal fluorescein staining
    • Time Frame: up to 3 months after tear substitutes apply
  • scale of noninvasive tear breakup time
    • Time Frame: up to 3 months after tear substitutes apply
  • scale of tear meniscus height
    • Time Frame: up to 3 months after tear substitutes apply
  • lipid layer grade
    • Time Frame: up to 3 months after tear substitutes apply
  • questionnaire of ocular surface disease index
    • Time Frame: up to 3 months after tear substitutes apply

Secondary Measures

  • subjective comfort
    • Time Frame: up to 3 months after tear substitutes apply
    • Subjective comfort was established at each time-point by asking subjects, firstly, to relate their comfort to baseline in each eye (more comfortable/no different/less comfortable) . secondly, to express a preference for their more comfortable eye (right eye/left eye/no difference)

Participating in This Clinical Trial

Inclusion Criteria

  • Minimum age of 20 years(range from 20 year to 25 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 patient's lipid layer; – Known allergic sensitivity to any of the ingredients in Liposic or Tears Naturale Forte

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Sun Yat-sen University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Xingwu Zhong, MD PhD, Professor – Sun Yat-sen University
  • Overall Official(s)
    • Xingwu Zhong, Principal Investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
  • Overall Contact(s)
    • Chi Zhang, MD,PhD, mike0946@163.com

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