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

December 14, 2016 updated by: Xingwu Zhong, MD PhD, Sun Yat-sen University
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hainan
      • Haikou, Hainan, China, 570311
        • Recruiting
        • Hainan Eye Hospital, Zhongshan Ophthalmic Center of Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Liposic
Liposic was applied to one eye of patients in this group
Drug: Liposic
one eye of the participant recieved Lipoic
Other Names:
  • Carbomer
EXPERIMENTAL: Tears Naturale Forte
Tears Naturale Forte was applied to one eye of patients in this group
Drug: Tears Naturale Forte
the other eye of the participant recieved Tears Naturale Forte
Other Names:
  • DEXTRAN/HYPROMELLOSE/GLYCERIN

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
up to 3 months after tear substitutes apply

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Xingwu Zhong, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (ANTICIPATED)

May 1, 2017

Study Completion (ANTICIPATED)

June 1, 2017

Study Registration Dates

First Submitted

December 12, 2016

First Submitted That Met QC Criteria

December 12, 2016

First Posted (ESTIMATE)

December 14, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 15, 2016

Last Update Submitted That Met QC Criteria

December 14, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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