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Effects of Two Tear Substitutes in Patients With Dry Eye Syndrome

Primary Purpose

Dry Eye, Tear Film, Lipid Layer

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Liposic

Tears Naturale Forte

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Huaxia Eye Hosptial of Foshan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Liposic

Tears Naturale Forte

Arm Description

Liposic was applied to one eye of patients in this group

Tears Naturale Forte was applied to one eye of patients in this group

Outcomes

Primary Outcome Measures

scale of Schirmer I test

scale of corneal fluorescein staining

scale of noninvasive tear breakup time

scale of tear meniscus height

lipid layer grade

questionnaire of ocular surface disease index

Secondary Outcome Measures

subjective comfort

Full Information

NCT ID

NCT03211351

First Posted

July 5, 2017

Last Updated

February 22, 2018

Sponsor

Huaxia Eye Hospital Group

1. Study Identification

Unique Protocol Identification Number

NCT03211351

Brief Title

Effects of Two Tear Substitutes in Patients With Dry Eye Syndrome

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

July 1, 2017 (Actual)

Primary Completion Date

December 1, 2017 (Actual)

Study Completion Date

January 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Huaxia Eye Hospital Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye, Tear Film, Lipid Layer, Liposic, Tears Naturale Forte

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

95 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Liposic

Arm Type

Experimental

Arm Description

Liposic was applied to one eye of patients in this group

Arm Title

Tears Naturale Forte

Arm Type

Experimental

Arm Description

Tears Naturale Forte was applied to one eye of patients in this group

Intervention Type

Drug

Intervention Name(s)

Liposic

Other Intervention Name(s)

Carbomer

Intervention Description

one eye of the participant recieved Lipoic

Intervention Type

Drug

Intervention Name(s)

Tears Naturale Forte

Other Intervention Name(s)

DEXTRAN/HYPROMELLOSE/GLYCERIN

Intervention Description

the other eye of the participant recieved Tears Naturale Forte

Primary Outcome Measure Information:

Title

scale of Schirmer I test

Time Frame