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

Primary Purpose

Dry Eye

Status

Unknown status

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 focused on measuring Tear film, Lipid layer, Liposic, Tears Naturale Forte

Eligibility Criteria

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

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

Sites / Locations

Hainan Eye Hospital, Zhongshan Ophthalmic Center of Sun Yat-sen UniversityRecruiting

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

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)

Full Information

NCT ID

NCT02992392

First Posted

December 12, 2016

Last Updated

December 14, 2016

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT02992392

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Unknown status

Study Start Date

December 2016 (undefined)

Primary Completion Date

May 2017 (Anticipated)

Study Completion Date

June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

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

Keywords

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

50 (Anticipated)

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