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

NCT ID: NCT02992392

Last Updated: 2016-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Dry Eye

Keywords

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Tear film Lipid layer Liposic Tears Naturale Forte

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Liposic

Liposic was applied to one eye of patients in this group

Group Type EXPERIMENTAL

Liposic

Intervention Type DRUG

one eye of the participant recieved Lipoic

Tears Naturale Forte

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

Group Type EXPERIMENTAL

Tears Naturale Forte

Intervention Type DRUG

the other eye of the participant recieved Tears Naturale Forte

Interventions

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Liposic

one eye of the participant recieved Lipoic

Intervention Type DRUG

Tears Naturale Forte

the other eye of the participant recieved Tears Naturale Forte

Intervention Type DRUG

Other Intervention Names

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Carbomer DEXTRAN/HYPROMELLOSE/GLYCERIN

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Xingwu Zhong, MD PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xingwu Zhong

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

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

Haikou, Hainan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chi Zhang, MD,PhD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Xingwu Zhong, MD,PhD

Role: primary

Other Identifiers

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2016-007

Identifier Type: -

Identifier Source: org_study_id