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

Sponsor

Sun Yat-sen University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02992392

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

8.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Drug: Liposic Drug: Tears Naturale Forte	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2016

Anticipated Primary Completion Date :

May 1, 2017

Anticipated Study Completion Date :

Jun 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

subjective comfort [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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