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

Study Overview
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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.

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

Conditions
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Dry Eye

Intervention / Treatment
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* Drug: Liposic
* Drug: Tears Naturale Forte


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liposic<br>Liposic was applied to one eye of patients in this group | Drug: Liposic<br>* one eye of the participant recieved Lipoic<br>* Other names: Carbomer;|
| Experimental: Tears Naturale Forte<br>Tears Naturale Forte was applied to one eye of patients in this group | Drug: Tears Naturale Forte<br>* the other eye of the participant recieved Tears Naturale Forte<br>* Other names: DEXTRAN/HYPROMELLOSE/GLYCERIN;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tear film, Lipid layer, Liposic, Tears Naturale Forte