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

Sun Yat-sen University

Status: Unknown

Conditions: Dry Eye

Treatments: Drug: Liposic; Drug: Tears Naturale Forte

Study type: Interventional

Funder types: Other

Identifiers

NCT02992392

2016-007

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 20 to 40 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Liposic

Experimental group

Description:

Liposic was applied to one eye of patients in this group

Treatment:

Drug: Liposic

Tears Naturale Forte

Experimental group

Description:

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

Treatment:

Drug: Tears Naturale Forte