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Effects of Two Tear Substitutes in Patients With Dry Eye Syndrome

H

Huaxia Eye Hospital Group

Status

Completed

Conditions

Liposic
Lipid Layer
Dry Eye
Tears Naturale Forte
Tear Film

Treatments

Drug: Tears Naturale Forte
Drug: Liposic

Study type

Interventional

Funder types

Other

Identifiers

NCT03211351
FSHX-001

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

95 patients

Sex

All

Ages

20 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Age range from 20 year to 40 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 patien '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

95 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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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