Effects of Two Tear Substitutes in Patients With Dry Eye Syndrome

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03211351
• Other study ID #: FSHX-001
• Status: Completed
• Phase: N/A
• First received: July 5, 2017
• Last updated: February 22, 2018
• Start date: July 1, 2017
• Est. completion date: January 25, 2018

Study information

• Verified date: October 2017
• Source: Huaxia Eye Hospital Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: January 25, 2018
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Lipid Layer
• Liposic
• Tear Film
• Tears Naturale Forte

Intervention

Drug:
• Liposic
one eye of the participant recieved Lipoic
• Tears Naturale Forte
the other eye of the participant recieved Tears Naturale Forte

Locations

Country	Name	City	State
China	Huaxia Eye Hosptial of Foshan	Foshan	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Huaxia Eye Hospital Group

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	scale of Schirmer I test		up to 3 months after tear substitutes apply
Primary	scale of corneal fluorescein staining		up to 3 months after tear substitutes apply
Primary	scale of noninvasive tear breakup time		up to 3 months after tear substitutes apply
Primary	scale of tear meniscus height		up to 3 months after tear substitutes apply
Primary	lipid layer grade		up to 3 months after tear substitutes apply
Primary	questionnaire of ocular surface disease index		up to 3 months after tear substitutes apply
Secondary	subjective comfort		up to 3 months after tear substitutes apply