Effects of Two Tear Substitutes in Patients With Dry Eye Syndrome

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

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

Study Overview

• Status: Completed
• Conditions: Dry Eye; Tear Film; Lipid Layer; Liposic; Tears Naturale Forte
• Intervention / Treatment: Drug: Liposic; Drug: Tears Naturale Forte

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Foshan, Guangdong, China, 528000
      • Huaxia Eye Hosptial of Foshan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	Time Frame
subjective comfort	up to 3 months after tear substitutes apply

Collaborators and Investigators

• Sponsor: Huaxia Eye Hospital Group
• Investigators: Principal Investigator: Chi Zhang, MD.PhD, Huaxia Eye Hospital of Foshan

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): January 25, 2018

Study Registration Dates

• First Submitted: July 5, 2017
• First Submitted That Met QC Criteria: July 5, 2017
• First Posted (Actual): July 7, 2017

Study Record Updates

• Last Update Posted (Actual): February 26, 2018
• Last Update Submitted That Met QC Criteria: February 22, 2018
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Anticoagulants; Plasma Substitutes; Blood Substitutes; Dextrans
• Other Study ID Numbers: FSHX-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No