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

Not Applicable

• Conditions: Dry Eye
• Interventions: Drug: Liposic; Drug: Tears Naturale Forte

• Registration Number: NCT02992392
• Lead Sponsor: Sun Yat-sen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-12
• Study Start: 2016-12
• Study First Submitted: 2016-12-12
• Study First Submitted QC: 2016-12-12
• Study First Posted: 2016-12-14
• Last Update Submitted: 2016-12-14
• Last Update Posted: 2016-12-15
• Primary Completion: 2017-05
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liposic	Liposic	Liposic was applied to one eye of patients in this group
Tears Naturale Forte	Tears Naturale Forte	Tears Naturale Forte was applied to one eye of patients in this group

Primary Outcome Measures

Name	Time	Method
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
questionnaire of ocular surface disease index	up to 3 months after tear substitutes apply
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
lipid layer grade	up to 3 months after tear substitutes apply

Secondary Outcome Measures

Name	Time	Method
subjective comfort	up to 3 months after tear substitutes apply	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)

Trial Locations

Locations (1)

Hainan Eye Hospital, Zhongshan Ophthalmic Center of Sun Yat-sen University; 🇨🇳 Haikou, Hainan, China