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

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02992392
• Other study ID #: 2016-007
• Status: Recruiting
• Phase: N/A
• First received: December 12, 2016
• Last updated: December 14, 2016
• Start date: December 2016
• Est. completion date: June 2017

Study information

• Verified date: December 2016
• Source: Sun Yat-sen University
• Contact: Chi Zhang, MD,PhD
• Email: mike0946[@]163.com
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• 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: Recruiting
• Enrollment: 50
• Est. completion date: June 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 40 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

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	Hainan Eye Hospital, Zhongshan Ophthalmic Center of Sun Yat-sen University	Haikou	Hainan

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

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	No
Primary	scale of corneal fluorescein staining		up to 3 months after tear substitutes apply	No
Primary	scale of noninvasive tear breakup time		up to 3 months after tear substitutes apply	No
Primary	scale of tear meniscus height		up to 3 months after tear substitutes apply	No
Primary	lipid layer grade		up to 3 months after tear substitutes apply	No
Primary	questionnaire of ocular surface disease index		up to 3 months after tear substitutes apply	No
Secondary	subjective comfort	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)	up to 3 months after tear substitutes apply	No