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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02992392
Recruitment Status : Unknown
Verified December 2016 by Xingwu Zhong, MD PhD, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : December 14, 2016
Last Update Posted : December 15, 2016
Sponsor:
Information provided by (Responsible Party):
Xingwu Zhong, MD PhD, Sun Yat-sen University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dry Eye Drug: Liposic Drug: Tears Naturale Forte Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of the Clinical Effects of Two Tear Substitutes in Patients With Dry Eye Syndrome
Study Start Date : December 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arms and Interventions
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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 Name: 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 Name: DEXTRAN/HYPROMELLOSE/GLYCERIN


Outcome Measures
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Primary Outcome Measures :
  1. scale of Schirmer I test [ Time Frame: up to 3 months after tear substitutes apply ]
  2. scale of corneal fluorescein staining [ Time Frame: up to 3 months after tear substitutes apply ]
  3. scale of noninvasive tear breakup time [ Time Frame: up to 3 months after tear substitutes apply ]
  4. scale of tear meniscus height [ Time Frame: up to 3 months after tear substitutes apply ]
  5. lipid layer grade [ Time Frame: up to 3 months after tear substitutes apply ]
  6. questionnaire of ocular surface disease index [ Time Frame: up to 3 months after tear substitutes apply ]

Secondary Outcome Measures :
  1. subjective comfort [ Time Frame: 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)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02992392


Contacts
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Contact: Chi Zhang, MD,PhD mike0946@163.com

Locations
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China, Hainan
Hainan Eye Hospital, Zhongshan Ophthalmic Center of Sun Yat-sen University Recruiting
Haikou, Hainan, China, 570311
Contact: Xingwu Zhong, MD,PhD    +86(898)68628481    zhongxwu@mail.sysu.edu.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Xingwu Zhong Zhongshan Ophthalmic Center, Sun Yat-sen University
More Information
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Responsible Party: Xingwu Zhong, MD PhD, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02992392    
Other Study ID Numbers: 2016-007
First Posted: December 14, 2016    Key Record Dates
Last Update Posted: December 15, 2016
Last Verified: December 2016
Keywords provided by Xingwu Zhong, MD PhD, Sun Yat-sen University:
Tear film
Lipid layer
Liposic
Tears Naturale Forte
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
 Keratitis
Corneal Diseases
Dextrans
Anticoagulants
Plasma Substitutes
Blood Substitutes