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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

Tracking Information
First Submitted Date  ICMJE December 12, 2016
First Posted Date  ICMJE December 14, 2016
Last Update Posted Date December 15, 2016
Study Start Date  ICMJE December 2016
Estimated Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2016)
  • scale of Schirmer I test [ Time Frame: up to 3 months after tear substitutes apply ]
  • scale of corneal fluorescein staining [ Time Frame: up to 3 months after tear substitutes apply ]
  • scale of noninvasive tear breakup time [ Time Frame: up to 3 months after tear substitutes apply ]
  • scale of tear meniscus height [ Time Frame: up to 3 months after tear substitutes apply ]
  • lipid layer grade [ Time Frame: up to 3 months after tear substitutes apply ]
  • questionnaire of ocular surface disease index [ Time Frame: up to 3 months after tear substitutes apply ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2016)		 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2016)		 subjective comfort [ Time Frame: up to 3 months after tear substitutes apply ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of the Clinical Effects of Two Tear Substitutes in Patients With Dry Eye Syndrome
Official Title  ICMJE Comparison of the Clinical Effects of Two Tear Substitutes in Patients With Dry Eye Syndrome
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dry Eye
Intervention  ICMJE
  • Drug: Liposic
    one eye of the participant recieved Lipoic
    Other Name: Carbomer
  • Drug: Tears Naturale Forte
    the other eye of the participant recieved Tears Naturale Forte
    Other Name: DEXTRAN/HYPROMELLOSE/GLYCERIN
Study Arms  ICMJE
  • Experimental: Liposic
    Liposic was applied to one eye of patients in this group
    Intervention: Drug: Liposic
  • Experimental: Tears Naturale Forte
    Tears Naturale Forte was applied to one eye of patients in this group
    Intervention: Drug: Tears Naturale Forte
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 12, 2016)		 50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2017
Estimated Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02992392
Other Study ID Numbers  ICMJE 2016-007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Xingwu Zhong, MD PhD, Sun Yat-sen University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sun Yat-sen University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xingwu Zhong Zhongshan Ophthalmic Center, Sun Yat-sen University
PRS Account Sun Yat-sen University
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP