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Effects of Two Tear Substitutes in Patients With Dry Eye Syndrome
This study is currently recruiting participants.
Verified July 2017 by Huaxia Eye Hospital Group
Sponsor:
Huaxia Eye Hospital Group
Information provided by (Responsible Party):
Huaxia Eye Hospital Group
ClinicalTrials.gov Identifier:
NCT03211351
First received: July 5, 2017
Last updated: NA
Last verified: July 2017
History: No changes posted
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Purpose
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 | Intervention |
|---|---|
| Dry Eye Tear Film Lipid Layer Liposic Tears Naturale Forte | Drug: Liposic Drug: Tears Naturale Forte |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Outcomes Assessor Primary Purpose: Treatment |
| Official Title: | Comparison of the Effects of Two Tear Substitutes in Patients With Dry Eye Syndrome |
Resource links provided by NLM:
Further study details as provided by Huaxia Eye Hospital Group:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- subjective comfort [ Time Frame: up to 3 months after tear substitutes apply ]
| Estimated Enrollment: | 60 |
| Actual Study Start Date: | July 1, 2017 |
| Estimated Study Completion Date: | October 30, 2017 |
| Estimated Primary Completion Date: | August 30, 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 20 Years to 40 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03211351
Please refer to this study by its ClinicalTrials.gov identifier: NCT03211351
Contacts
| Contact: Chi Zhang, MD.PhD | +86(757)83908467 | zhangc94@huaxiaeye.com | |
| Contact: Gangping Zhao, MD | +86(757)83903600 | gpzhao@126.com |
Locations
| China, Guangdong | |
| Huaxia Eye Hosptial of Foshan | Recruiting |
| Foshan, Guangdong, China, 528000 | |
| Contact: Chi Zhang, MD,PhD +86(757)83908461 zhangc94@huaxiaeye.com | |
Sponsors and Collaborators
Huaxia Eye Hospital Group
Investigators
| Principal Investigator: | Chi Zhang, MD.PhD | Huaxia Eye Hospital of Foshan |
More Information
| Responsible Party: | Huaxia Eye Hospital Group |
| ClinicalTrials.gov Identifier: | NCT03211351 History of Changes |
| Other Study ID Numbers: |
FSHX-001 |
| Study First Received: | July 5, 2017 |
| Last Updated: | July 5, 2017 |
| 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 | |
Additional relevant MeSH terms:
|
Keratoconjunctivitis Sicca Dry Eye Syndromes Keratoconjunctivitis Conjunctivitis Conjunctival Diseases Eye Diseases Keratitis Corneal Diseases Lacrimal Apparatus Diseases |
Dextrans Glycerol Anticoagulants Plasma Substitutes Blood Substitutes Cryoprotective Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on July 11, 2017