Dry EyeNCT02992392
Comparison of the Clinical Effects of Two Tear Substitutes in Patients With Dry Eye Syndrome
A study testing Liposic and Tears Naturale Forte in people with Dry Eye, run by Sun Yat-sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Liposic and Tears Naturale Forte
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Chi Zhang, MD,PhD contact
China1 site, 1 recruiting
- Recruiting
Hainan Eye Hospital, Zhongshan Ophthalmic Center of Sun Yat-sen University
Haikou, Hainan, 570311
Xingwu Zhong, MD,PhD, +86(898)68628481, zhongxwu@mail.sysu.edu.cn
About this study
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.
- Conditions
- Dry Eye
- Being tested
- Liposic, Tears Naturale Forte
- Keywords
- Tear film, Lipid layer, Liposic, Tears Naturale Forte
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiposicDrug
Also called Carbomer
one eye of the participant recieved Lipoic
Tears Naturale ForteDrug
Also called DEXTRAN/HYPROMELLOSE/GLYCERIN
the other eye of the participant recieved Tears Naturale Forte
| Study group | Role | What they receive |
|---|---|---|
| Liposic | Experimental | Liposic was applied to one eye of patients in this group Receives: Drug: Liposic |
| Tears Naturale Forte | Experimental | Tears Naturale Forte was applied to one eye of patients in this group Receives: Drug: Tears Naturale Forte |
What is being measured
The primary outcome is the main question the study is designed to answer.
scale of Schirmer I test
Measured: up to 3 months after tear substitutes apply
scale of corneal fluorescein staining
Measured: up to 3 months after tear substitutes apply
scale of noninvasive tear breakup time
Measured: up to 3 months after tear substitutes apply
scale of tear meniscus height
Measured: up to 3 months after tear substitutes apply
lipid layer grade
Measured: up to 3 months after tear substitutes apply
questionnaire of ocular surface disease index
Measured: up to 3 months after tear substitutes apply
Secondary outcomes (1)
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)
Measured: up to 3 months after tear substitutes apply
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionMay 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingwu Zhong, MD PhD, Sun Yat-sen University
- Investigators
- Xingwu Zhong, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02992392
- Sponsor's protocol ID
- 2016-007
- Status last verified
- Dec 2016
- First submitted
- 12 Dec 2016
- Last updated
- 15 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Clinical Effects of Two Tear Substitutes in Patients With Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT02992392
- Acronym / sponsor ID
- 2016-007
- Conditions
- Dry Eye
- Keywords
- Tear film, Lipid layer, Liposic, Tears Naturale Forte
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 14 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposic | Experimental | Drug: LiposicLiposic was applied to one eye of patients in this group |
| Tears Naturale Forte | Experimental | Drug: Tears Naturale ForteTears Naturale Forte was applied to one eye of patients in this group |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiposicAlso: Carbomerone eye of the participant recieved Lipoic | Drug | Liposic |
| Tears Naturale ForteAlso: DEXTRAN/HYPROMELLOSE/GLYCERINthe other eye of the participant recieved Tears Naturale Forte | Drug | Tears Naturale Forte |
Primary outcome
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
1 secondary outcome
subjective comfort
Time frame: up to 3 months after tear substitutes apply
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2016.
Related trials for Dry Eye
Not yet recruitingPhase 2
Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments
Dry Eye Disease (DED), Graft-Versus-Host Disease(GVHD)
Not yet recruiting
LacriFill Canalicular Occlusion for Dry Eye After LASIK
Dry Eye Syndrome
Active, not recruiting
Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
Meibomian Gland Dysfunction, Dry Eye Disease
Not yet recruitingEarly Phase 1
a Novel siRNA Eyedrops for DED Treatment
Dry Eye
Recruiting
Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease
Dry Eye Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chi Zhang, MD,PhD contact
Xingwu Zhong principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liposic and Tears Naturale Forte in people with Dry Eye, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chi Zhang, MD,PhD (mike0946@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
scale of Schirmer I test (time frame: up to 3 months after tear substitutes apply). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2016; AzTrials last refreshed its copy on 8 Nov 2026.