Dry EyeNCT03211351
Effects of Two Tear Substitutes in Patients With Dry Eye Syndrome
A study testing Liposic and Tears Naturale Forte in people with Dry Eye and Tear Film, run by Huaxia Eye Hospital Group 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, Tear Film, Lipid Layer
- What is being tested?
- Liposic and Tears Naturale Forte
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 25 Jan 2018
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Two Tear Substitutes in Patients With Dry Eye Syndrome
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, Tear Film, Lipid Layer, Liposic, Tears Naturale Forte
- Being tested
- 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
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 posted7 Jul 2017
- Study start1 Jul 2017
- Primary completion1 Dec 2017
- Study completion25 Jan 2018
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.
- 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
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huaxia Eye Hospital Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chi Zhang, MD.PhD, Principal investigator, Huaxia Eye Hospital of Foshan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211351
- Sponsor's protocol ID
- FSHX-001
- Status last verified
- Oct 2017
- First submitted
- 5 Jul 2017
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Two Tear Substitutes in Patients With Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT03211351
- Acronym / sponsor ID
- FSHX-001
- Conditions
- Dry Eye, Tear Film, Lipid Layer, Liposic, Tears Naturale Forte
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Huaxia Eye Hospital GroupUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 25 Jan 2018 (actual)
- First posted
- 7 Jul 2017 (actual)
- 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)
- 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
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 patien '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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
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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 principal investigator
Huaxia Eye Hospital of Foshan
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 and Tear Film, run by Huaxia Eye Hospital Group 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: finished, as of the sponsor's last update on 26 Feb 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 26 Feb 2018.