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Effects of Two Tear Substitutes in Patients With Dry Eye Syndrome

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03211351
Enrollment
95
Registered
2017-07-07
Start date
2017-07-01
Completion date
2018-01-25
Last updated
2018-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye, Lipid Layer, Liposic, Tear Film, Tears Naturale Forte

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

Interventions

one eye of the participant recieved Lipoic

the other eye of the participant recieved Tears Naturale Forte

Sponsors

Huaxia Eye Hospital Group
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
scale of noninvasive tear breakup timeup to 3 months after tear substitutes apply
scale of Schirmer I testup to 3 months after tear substitutes apply
scale of corneal fluorescein stainingup to 3 months after tear substitutes apply
questionnaire of ocular surface disease indexup to 3 months after tear substitutes apply
scale of tear meniscus heightup to 3 months after tear substitutes apply
lipid layer gradeup to 3 months after tear substitutes apply

Secondary

MeasureTime frame
subjective comfortup to 3 months after tear substitutes apply

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026