Dry Eye
Conditions
Keywords
Tear film, Lipid layer, Liposic, 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
DRUGLiposic
one eye of the participant recieved Lipoic
the other eye of the participant recieved Tears Naturale Forte
Sponsors
Sun Yat-sen University
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| scale of noninvasive tear breakup time | up to 3 months after tear substitutes apply |
| scale of Schirmer I test | up to 3 months after tear substitutes apply |
| scale of corneal fluorescein staining | up to 3 months after tear substitutes apply |
| questionnaire of ocular surface disease index | up to 3 months after tear substitutes apply |
| scale of tear meniscus height | up to 3 months after tear substitutes apply |
| lipid layer grade | up to 3 months after tear substitutes apply |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| subjective comfort | 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) |
Countries
China
Contacts
Primary ContactChi Zhang, MD,PhD
Outcome results
None listed