NCT03211351

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 7, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2018

Completed
Last Updated

February 26, 2018

Status Verified

October 1, 2017

Enrollment Period

5 months

First QC Date

July 5, 2017

Last Update Submit

February 22, 2018

Conditions

Dry EyeTear FilmLipid LayerLiposicTears Naturale Forte

Outcome Measures

Primary Outcomes (6)

  • 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

  • scale of noninvasive tear breakup time

    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

  • questionnaire of ocular surface disease index

    up to 3 months after tear substitutes apply

Secondary Outcomes (1)

  • subjective comfort

    up to 3 months after tear substitutes apply

Study Arms (2)

Liposic

EXPERIMENTAL

Liposic was applied to one eye of patients in this group

Drug: Liposic

Tears Naturale Forte

EXPERIMENTAL

Tears Naturale Forte was applied to one eye of patients in this group

Drug: Tears Naturale Forte

Interventions

LiposicDRUG

one eye of the participant recieved Lipoic

Also known as: Carbomer
Liposic
Tears Naturale ForteDRUG

the other eye of the participant recieved Tears Naturale Forte

Also known as: DEXTRAN/HYPROMELLOSE/GLYCERIN
Tears Naturale Forte

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huaxia Eye Hosptial of Foshan

Foshan, Guangdong, 528000, China

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

carbomerDextrans

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

GlucansBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydrates

Study Officials

  • Chi Zhang, MD.PhD

    Huaxia Eye Hospital of Foshan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2017

First Posted

July 7, 2017

Study Start

July 1, 2017

Primary Completion

December 1, 2017

Study Completion

January 25, 2018

Last Updated

February 26, 2018

Record last verified: 2017-10

Locations

CN(1)