NCT02992392

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

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

December 15, 2016

Status Verified

December 1, 2016

Enrollment Period

5 months

First QC Date

December 12, 2016

Last Update Submit

December 14, 2016

Conditions

Dry Eye

Keywords

Tear 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:

  • 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

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 patient'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)

Hainan Eye Hospital, Zhongshan Ophthalmic Center of Sun Yat-sen University

Haikou, Hainan, 570311, China

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

carbomerDextrans

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

GlucansBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydrates

Study Officials

  • Xingwu Zhong

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi Zhang, MD,PhD

CONTACT

mike0946@163.com

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
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 12, 2016

First Posted

December 14, 2016

Study Start

December 1, 2016

Primary Completion

May 1, 2017

Study Completion

June 1, 2017

Last Updated

December 15, 2016

Record last verified: 2016-12

Locations

CN(1)