NCT01562795

Brief Summary

This clinical trial is to investigate whether nonsteroid anti-inflammatory drops have therapeutic effect on moderate to severe dry eye patients.And compare the efficacy of the two nonsteroid anti-inflammatory drops with topical corticosteroids.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2012

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 26, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

January 3, 2014

Status Verified

January 1, 2014

Enrollment Period

3 months

First QC Date

March 22, 2012

Last Update Submit

January 2, 2014

Conditions

Moderate to Severe Dry Eye Syndrome

Outcome Measures

Primary Outcomes (1)

  • tear osmolarity

    Day 0, Day 14

Secondary Outcomes (4)

  • corneal staining

    0 day,7th day and 14th day after treatment

  • Schirmer test(without anaesthesia)

    0 day,7th day,14th day after treatment

  • tear film breakup time(TBUT)

    0 day,7th day and 14th day after treatment

  • meibomian gland function

    0 day,7th day and 14th day after treatment

Study Arms (4)

group 1

EXPERIMENTAL
Drug: nonsteroid anti-inflammatory drops

group 2

EXPERIMENTAL
Drug: nonsteroid anti-inflammatory drops

group 3

EXPERIMENTAL
Drug: corticosteroids

group 4

OTHER
Drug: artificial tear substitute

Interventions

nonsteroid anti-inflammatory dropsDRUG

nonsteroid anti-inflammatory drops plus artificial tear substitute

Also known as: prunoprefen
group 1
corticosteroidsDRUG

corticosteroids plus artificial tear substitute

Also known as: Fluorometholone
group 3
artificial tear substituteDRUG

artificial tear substitute alone

group 4

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • moderate to severe dry eye syndrome
  • tear film breakup time \>0 second and ≤5 seconds,or schirmer test(no anaesthesia)≥2mm/5min and ≤5mm/5min
  • corneal staining≥3 scores

You may not qualify if:

  • allergic to any composition of the drugs under experiment
  • previous use of anti-inflammatory drugs or immunosuppressive agent
  • viral,bacterial or fungal infection of the eye
  • eyelid anomaly
  • glaucoma or high IOP
  • significant meibomian gland dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Hospital, Wenzhou Medical College

Wenzhou, Zhejiang, 325027, China

Location

MeSH Terms

Interventions

Adrenal Cortex HormonesFluorometholone

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone AntagonistsPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Wei Chen, MD,PhD

    Eye Hospital, Wenzhou Medical College, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 22, 2012

First Posted

March 26, 2012

Study Start

March 1, 2012

Primary Completion

June 1, 2012

Study Completion

July 1, 2012

Last Updated

January 3, 2014

Record last verified: 2014-01

Locations

CN(1)