NCT01959854

Brief Summary

The purpose of this study is to evaluate the effect of an ophthalmic solution containing 0.2% xanthan gum in reducing symptoms and signs of dry eye as well as tear film markers of oxidative stress.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

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

September 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 7, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 10, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 16, 2014

Status Verified

October 1, 2014

Enrollment Period

1.1 years

First QC Date

October 7, 2013

Last Update Submit

October 15, 2014

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

  • Ocular surface disease index (OSDI)

    OSDI is a questionnaire including 12 questions to be asked to the patient. From the questionnaire it will be possible to calculate the OSDI score which is a reliable and valid measurement for dry eye severity.

    change from baseline OSDI at 30 days

Secondary Outcomes (2)

  • Visual analogue rating scale (VARS)

    change from baseline VARS at 30 days

  • Fluorescein staining

    change from baseline staining at 30 days

Study Arms (2)

carboxymethylcellulose

ACTIVE COMPARATOR

1 drop in each eye four times a day for 30 days

Device: carboxymethylcellulose

xanthan gum

EXPERIMENTAL

1 drop in each eye four times a day for 30 days

Device: xanthan gum

Interventions

carboxymethylcelluloseDEVICE

0.25% carboxymethylcellulose preservative free

Also known as: THERADROP
carboxymethylcellulose
xanthan gumDEVICE

0.2% xanthan gum preservative free

Also known as: OXISTOP
xanthan gum

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ocular Surface Disease Index \> 12\<23 and age \>59 yrs

You may not qualify if:

  • contact lens wear and use of other ophthalmic solutions with the exception of artificial tears

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Messina

Messina, Italy

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Pasquale Aragona, MD

    University of Messina (ITALY)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2013

First Posted

October 10, 2013

Study Start

September 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

October 16, 2014

Record last verified: 2014-10

Locations

IT(1)