Moderate to Severe Dry Eye SyndromeNCT01562795

Efficacy of Nonsteroidal Anti-inflammatory Drugs in Treatment of Moderate and Severe Dry Eye Disease

A study testing nonsteroid anti-inflammatory drops, corticosteroids and artificial tear substitute in people with Moderate to Severe Dry Eye Syndrome, run by Wenzhou Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Moderate to Severe Dry Eye Syndrome
What is being tested?: nonsteroid anti-inflammatory drops, corticosteroids and artificial tear substitute
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteChina
Study dates: Mar 2012to Jul 2012
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

Eye Hospital, Wenzhou Medical College
Wenzhou, Zhejiang, 325027

Other trials in China

About this study

Conditions: Moderate to Severe Dry Eye Syndrome
Being tested: nonsteroid anti-inflammatory drops, corticosteroids, artificial tear substitute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

nonsteroid anti-inflammatory dropsDrug
Also called prunoprefen
nonsteroid anti-inflammatory drops plus artificial tear substitute
nonsteroid anti-inflammatory dropsDrug
Also called bronuck
nonsteroid anti-inflammatory drops plus artificial tear substitute
corticosteroidsDrug
Also called Fluorometholone
corticosteroids plus artificial tear substitute
artificial tear substituteDrug
artificial tear substitute alone

Study groups in NCT01562795
Study group	Role	What they receive
group 1	Experimental	Not described Receives: Drug: nonsteroid anti-inflammatory drops
group 2	Experimental	Not described Receives: Drug: nonsteroid anti-inflammatory drops
group 3	Experimental	Not described Receives: Drug: corticosteroids
group 4	Other	Not described Receives: Drug: artificial tear substitute

What is being measured

The primary outcome is the main question the study is designed to answer.

tear osmolarity
Measured: Day 0, Day 14

Secondary outcomes (4)

corneal staining
Measured: 0 day,7th day and 14th day after treatment
Schirmer test(without anaesthesia)
Measured: 0 day,7th day,14th day after treatment
tear film breakup time(TBUT)
Measured: 0 day,7th day and 14th day after treatment
meibomian gland function
Measured: 0 day,7th day and 14th day after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2012Jul 2012

First posted26 Mar 2012 (estimated)
Study startMar 2012
Primary completionJun 2012
Study completionJul 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Moderate to Severe Dry Eye SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01562795
Sponsor's protocol ID: Xzhou
Status last verified: Jan 2014
First submitted: 22 Mar 2012
Last updated: 3 Jan 2014
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
Nipocalimab in Moderate to Severe Sjogren's Disease
Sjogrens Syndrome
RecruitingPhase 3
Phase III Study of OT202 in Treating Moderate to Severe Dry Eye
Dry Eye
Not yet recruitingPhase 2
Exploratory Study on the Efficacy and Safety of Low-Dose Blinatumomab in the Treatment of Moderate to Severe Primary Sjögren's Syndrome
Primary Sjögren's Syndrome (pSS)
Recruiting
A Study to Evaluate the Performance and Safety of Artelac® Complete MDO® Versus VISMED® MULTI Eye Drops in the Management of Moderate to Severe Dry Eye Disease
Dry Eye
Not yet recruitingPhase 2
A Study of IBI355 in Participants With Moderate-to-Severe Sjögren's Disease
Sjögren's Disease

All Moderate to Severe Dry Eye Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Nonsteroidal Anti-inflammatory Drugs in Treatment of Moderate and Severe Dry Eye Disease
ClinicalTrials.gov ID: NCT01562795
Acronym / sponsor ID: Xzhou
Conditions: Moderate to Severe Dry Eye Syndrome
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Wenzhou Medical UniversityUniversity, hospital or other
Study start: Mar 2012
Primary completion: Jun 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 26 Mar 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
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

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
nonsteroid anti-inflammatory dropsAlso: prunoprefennonsteroid anti-inflammatory drops plus artificial tear substitute	Drug	group 1
nonsteroid anti-inflammatory dropsAlso: bronucknonsteroid anti-inflammatory drops plus artificial tear substitute	Drug	group 2
corticosteroidsAlso: Fluorometholonecorticosteroids plus artificial tear substitute	Drug	group 3
artificial tear substituteartificial tear substitute alone	Drug	group 4

Primary outcome

tear osmolarity
Time frame: Day 0, Day 14

4 secondary outcomes

corneal staining
Time frame: 0 day,7th day and 14th day after treatment
Schirmer test(without anaesthesia)
Time frame: 0 day,7th day,14th day after treatment
tear film breakup time(TBUT)
Time frame: 0 day,7th day and 14th day after treatment
meibomian gland function
Time frame: 0 day,7th day and 14th day after treatment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2014.

Related trials for Moderate to Severe Dry Eye Syndrome

Active, not recruitingPhase 3
Nipocalimab in Moderate to Severe Sjogren's Disease
Sjogrens Syndrome
RecruitingPhase 3
Phase III Study of OT202 in Treating Moderate to Severe Dry Eye
Dry Eye
Not yet recruitingPhase 2
Exploratory Study on the Efficacy and Safety of Low-Dose Blinatumomab in the Treatment of Moderate to Severe Primary Sjögren's Syndrome
Primary Sjögren's Syndrome (pSS)
Recruiting
A Study to Evaluate the Performance and Safety of Artelac® Complete MDO® Versus VISMED® MULTI Eye Drops in the Management of Moderate to Severe Dry Eye Disease
Dry Eye
Not yet recruitingPhase 2
A Study of IBI355 in Participants With Moderate-to-Severe Sjögren's Disease
Sjögren's Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Wei Chen, MD,PhD principal investigator

Eye Hospital, Wenzhou Medical College, China

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

tear osmolarity (time frame: Day 0, Day 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01562795.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2014.