Dry EyesNCT01450787

Prevalence of Dry Eyes in Diabetics Compared to Non Diabetics

An observational study of Dry Eyes, run by COA Research Foundation, INC at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The purpose is to compare the prevalence of dry eyes in diabetics and non diabetics. This might help identify a group of patients at greater risk for dry eye complications. Diabetics have been shown to have poor ocular surface healing and might benefit from dry eye therapy earlier if they are shown to be at greater… Read more about this study

Who is it for?: Ages 40 years and olderHealthy volunteers can take part
Conditions the study is for: Dry Eyes
How many people: 63 participants
Where: 1 siteUnited States
Study dates: Jan 2012to Jun 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 40 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Existing clinic population from our practice

Who may be able to join

50 patients with diabetes, 25 without diabetes over the age of 40

Who cannot join

current use of glaucoma drops or currently within the postoperative period from eye surgery

Trial locations and contacts

1 site in 1 country.

United States1 site

Columbus Ophthalmalogy Associates
Columbus, Ohio, 43213

Other trials in United States

About this study

Read the detailed description

Dry eye disease is one of the most common eye problems seen in ophthalmology. Diabetics are at high risk for multiple eye problems, including retinopathy and glaucoma. They also have been shown to have poor ocular surface healing. I would like to evaluate the prevalence of dry eye disease in diabetics to see if they are also at greater risk for the known complications of dry eye disease. If so, they might benefit from early intervention.

Conditions: Dry Eyes
Keywords: dry eyes, diabetes
Medical subject headings: Dry Eye Syndromes, Diabetes Mellitus

What participants receive

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

Study groups in NCT01450787
Study group	Role	What they receive
diabetics		diabetics
non diabetics		non diabetics

What is being measured

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

Conjunctival Staining Score
Conjunctival staining with lissamine green dye is measured at the time of the evaluation on a scale from 0 to 5 using the oxford scoring system, with 5 being the most severe staining.
Measured: at the time of the evaluation

Secondary outcomes (1)

Tear Film Osmolarity
The tear film osmolarity is measured at the time of the exam.
Measured: at the time of the exam

Timeline

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

Jan 2012Jun 2012

First posted12 Oct 2011 (estimated)
Study startJan 2012
Primary completionJun 2012
Study completionJun 2012

Why it stopped: Principle investigator changed practice location and discontinued study

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dry EyesStudies 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: Observational
Observational model: Case-control
Time perspective: Cross-sectional
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01450787
Sponsor's protocol ID: 000322
Status last verified: Aug 2013
First submitted: 10 Oct 2011
Last updated: 30 Sep 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

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All Dry Eyes trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prevalence of Dry Eyes in Diabetics Compared to Non Diabetics
ClinicalTrials.gov ID: NCT01450787
Acronym / sponsor ID: 000322
Conditions: Dry Eyes
Keywords: dry eyes, diabetes
Study type: Observational
Recruitment status: TerminatedReason stopped: Principle investigator changed practice location and discontinued study
Enrolment: 63 participants (actual)
Lead sponsor: COA Research Foundation, INCUniversity, hospital or other
Collaborators: Allergan
Study start: Jan 2012
Primary completion: Jun 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 12 Oct 2011 (estimated)
Results: Posted 30 Sep 2013

Clinical summary

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

Detailed description

Study design

Observational model: Case-control
Time perspective: Cross-sectional
Number of arms: 2

Arm	Type	Receives
diabetics	–	–diabetics
non diabetics	–	–non diabetics

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Existing clinic population from our practice

Key inclusion criteria (1 listed)

50 patients with diabetes, 25 without diabetes over the age of 40

Key exclusion criteria (1 listed)

current use of glaucoma drops or currently within the postoperative period from eye surgery

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

Primary outcome

Conjunctival Staining Score
Time frame: at the time of the evaluation
Conjunctival staining with lissamine green dye is measured at the time of the evaluation on a scale from 0 to 5 using the oxford scoring system, with 5 being the most severe staining.

1 secondary outcome

Tear Film Osmolarity
Time frame: at the time of the exam

Results and safety

Results posted to the registry on 30 Sep 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Diabetics	38	38
Non Diabetics	25	25

Primary outcome: Conjunctival Staining Score

Time frame: at the time of the evaluation. Mean (Standard Error). Unit: units on a scale

Measure	Diabetics n = 38	Non Diabetics n = 25
Value	2.72 (0.16)	2.19 (0.19)

Population analysed: There were 38 consecutive diabetics over 40 years of age and 25 consecutive non-diabetics over 40 years of age that qualified and agreed to enroll. A target of 25 non-diabetics was met. The target of 50 was not met as the study was stopped when the PI changed practices. By that time, 38 diabetics enrolled.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Diabetics	0 of 38 (0%)	0 of 38 (0%)	Not reported
Non Diabetics	0 of 25 (0%)	0 of 25 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Dry Eyes

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RecruitingPhase 1
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Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
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RecruitingPhase 1/2
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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.

Kenneth A Beckman, MD principal investigator

COA Research Foundation

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

Questions about this trial

What is this clinical trial studying?

An observational study of Dry Eyes, run by COA Research Foundation, INC at 1 site in United States.

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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 30 Sep 2013. 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 United States. 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?

Yes. Results are posted in the registry (first posted 30 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Conjunctival Staining Score (time frame: at the time of the evaluation). 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 NCT01450787.

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 30 Sep 2013.