GlaucomaPhase 4IVESNCT01682460

Pilot Study on the Use of Artificial Tears to Treat Dry Eye in Glaucoma Patients

A Phase 4 study testing Refresh Tears Lubricant Eye Drops (Allergan) in people with Glaucoma and Dry Eyes, run by University of Waterloo at 1 site in Canada.

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

Who is it for?: Ages 17 years and older
Conditions the study is for: Glaucoma, Dry Eyes
What is being tested?: Refresh Tears Lubricant Eye Drops (Allergan)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteCanada
Study dates: Aug 2012to Apr 2013
Phase: Phase 4
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 17 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

At least 17 years of age and has full legal capacity to volunteer;
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Is a current non-contact lens wearer.
Has previously been diagnosed with primary open angle glaucoma and is currently being treated with a topical therapeutic agent.
The glaucoma medication dosage and usage must have been the same for >6 months.
Shows a minimum score of 2 (sometimes) on the SESOD questionnaire.
Distance VA of at least 20/40 in each eye with current spectacle correction.

Who cannot join

Is participating in any concurrent clinical or research study;
Has any known active* ocular disease and/or infection; except primary open angle glaucoma.
Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
Is using any systemic or topical medications (with the exception of glaucoma medication) that in the opinion of the investigator may affect a study outcome variable;
Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
Is pregnant, lactating or planning a pregnancy at the time of enrolment;

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Has undergone refractive error surgery;
Is an employee of the Centre for Contact Lens Research;
Has taken part in another (pharmaceutical) research study within the last 30 days;
Is currently using artificial tears more than 3 times per day.
For the purposes of this study, active ocular disease is defined as infection or inflammation that requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Centre for Contact Lens Research, University of Waterloo
Waterloo, Ontario, N2L 3G1

Other trials in Canada

About this study

Research indicates that many people who are being treated for glaucoma have dry eyes. The purpose of this study is to test the use of artificial tears to alleviate dryness signs and symptoms in people who are using medication to treat glaucoma. The study hypothesis is that the use of artificial tears will result in an improvement in clinical signs and symptoms associated with dry eyes.

Conditions: Glaucoma, Dry Eyes
Being tested: Refresh Tears Lubricant Eye Drops (Allergan)
Medical subject headings: Glaucoma, Dry Eye Syndromes

What participants receive

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

Refresh Tears Lubricant Eye Drops (Allergan)Drug
Eye drops QID for 1 month

Study groups in NCT01682460
Study group	Role	What they receive
Refresh Tears Lubricant Eye Drops (Allergan)	Experimental	Artificial tears eye drops QID for 1 month Receives: Drug: Refresh Tears Lubricant Eye Drops (Allergan)

What is being measured

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

Ocular Surface Staining
Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence
Measured: At baseline (dispensing visit)
Ocular Surface Staining
Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence
Measured: After 1 week
Ocular Surface Staining
Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence
Measured: After 1 month
Tear Break up Time With Fluorescein
The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .
Measured: At baseline (dispensing visit)
Tear Break up Time With Fluorescein
The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .
Measured: After 1 week
Tear Break up Time With Fluorescein
The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .
Measured: After 1 month

Secondary outcomes (3)

Ocular Surface Disease Index (OSDI) Score
The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worst possible score).
Measured: At baseline (dispensing visit)
Ocular Surface Disease Index (OSDI) Score
The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worst possible score).
Measured: 1 week after using artificial tears
Ocular Surface Disease Index (OSDI) Score
The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worse possible score).
Measured: 1 month after using artificial tears

Timeline

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

Aug 2012Apr 2013

First posted11 Sep 2012 (estimated)
Study startAug 2012
Primary completionApr 2013
Study completionApr 2013

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 GlaucomaStudies 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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01682460
Sponsor's protocol ID: 18262
Acronym: IVES
Status last verified: May 2017
First submitted: 29 Aug 2012
Last updated: 5 Jun 2017
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 Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study on the Use of Artificial Tears to Treat Dry Eye in Glaucoma Patients
ClinicalTrials.gov ID: NCT01682460
Acronym / sponsor ID: IVES / 18262
Conditions: Glaucoma, Dry Eyes
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: University of WaterlooUniversity, hospital or other
Collaborators: Allergan
Study start: Aug 2012
Primary completion: Apr 2013 (actual)
Study completion: Apr 2013 (actual)
First posted: 11 Sep 2012 (estimated)
Results: Posted 3 Jul 2014

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Refresh Tears Lubricant Eye Drops (Allergan)	Experimental	Drug: Refresh Tears Lubricant Eye Drops (Allergan)Artificial tears eye drops QID for 1 month

Who may qualify

Ages: 17 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (8 listed)

At least 17 years of age and has full legal capacity to volunteer;
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Is a current non-contact lens wearer.
Has previously been diagnosed with primary open angle glaucoma and is currently being treated with a topical therapeutic agent.

Key exclusion criteria (11 listed)

Is participating in any concurrent clinical or research study;
Has any known active* ocular disease and/or infection; except primary open angle glaucoma.
Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
Is using any systemic or topical medications (with the exception of glaucoma medication) that in the opinion of the investigator may affect a study outcome variable;
Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;

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
Refresh Tears Lubricant Eye Drops (Allergan)Eye drops QID for 1 month	Drug	Refresh Tears Lubricant Eye Drops (Allergan)

Primary outcome

Ocular Surface Staining
Time frame: At baseline (dispensing visit)
Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence
Ocular Surface Staining
Time frame: After 1 week
Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence
Ocular Surface Staining
Time frame: After 1 month
Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence
Tear Break up Time With Fluorescein
Time frame: At baseline (dispensing visit)
The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .
Tear Break up Time With Fluorescein
Time frame: After 1 week
The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .
Tear Break up Time With Fluorescein
Time frame: After 1 month
The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .

3 secondary outcomes

Ocular Surface Disease Index (OSDI) Score
Time frame: At baseline (dispensing visit)
Ocular Surface Disease Index (OSDI) Score
Time frame: 1 week after using artificial tears
Ocular Surface Disease Index (OSDI) Score
Time frame: 1 month after using artificial tears

Results and safety

Results posted to the registry on 3 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Refresh Tears Lubricant Eye Drops (Allergan)	15	11

Primary outcome: Ocular Surface Staining

Time frame: At baseline (dispensing visit). Mean (Standard Deviation). Unit: units on a scale

Measure	Refresh Tears Lubricant Eye Drops (Allergan) n = 11
Value	1.65 (0.80)

Primary outcome: Ocular Surface Staining

Time frame: After 1 week. Mean (Standard Deviation). Unit: units on a scale

Measure	Refresh Tears Lubricant Eye Drops (Allergan) n = 11
Value	1.55 (0.88)

Primary outcome: Ocular Surface Staining

Time frame: After 1 month. Mean (Standard Deviation). Unit: units on a scale

Measure	Refresh Tears Lubricant Eye Drops (Allergan) n = 11
Value	1.29 (0.89)

Primary outcome: Tear Break up Time With Fluorescein

Time frame: At baseline (dispensing visit). Mean (Standard Deviation). Unit: seconds

Measure	Refresh Tears Lubricant Eye Drops (Allergan) n = 11
Value	2.88 (2.01)

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Refresh Tears Lubricant Eye Drops (Allergan)	0 of 11 (0%)	1 of 11 (9.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Lyndon Jones, PhD principal investigator

University of Waterloo

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Refresh Tears Lubricant Eye Drops (Allergan) in people with Glaucoma and Dry Eyes, run by University of Waterloo at 1 site in Canada.

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 8 inclusion and 11 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 5 Jun 2017. 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 Canada. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jul 2014). 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?

Ocular Surface Staining (time frame: At baseline (dispensing visit)). The study lists 6 primary outcomes in all. 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 NCT01682460.

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 5 Jun 2017.