Dry Eye SyndromeBENTLEYNCT02100787

Changes in Tear Osmolarity Over Time With Sustained Use of TheraTears

A study testing TheraTears lubricating drops in people with Dry Eye Syndrome, run by Jenkins Eye Care at 1 site in United States.

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

The objective of the study is to see if there is a change in tear osmolarity over time when moderate to severe dry eye subjects are treated with TheraTears® lubricating drops. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Dry Eye Syndrome
What is being tested?: TheraTears lubricating drops
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: 10 Apr 2014to 30 Jun 2016
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 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Is at least 21 years of age and has full legal capacity to volunteer;
Has read and signed the information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Is diagnosed with dry eye syndrome (in at least one eye), indicated by current ocular examination, prior history (self-reported history of dry eye is acceptable) and current use of treatments for dry eye;
Has a minimum osmolarity reading of 316 mosm/kg at the baseline visit in at least one eye.

Who cannot join

Has taken part in another research study within the last 30 days;
Planned contact lens wear during the course of the study;
Staff at the investigational site or family member of site staff or family member of currently enrolled participant;
Any subject that violates the washout period by using eye drops during the 72hrs washout period;
Has any known ocular disease including active ocular infection, inflammation or allergy, especially Salzmann's nodular degeneration, symptomatic conjunctivochalasis, and fixation disparity syndrome;
Used Restasis (or similar topical medication) within the last 6 months;

Show all 11Show fewer

Has a systemic condition that in the opinion of the investigator may affect the dry eye status of the subject, especially those newly diagnosed, newly prescribed and/or unstable;
Is pregnant, lactating or planning a pregnancy at the time of enrolment (verbal confirmation necessary);
Use of medications such as: Systemic Antihistamine (e.g., Allegra®, Benadryl®, Claritin®, Dimetapp®, Unisom®, Zyrtec®, etc.), Isotretinoin (e.g., Accutane®, Roaccutane®, Amnesteem®, Claravis®, Isotroin®, Sotret®) or similar medications;
Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
Has undergone ocular surgery(LASIK, Cataract, etc)within the last year.

Trial locations and contacts

1 site in 1 country.

United States1 site

Jenkins Eye Care
Honolulu, Hawaii, 96814

Other trials in United States

About this study

Official title: Evaluation of Tear Osmolarity Over Time With Sustained Use of TheraTears Lubricating Drops

The objective of the study is to see if there is a change in tear osmolarity over time when moderate to severe dry eye subjects are treated with TheraTears® lubricating drops.

Read the detailed description

The hypothesis is that the measured tear osmolarity from study participants decrease with sustained use of a over-the-counter artificial tears, TheraTears® lubricating drops, over an eight week period. Participant's dry eye symptoms would also improve with sustained use of TheraTears® lubricating drops.

Conditions: Dry Eye Syndrome
Being tested: TheraTears lubricating drops
Keywords: tear osmolarity, keratitis sicca, ocular surface disease, TheraTears
Medical subject headings: Dry Eye Syndromes, Keratitis sicca

What participants receive

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

TheraTears lubricating dropsOther
A over-the-counter lubricating eye drop to be used 1 drop in both eyes 4 times a day (QID) for 8 weeks

Study groups in NCT02100787
Study group	Role	What they receive
TheraTears lubricating drops	Experimental	TheraTears lubricating eye drops to be used 1 drop in both eyes four times a day (QID) Receives: Other: TheraTears lubricating drops

What is being measured

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

Change in tear osmolarity
Measured: Baseline and 8 weeks
Change in the Ocular Surface Disease Index (OSDI) score
The OSDI is a questionnaire that the subject completes to gauge their dry eye symptoms.
Measured: Baseline and 8 weeks

Secondary outcomes (4)

Change in visual acuity
Measured: Baseline and 8 weeks
Change in Tear Break Up Time
Measured: baseline and 8 weeks
Change in Phenol Red Thread test
Measured: baseline and 8 weeks
Change in corneal and conjunctival staining
Measured: baseline and 8 weeks

Timeline

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

10 Apr 201430 Jun 2016

First posted1 Apr 2014 (estimated)
Study start10 Apr 2014
Primary completion12 Apr 2016
Study completion30 Jun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02100787
Sponsor's protocol ID: AVR_PM_102_13
Acronym: BENTLEY
Status last verified: Feb 2017
First submitted: 27 Mar 2014
Last updated: 3 Mar 2017
Results posted: No
Data monitoring committee: No

Publications

Keech A, Senchyna M, Jones L. Impact of time between collection and collection method on human tear fluid osmolarity. Curr Eye Res. 2013 Apr;38(4):428-36. doi: 10.3109/02713683.2013.763987. Epub 2013 Feb 12.
PubMed 23402632
Chia EM, Mitchell P, Rochtchina E, Lee AJ, Maroun R, Wang JJ. Prevalence and associations of dry eye syndrome in an older population: the Blue Mountains Eye Study. Clin Exp Ophthalmol. 2003 Jun;31(3):229-32. doi: 10.1046/j.1442-9071.2003.00634.x.
PubMed 12786773

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?

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All Dry Eye Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Tear Osmolarity Over Time With Sustained Use of TheraTears Lubricating Drops
ClinicalTrials.gov ID: NCT02100787
Acronym / sponsor ID: BENTLEY / AVR_PM_102_13
Conditions: Dry Eye Syndrome
Keywords: tear osmolarity, keratitis sicca, ocular surface disease, TheraTears
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Jenkins Eye CareUniversity, hospital or other
Collaborators: Advanced Vision Research
Study start: 10 Apr 2014 (actual)
Primary completion: 12 Apr 2016 (actual)
Study completion: 30 Jun 2016 (actual)
First posted: 1 Apr 2014 (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.

The objective of the study is to see if there is a change in tear osmolarity over time when moderate to severe dry eye subjects are treated with TheraTears® lubricating drops.

Detailed description

Study design

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

Arm	Type	Receives
TheraTears lubricating drops	Experimental	Other: TheraTears lubricating dropsTheraTears lubricating eye drops to be used 1 drop in both eyes four times a day (QID)

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Is at least 21 years of age and has full legal capacity to volunteer;
Has read and signed the information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Is diagnosed with dry eye syndrome (in at least one eye), indicated by current ocular examination, prior history (self-reported history of dry eye is acceptable) and current use of treatments for dry eye;
Has a minimum osmolarity reading of 316 mosm/kg at the baseline visit in at least one eye.

Key exclusion criteria (11 listed)

Has taken part in another research study within the last 30 days;
Planned contact lens wear during the course of the study;
Staff at the investigational site or family member of site staff or family member of currently enrolled participant;
Any subject that violates the washout period by using eye drops during the 72hrs washout period;
Has any known ocular disease including active ocular infection, inflammation or allergy, especially Salzmann's nodular degeneration, symptomatic conjunctivochalasis, and fixation disparity syndrome;

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
TheraTears lubricating dropsA over-the-counter lubricating eye drop to be used 1 drop in both eyes 4 times a day (QID) for 8 weeks	Other	TheraTears lubricating drops

Primary outcome

Change in tear osmolarity
Time frame: Baseline and 8 weeks
Change in the Ocular Surface Disease Index (OSDI) score
Time frame: Baseline and 8 weeks
The OSDI is a questionnaire that the subject completes to gauge their dry eye symptoms.

4 secondary outcomes

Change in visual acuity
Time frame: Baseline and 8 weeks
Change in Tear Break Up Time
Time frame: baseline and 8 weeks
Change in Phenol Red Thread test
Time frame: baseline and 8 weeks
Change in corneal and conjunctival staining
Time frame: baseline and 8 weeks

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 Mar 2017.
Results publication: PubMed 23402632Keech A, Senchyna M, Jones L. Impact of time between collection and collection method on human tear fluid osmolarity. Curr Eye Res. 2013 Apr;38(4):428-36. doi: 10.3109/02713683.2013.763987. Epub 2013 Feb 12.
Results publication: PubMed 12786773Chia EM, Mitchell P, Rochtchina E, Lee AJ, Maroun R, Wang JJ. Prevalence and associations of dry eye syndrome in an older population: the Blue Mountains Eye Study. Clin Exp Ophthalmol. 2003 Jun;31(3):229-32. doi: 10.1046/j.1442-9071.2003.00634.x.

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Not yet recruitingPhase 2
Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments
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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.

Loretta Ng, OD principal investigator

Jenkins Eye Care

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

Questions about this trial

What is this clinical trial studying?

A study testing TheraTears lubricating drops in people with Dry Eye Syndrome, run by Jenkins Eye Care 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 5 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 3 Mar 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 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?

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?

Change in tear osmolarity (time frame: Baseline and 8 weeks). The study lists 2 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 NCT02100787, which also lists 2 linked publications.

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 Mar 2017.