Dry EyeNCT01589640
Patient Satisfaction and Tear Osmolarity With the Use of Blink Tears, Blink Gel Tears and Systane Balance
An observational study of Dry Eye, run by Ophthalmic Consultants of Connecticut at 1 site in United States.
Trial summary
This is a single center clinical study designed to determine patient satisfaction and the effect of the use of artificial tears on tear osmolarity with time after instillation of three commercially available artifical tear eye solutions ( Blink Tears, Blink Gel Tears and Systane Balance). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Blink Tears lubricating Eye Drops, Blink Gel Tears Lubricating Eye Drops and Systane Balance Lubricant Eye Drop
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Oct 2012
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: greater then age 18
Who may be able to join
- male or femal subjects (aged 18 or older)
- diagnosed with mild to moderate dry eye syndrome
- provide written informed consent and sign/date a health information release
- women of childbreaing potential must be willing to practice effective contraception for the duration of the study.
Who cannot join
- have any active ocular disease other than mild to moderate dry eye sundrome that would interfere with study interpretation
- active ocular allergy in any eye
- history of or active ocular infection/inflammation
- concomitant use of contact lenses (unilateral or bilateral)
- history of any corneal refractive laser surgery (e.g., LASIK, LASEK, RK,PRK) in the study eye (s);
- corneal disorder or abnormality that affects cornea sensitivity or normal spreading of the tear film in any eye.
Show all 18Show fewer
- history of any intaocular surgery or glaucoma laser surgery (e.g., ALT, SLT) in the study eye (s)
- known sensitivity or allergy to any of the study medications or their components;
- uncontrolled systemic disease;
- contraindication to pupil dilation;
- Schirmer's Test- Standard Test (with anesthesia) result of less than or equal to 3 MM
- use of artifical tears prior to Baseline Visit (Visit 2, Day 0);
- Current use, use within 2 weeks prior to Baseline Visit ( Visit 2,Day 0) or likely use during the study period of any topical ophthalmic medications (e.g., antibotics, glaucoma medications) other than ophthalmic medications used in the study.
- use of any omega 3 supplement, artificial tear product (s), vasoconstrictor and/or redness reliever ocular drops 30 days prior to or during the study perior;
- use of cyclosporine ocular drops 12 months prior to or will require ocular surgery during the study period.
- females who are pregnany, nursing or planning a pregnancy or who are of childbearing potenital and not using a reliable method of contraception;
- any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results; and
- concurrent participation or prior participation in any investigational drug or device study within the last 30 days prior to the Screening Visit (Visit 1)
Trial locations and contacts
1 site in 1 country.
United States1 site
Ophthalmic Consultants of Connecticut
Fairfield, Connecticut, 06824
About this study
Official title: Phase 4 Study Accessing Patient Satisfaction and Tear Osmolarity While Using Blink Tears, Blink Gel Tears and Systane Balance
This is a single center clinical study designed to determine patient satisfaction and the effect of the use of artificial tears on tear osmolarity with time after instillation of three commercially available artifical tear eye solutions ( Blink Tears, Blink Gel Tears and Systane Balance).
Read the detailed description
Patient satisfaction and tear osmolarity with the use of Blink Tears, Blink Gel Tears and Systane Balance.
- Conditions
- Dry Eye
- Being tested
- Blink Tears lubricating Eye Drops, Blink Gel Tears Lubricating Eye Drops, Systane Balance Lubricant Eye Drop
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blink Tears lubricating Eye DropsOther
Also called Blink Tears
2 drops per eye drosed four times per day (8:00 Am, 12:00 PM, 4:00 PM and 8:00 PM)
Blink Gel Tears Lubricating Eye DropsOther
Also called Blink Gel Tears
2 drops per eye dosed four times per day (8:00 AM, 12:00PM, 4:00 PM and 8:00 PM)
Systane Balance Lubricant Eye DropOther
Also called Systane Balance
2 Drops per eye dosed four times per day ( 8:00 AM, 12:00 PM, 4:00 PM and 8:00PM)
| Study group | Role | What they receive |
|---|---|---|
| Blink Tears | Blink Tears is an over the counter artificial tear Receives: Other: Blink Tears lubricating Eye Drops | |
| Blink Gel Tears | Blink Gel Tears is an over the counter artifical tear product Receives: Other: Blink Gel Tears Lubricating Eye Drops | |
| Systane Balance | Systane Balance is an over the counter artificial Tear product Receives: Other: Systane Balance Lubricant Eye Drop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy variable is tear osmolarity
Measured: 28 days
Secondary outcomes (1)
Secondary efficacy variable is the Patient Symptom Questionnaire
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2012 (estimated)
- Study startMay 2012
- Primary completionSep 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ophthalmic Consultants of Connecticut
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Donnenfeld, M.D., Principal investigator, Ophthalmic Consultants of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01589640
- Sponsor's protocol ID
- EDD-BLNK-12-001
- Status last verified
- Apr 2012
- First submitted
- 30 Apr 2012
- Last updated
- 2 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study Accessing Patient Satisfaction and Tear Osmolarity While Using Blink Tears, Blink Gel Tears and Systane Balance
- ClinicalTrials.gov ID
- NCT01589640
- Acronym / sponsor ID
- EDD-BLNK-12-001
- Conditions
- Dry Eye
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ophthalmic Consultants of ConnecticutUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 2 May 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.
This is a single center clinical study designed to determine patient satisfaction and the effect of the use of artificial tears on tear osmolarity with time after instillation of three commercially available artifical tear eye solutions ( Blink Tears, Blink Gel Tears and Systane Balance).
Detailed description
Patient satisfaction and tear osmolarity with the use of Blink Tears, Blink Gel Tears and Systane Balance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Blink Tears | – | Other: Blink Tears lubricating Eye DropsBlink Tears is an over the counter artificial tear |
| Blink Gel Tears | – | Other: Blink Gel Tears Lubricating Eye DropsBlink Gel Tears is an over the counter artifical tear product |
| Systane Balance | – | Other: Systane Balance Lubricant Eye DropSystane Balance is an over the counter artificial Tear product |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- greater then age 18
Key inclusion criteria (4 listed)
- male or femal subjects (aged 18 or older)
- diagnosed with mild to moderate dry eye syndrome
- provide written informed consent and sign/date a health information release
- women of childbreaing potential must be willing to practice effective contraception for the duration of the study.
Key exclusion criteria (18 listed)
- have any active ocular disease other than mild to moderate dry eye sundrome that would interfere with study interpretation
- active ocular allergy in any eye
- history of or active ocular infection/inflammation
- concomitant use of contact lenses (unilateral or bilateral)
- history of any corneal refractive laser surgery (e.g., LASIK, LASEK, RK,PRK) in the study eye (s);
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 |
|---|---|---|
| Blink Tears lubricating Eye DropsAlso: Blink Tears2 drops per eye drosed four times per day (8:00 Am, 12:00 PM, 4:00 PM and 8:00 PM) | Other | Blink Tears |
| Blink Gel Tears Lubricating Eye DropsAlso: Blink Gel Tears2 drops per eye dosed four times per day (8:00 AM, 12:00PM, 4:00 PM and 8:00 PM) | Other | Blink Gel Tears |
| Systane Balance Lubricant Eye DropAlso: Systane Balance2 Drops per eye dosed four times per day ( 8:00 AM, 12:00 PM, 4:00 PM and 8:00PM) | Other | Systane Balance |
Primary outcome
Primary efficacy variable is tear osmolarity
Time frame: 28 days
1 secondary outcome
Secondary efficacy variable is the Patient Symptom Questionnaire
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2012.
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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.
Eric Donnenfeld, M.D. principal investigator
Ophthalmic Consultants of Connecticut
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 Eye, run by Ophthalmic Consultants of Connecticut 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 4 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 2 May 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact eric D Donnenfeld, M.D. (203-366-8000, eddoph@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary efficacy variable is tear osmolarity (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 May 2012.