Patient Satisfaction and Tear Osmolarity With the Use of Blink Tears, Blink Gel Tears and Systane Balance



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:May 2012
End Date:October 2012
Contact:eric D Donnenfeld, M.D.
Email:eddoph@aol.com
Phone:203-366-8000

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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).

Patient satisfaction and tear osmolarity with the use of Blink Tears, Blink Gel Tears and
Systane Balance.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

- 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)
We found this trial at
1
site
Fairfield, Connecticut 06824
1328
mi
from
Fairfield, CT
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