Dry Eye
Conditions
Brief 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).
Detailed description
Patient satisfaction and tear osmolarity with the use of Blink Tears, Blink Gel Tears and Systane Balance.
Interventions
OTHERBlink Tears lubricating Eye Drops
2 drops per eye drosed four times per day (8:00 Am, 12:00 PM, 4:00 PM and 8:00 PM)
OTHERBlink Gel Tears Lubricating Eye Drops
2 drops per eye dosed four times per day (8:00 AM, 12:00PM, 4:00 PM and 8:00 PM)
OTHERSystane Balance Lubricant Eye Drop
2 Drops per eye dosed four times per day ( 8:00 AM, 12:00 PM, 4:00 PM and 8:00PM)
Sponsors
Ophthalmic Consultants of Connecticut
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy variable is tear osmolarity | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy variable is the Patient Symptom Questionnaire | 28 days |
Countries
United States
Contacts
Primary Contacteric D Donnenfeld, M.D.
Backup Contactdenise lavin
Outcome results
None listed