Clinical trial NCT01589640: Patient Satisfaction and Tear Osmolarity With the Use of Blink Tears, Blink Gel Tears and Systane Balance
Official title: Phase 4 Study Accessing Patient Satisfaction and Tear Osmolarity While Using Blink Tears, Blink Gel Tears and Systane Balance
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dry Eye
Lead sponsor: Ophthalmic Consultants of Connecticut
Sponsor class: OTHER
First posted: 2012-05-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: greater then age 18

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Primary efficacy variable is tear osmolarity
timeFrame: 28 days
Secondary outcomes:
measure: Secondary efficacy variable is the Patient Symptom Questionnaire
timeFrame: 28 days
Other outcomes:
Locations:
city: Fairfield
country: United States
facility: Ophthalmic Consultants of Connecticut
state: Connecticut
Study officials:
affiliation: Ophthalmic Consultants of Connecticut
name: Eric Donnenfeld, M.D.
role: PRINCIPAL_INVESTIGATOR
References: