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

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).

Study Overview

• Status: Unknown
• Conditions: Dry Eye
• Intervention / Treatment: Other: Blink Tears lubricating Eye Drops; Other: Blink Gel Tears Lubricating Eye Drops; Other: Systane Balance Lubricant Eye Drop

Detailed Description

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

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: eric D Donnenfeld, M.D.; Phone Number: 203-366-8000; Email: eddoph@aol.com
• Study Contact Backup: Name: denise lavin; Phone Number: 203-366-8000; Email: dlavin@occeye.com

Study Locations

• United States
  • Connecticut
    • Fairfield, Connecticut, United States, 06824
      • Ophthalmic Consultants of Connecticut

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

greater then age 18

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Blink Tears; Blink Tears is an over the counter artificial tear	Other: Blink 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); Other Names: Blink Tears
Blink Gel Tears; Blink Gel Tears is an over the counter artifical tear product	Other: Blink 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); Other Names: Blink Gel Tears
Systane Balance; Systane Balance is an over the counter artificial Tear product	Other: Systane 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); Other Names: Systane Balance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Primary efficacy variable is tear osmolarity	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Secondary efficacy variable is the Patient Symptom Questionnaire	28 days

Collaborators and Investigators

• Sponsor: Ophthalmic Consultants of Connecticut
• Investigators: Principal Investigator: Eric Donnenfeld, M.D., Ophthalmic Consultants of Connecticut

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Anticipated): September 1, 2012
• Study Completion (Anticipated): October 1, 2012

Study Registration Dates

• First Submitted: April 30, 2012
• First Submitted That Met QC Criteria: May 1, 2012
• First Posted (Estimate): May 2, 2012

Study Record Updates

• Last Update Posted (Estimate): May 2, 2012
• Last Update Submitted That Met QC Criteria: May 1, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes; Pharmaceutical Solutions; Ophthalmic Solutions; Lubricant Eye Drops
• Other Study ID Numbers: EDD-BLNK-12-001