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

NCT ID: NCT01589640

Last Updated: 2012-05-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2012-10-31

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.

Conditions

Dry Eye

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Blink Tears

Blink Tears is an over the counter artificial tear

Blink Tears lubricating Eye Drops

Intervention Type: OTHER

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

Blink Gel Tears is an over the counter artifical tear product

Blink Gel Tears Lubricating Eye Drops

Intervention Type: OTHER

2 drops per eye dosed four times per day (8:00 AM, 12:00PM, 4:00 PM and 8:00 PM)

Systane Balance

Systane Balance is an over the counter artificial Tear product

Systane Balance Lubricant Eye Drop

Intervention Type: OTHER

2 Drops per eye dosed four times per day ( 8:00 AM, 12:00 PM, 4:00 PM and 8:00PM)

Interventions

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)

Intervention Type: 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)

Intervention Type: 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)

Intervention Type: OTHER

Other Intervention Names

Blink Tears; Blink Gel Tears; 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ophthalmic Consultants of Connecticut

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Donnenfeld, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ophthalmic Consultants of Connecticut

Locations

Ophthalmic Consultants of Connecticut

Fairfield, Connecticut, United States

Countries

United States

Central Contacts

eric D Donnenfeld, M.D.

Role: CONTACT

eddoph@aol.com

203-366-8000

denise lavin

Role: CONTACT

dlavin@occeye.com

203-366-8000

Other Identifiers

EDD-BLNK-12-001

Identifier Type: -

Identifier Source: org_study_id