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

Dry Eye Clinical Trial

Official title:

Phase 4 Study Accessing Patient Satisfaction and Tear Osmolarity While Using Blink Tears, Blink Gel Tears and Systane Balance

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01589640
• Other study ID #: EDD-BLNK-12-001
• Status: Not yet recruiting
• Phase: Phase 4
• First received: April 30, 2012
• Last updated: May 1, 2012
• Start date: May 2012
• Est. completion date: October 2012

Study information

• Verified date: April 2012
• Source: Ophthalmic Consultants of Connecticut
• Contact: eric D Donnenfeld, M.D.
• Phone: 203-366-8000
• Email: eddoph[@]aol.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dry Eye

Intervention

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)
• 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)
• 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)

Locations

Country	Name	City	State
United States	Ophthalmic Consultants of Connecticut	Fairfield	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Ophthalmic Consultants of Connecticut

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary efficacy variable is tear osmolarity		28 days	No
Secondary	Secondary efficacy variable is the Patient Symptom Questionnaire		28 days	No