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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Ophthalmic Consultants of Connecticut.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Ophthalmic Consultants of Connecticut
ClinicalTrials.gov Identifier:
NCT01589640
First received: April 30, 2012
Last updated: May 1, 2012
Last verified: April 2012

April 30, 2012
May 1, 2012
May 2012
September 2012   (final data collection date for primary outcome measure)
Primary efficacy variable is tear osmolarity [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01589640 on ClinicalTrials.gov Archive Site
Secondary efficacy variable is the Patient Symptom Questionnaire [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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).

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

greater then age 18

Dry Eye
  • 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 Name: Blink Tears
  • 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 Name: Blink Gel Tears
  • 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 Name: Systane Balance
  • Blink Tears
    Blink Tears is an over the counter artificial tear
    Intervention: Other: Blink Tears lubricating Eye Drops
  • Blink Gel Tears
    Blink Gel Tears is an over the counter artifical tear product
    Intervention: Other: Blink Gel Tears Lubricating Eye Drops
  • Systane Balance
    Systane Balance is an over the counter artificial Tear product
    Intervention: Other: Systane Balance Lubricant Eye Drop
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
60
October 2012
September 2012   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
Yes
Contact: eric D Donnenfeld, M.D. 203-366-8000 eddoph@aol.com
Contact: denise lavin 203-366-8000 dlavin@occeye.com
United States
 
NCT01589640
EDD-BLNK-12-001
No
Ophthalmic Consultants of Connecticut
Ophthalmic Consultants of Connecticut
Not Provided
Principal Investigator: Eric Donnenfeld, M.D. Ophthalmic Consultants of Connecticut
Ophthalmic Consultants of Connecticut
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP