Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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).


Condition Intervention Phase
Dry Eye
Other: Blink Tears lubricating Eye Drops
Other: Blink Gel Tears Lubricating Eye Drops
Other: Systane Balance Lubricant Eye Drop
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase 4 Study Accessing Patient Satisfaction and Tear Osmolarity While Using Blink Tears, Blink Gel Tears and Systane Balance

Resource links provided by NLM:


Further study details as provided by Ophthalmic Consultants of Connecticut:

Primary Outcome Measures:
  • Primary efficacy variable is tear osmolarity [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary efficacy variable is the Patient Symptom Questionnaire [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2012
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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 Name: 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 Name: Systane Balance

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

greater then age 18

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01589640

Contacts
Contact: eric D Donnenfeld, M.D. 203-366-8000 eddoph@aol.com
Contact: denise lavin 203-366-8000 dlavin@occeye.com

Locations
United States, Connecticut
Ophthalmic Consultants of Connecticut Not yet recruiting
Fairfield, Connecticut, United States, 06824
Sponsors and Collaborators
Ophthalmic Consultants of Connecticut
Investigators
Principal Investigator: Eric Donnenfeld, M.D. Ophthalmic Consultants of Connecticut
  More Information

No publications provided

Responsible Party: Ophthalmic Consultants of Connecticut
ClinicalTrials.gov Identifier: NCT01589640     History of Changes
Other Study ID Numbers: EDD-BLNK-12-001
Study First Received: April 30, 2012
Last Updated: May 1, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Ophthalmic Solutions
Tetrahydrozoline
Autonomic Agents
Cardiovascular Agents
Nasal Decongestants
Peripheral Nervous System Agents
Pharmaceutical Solutions
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sympathomimetics
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on November 24, 2014