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
1 other identifier
observational
60
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2012
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedFirst Posted
Study publicly available on registry
May 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedMay 2, 2012
April 1, 2012
4 months
April 30, 2012
May 1, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Primary efficacy variable is tear osmolarity
28 days
Secondary Outcomes (1)
Secondary efficacy variable is the Patient Symptom Questionnaire
28 days
Study Arms (3)
Blink Tears
Blink Tears is an over the counter artificial tear
Blink Gel Tears
Blink Gel Tears is an over the counter artifical tear product
Systane Balance
Systane Balance is an over the counter artificial Tear product
Interventions
2 drops per eye drosed four times per day (8:00 Am, 12:00 PM, 4:00 PM and 8:00 PM)
2 drops per eye dosed four times per day (8:00 AM, 12:00PM, 4:00 PM and 8:00 PM)
2 Drops per eye dosed four times per day ( 8:00 AM, 12:00 PM, 4:00 PM and 8:00PM)
Eligibility Criteria
greater then age 18
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ophthalmic Consultants of Connecticut
Fairfield, Connecticut, 06824, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Donnenfeld, M.D.
Ophthalmic Consultants of Connecticut
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2012
First Posted
May 2, 2012
Study Start
May 1, 2012
Primary Completion
September 1, 2012
Study Completion
October 1, 2012
Last Updated
May 2, 2012
Record last verified: 2012-04