NCT01589640
Unknown
Not Applicable
Phase 4 Study Accessing Patient Satisfaction and Tear Osmolarity While Using Blink Tears, Blink Gel Tears and Systane Balance
Ophthalmic Consultants of Connecticut1 site in 1 country60 target enrollmentMay 2012
ConditionsDry Eye
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dry Eye
- Sponsor
- Ophthalmic Consultants of Connecticut
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Primary efficacy variable is tear osmolarity
- Last Updated
- 14 years ago
Overview
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.
Investigators
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;
Outcomes
Primary Outcomes
Primary efficacy variable is tear osmolarity
Time Frame: 28 days
Secondary Outcomes
- Secondary efficacy variable is the Patient Symptom Questionnaire(28 days)
Study Sites (1)
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