Dry Eye
Conditions
Keywords
Relief of dry eye symptoms following implantation of TMF IOL
Brief summary
To evaluate the safety and efficacy of BLINK™ tears compared with NO topical artificial tear use in improving subject's visual performance and reduce ocular symptoms of discomfort in subjects who have undergone cataract surgery implanted with a Tecnis™ diffractive multifocal intraocular lens (IOL).
Interventions
DRUGNo topical artificial tear
40 patients randomized to not using a topical artificial tear.
DRUGBlink® Tears Lubricant Eye Drops
Blink® Tears Lubricant Eye Drops
Sponsors
Innovative Medical
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female subjects, 21 years of age or older * Written, informed consent and HIPPA Authorization * Has 20/40 or better best corrected visual acuity in the surgical eye at the Day 1 post-op visit (Visit 3) * Has undergone cataract surgery in only one eye and has received a Tecnis multi-focal intraocular lens in the study eye. * Patients not currently using any artificial tears regularly, or using low viscosity tears for symptom relief (Refresh Tears, Visine Tears, Tears Naturelle, etc.) * Likely to complete the entire course of the study.
Exclusion criteria
* Use of systemic or ocular medications that may affect vision * Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.) * Subjects with diabetes mellitus * Uncontrolled systemic or ocular disease * History of ocular trauma or prior ocular surgery * Amblyopia or strabismus * Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.) * Diagnosed degenerative visual disorders (e.g. macular degeneration, or other retinal disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse * Subjects who may be expected to require retinal laser treatment or other surgical intervention * Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome) * Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 4.0 mm under mesopic/scotopic conditions) * Contact lens usage within 6 months for PMMA contacts lenses, 1 month for gas permeable lenses or 1 week for extended-wear and daily-wear soft contact lenses * A subject whose best-corrected visual acuity is worse than 20/40 in their surgical eye * A subject with any UNCONTROLLED systemic disease. A potential subject in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study * A subject that required the use of any artificial tear supplements, vasoconstrictor and/or redness reliever ocular drops 28 days prior to or during the study period * A subject that required the use of cyclosporine ocular drops 3 months prior to or during the study period * A subject with active ocular inflammation or corneal edema beyond what is expected on Day 1 after cataract surgery in the study eye * A subject with a history of conjunctivitis or ocular infection in the study eye within the past 3 months, or a history of kerato-refractive surgery in the study eye within the past 6 months of entry in to the study * A subject that has punctual plug(s), intracanalicular plug(s) or a history of punctual cautery in the study eye
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and efficacy of BLINK™ tears | 3 months |
Countries
United States
Outcome results
None listed