a clinical evaluation pilot study of the efficacy of blink® tears lubricant eye drops for the relief of dry eye symptoms following implantation of tecnis® multifocal introcular lens

Conditions: Dry Eye

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).


Eligibility criteria:
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

Keywords: relief of dry eye symptoms following implantation of tmf iol