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

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innovative Medical
• Treatments: Lubricant Eye Drops; Ophthalmic Solutions; Polystyrene sulfonic acid; Tetrahydrozoline

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