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

Phase 4

Completed

• Conditions: Dry Eye
• Interventions: Drug: Blink® Tears Lubricant Eye Drops; Drug: No topical artificial tear

• Registration Number: NCT01061268
• Lead Sponsor: Innovative Medical

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-02-01
• Study First Submitted QC: 2010-02-02
• Study First Posted: 2010-02-03
• Status Verified: 2012-02
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Last Update Submitted: 2012-02-15
• Last Update Posted: 2012-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BLINK™ tears	Blink® Tears Lubricant Eye Drops	-
No topical artificial tear	No topical artificial tear	-

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and efficacy of BLINK™ tears	3 months

Trial Locations

Locations (1)

Schwartz Laser Eye Center; 🇺🇸 Scottsdale, Arizona, United States