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

A Randomized 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

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).

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Drug: Blink® Tears Lubricant Eye Drops; Drug: No topical artificial tear

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85260
      • Schwartz Laser Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BLINK™ tears	Drug: Blink® Tears Lubricant Eye Drops; Blink® Tears Lubricant Eye Drops
No Intervention: No topical artificial tear	Drug: No topical artificial tear; 40 patients randomized to not using a topical artificial tear.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate the safety and efficacy of BLINK™ tears	3 months

Collaborators and Investigators

• Sponsor: Innovative Medical
• Investigators: Principal Investigator: Marc Bloomenstein, M.D., Schwartz Laser Eye Center

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: February 1, 2010
• First Submitted That Met QC Criteria: February 2, 2010
• First Posted (Estimate): February 3, 2010

Study Record Updates

• Last Update Posted (Estimate): February 17, 2012
• Last Update Submitted That Met QC Criteria: February 15, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Relief of dry eye symptoms following implantation of TMF IOL
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic Solutions; Lubricant Eye Drops
• Other Study ID Numbers: TMF-001