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

NCT ID: NCT01061268

Last Updated: 2012-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2012-02-29

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).

Conditions

Dry Eye

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BLINK™ tears

Group Type: EXPERIMENTAL

Blink® Tears Lubricant Eye Drops

Intervention Type: DRUG

Blink® Tears Lubricant Eye Drops

No topical artificial tear

Group Type: NO_INTERVENTION

No topical artificial tear

Intervention Type: DRUG

40 patients randomized to not using a topical artificial tear.

Interventions

No topical artificial tear

40 patients randomized to not using a topical artificial tear.

Intervention Type: DRUG

Blink® Tears Lubricant Eye Drops

Blink® Tears Lubricant Eye Drops

Intervention Type: DRUG

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovative Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Bloomenstein, M.D.

Role: PRINCIPAL_INVESTIGATOR

Schwartz Laser Eye Center

Locations

Schwartz Laser Eye Center

Scottsdale, Arizona, United States

Countries

United States

Other Identifiers

TMF-001

Identifier Type: -

Identifier Source: org_study_id