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

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01061268
• Other study ID #: TMF-001
• Status: Completed
• Phase: Phase 4
• First received: February 1, 2010
• Last updated: February 15, 2012
• Start date: January 2010
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: Innovative Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• No topical artificial tear
40 patients randomized to not using a topical artificial tear.
• Blink® Tears Lubricant Eye Drops
Blink® Tears Lubricant Eye Drops

Locations

Country	Name	City	State
United States	Schwartz Laser Eye Center	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Innovative Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and efficacy of BLINK™ tears		3 months	Yes