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

Sponsor

Innovative Medical (Industry)

Overall Status

Completed

CT.gov ID

NCT01061268

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Drug: No topical artificial tear Drug: Blink® Tears Lubricant Eye Drops	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Feb 1, 2012

Actual Study Completion Date :

Feb 1, 2012

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

To evaluate the safety and efficacy of BLINK™ tears [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Schwartz Laser Eye Center	Scottsdale	Arizona	United States	85260

Sponsors and Collaborators

Innovative Medical

Investigators

Principal Investigator: Marc Bloomenstein, M.D., Schwartz Laser Eye Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Innovative Medical

ClinicalTrials.gov Identifier:

NCT01061268

Other Study ID Numbers:

TMF-001

First Posted:

Feb 3, 2010

Last Update Posted:

Feb 17, 2012

Last Verified:

Feb 1, 2012

Keywords provided by Innovative Medical

Relief of dry eye symptoms following implantation of TMF IOL

Additional relevant MeSH terms:

Dry Eye Syndromes

Keratoconjunctivitis Sicca

Ophthalmic Solutions

Lubricant Eye Drops

Study Results

No Results Posted as of Feb 17, 2012