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CompletedNCT01061268Updated Feb 17, 2012

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 Phase 4 interventional study of No topical artificial tear and Blink® Tears Lubricant Eye Drops in Dry Eye, sponsored by Innovative Medical. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2012-02-17.

Sponsored by Innovative Medical · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Dry Eye

Keywords

  • Relief of dry eye symptoms following implantation of TMF IOL
03

In context

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.

This study's enrollment of 25 is below the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Innovative Medical is the lead sponsor of 50 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    BLINK™ tears

    Drug: Blink® Tears Lubricant Eye Drops

  • No intervention
    No topical artificial tear

    Drug: No topical artificial tear

Interventions

  • DrugNo topical artificial tear

    40 patients randomized to not using a topical artificial tear.

  • DrugBlink® Tears Lubricant Eye Drops

    Blink® Tears Lubricant Eye Drops

06

What researchers measure

Primary outcomes

  1. To evaluate the safety and efficacy of BLINK™ tears

    Time frame: 3 months

07

Study locations

1 site
  • Schwartz Laser Eye Center
    Scottsdale, Arizona 85260, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01061268
Lead sponsor
Innovative Medical
Responsible party
Sponsor
First posted
Feb 3, 2010
Start date
Jan 2010
Primary completion
Feb 2012
Completion
Feb 2012
Last update
Feb 17, 2012

Study contacts

Marc Bloomenstein, M.D.
principal investigator · Schwartz Laser Eye Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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