NCT01061268

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 1, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

February 17, 2012

Status Verified

February 1, 2012

Enrollment Period

2.1 years

First QC Date

February 1, 2010

Last Update Submit

February 15, 2012

Conditions

Dry Eye

Keywords

Relief of dry eye symptoms following implantation of TMF IOL

Outcome Measures

Primary Outcomes (1)

  • To evaluate the safety and efficacy of BLINK™ tears

    3 months

Study Arms (2)

BLINK™ tears

EXPERIMENTAL
Drug: Blink® Tears Lubricant Eye Drops

No topical artificial tear

NO INTERVENTION
Drug: No topical artificial tear

Interventions

No topical artificial tearDRUG

40 patients randomized to not using a topical artificial tear.

No topical artificial tear
Blink® Tears Lubricant Eye DropsDRUG

Blink® Tears Lubricant Eye Drops

BLINK™ tears

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schwartz Laser Eye Center

Scottsdale, Arizona, 85260, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Marc Bloomenstein, M.D.

    Schwartz Laser Eye Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2010

First Posted

February 3, 2010

Study Start

January 1, 2010

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

February 17, 2012

Record last verified: 2012-02

Locations

US(1)