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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Innovative Medical
ClinicalTrials.gov Identifier:
NCT01061268
First received: February 1, 2010
Last updated: February 15, 2012
Last verified: February 2012

February 1, 2010
February 15, 2012
January 2010
February 2012   (final data collection date for primary outcome measure)
To evaluate the safety and efficacy of BLINK™ tears [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01061268 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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 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

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).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Dry Eye
  • Drug: No topical artificial tear
    40 patients randomized to not using a topical artificial tear.
  • Drug: Blink® Tears Lubricant Eye Drops
    Blink® Tears Lubricant Eye Drops
  • Experimental: BLINK™ tears
    Intervention: Drug: Blink® Tears Lubricant Eye Drops
  • No Intervention: No topical artificial tear
    Intervention: Drug: No topical artificial tear
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
February 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01061268
TMF-001
No
Innovative Medical
Innovative Medical
Not Provided
Principal Investigator: Marc Bloomenstein, M.D. Schwartz Laser Eye Center
Innovative Medical
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP