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
  Purpose

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 Intervention Phase
Dry Eye
Drug: No topical artificial tear
Drug: Blink® Tears Lubricant Eye Drops
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Innovative Medical:

Primary Outcome Measures:
  • To evaluate the safety and efficacy of BLINK™ tears [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: January 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01061268

Locations
United States, Arizona
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
  More Information

No publications provided

Responsible Party: Innovative Medical
ClinicalTrials.gov Identifier: NCT01061268     History of Changes
Other Study ID Numbers: TMF-001
Study First Received: February 1, 2010
Last Updated: February 15, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Innovative Medical:
Relief of dry eye symptoms following implantation of TMF IOL

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Tetrahydrozoline
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on August 28, 2014