NCT01061268CompletedPhase 4
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Innovative Medical
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- To evaluate the safety and efficacy of BLINK™ tears
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- 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
- •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
Arms & Interventions
BLINK™ tears
Experimental
Intervention: Blink® Tears Lubricant Eye Drops (Drug)
No topical artificial tear
No Intervention
Intervention: No topical artificial tear (Drug)
Outcomes
Primary Outcomes
To evaluate the safety and efficacy of BLINK™ tears
Time Frame: 3 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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