Evaluation of Multifocal Contact Lens Designs With and Without an HEV Blocker on Visual Function
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Visual Acuity
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Starburst Diameter (mm)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a single-masked, bilateral, controlled, randomized, 2x2 crossover, non-dispensing clinical trial to characterize the effects of an HEV-Blocker on several measures of visual function in a presbyopic population.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- •Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form
- •Appear able and willing to adhere to the instructions set forth in this clinical protocol.
- •Be between at least 40 and not more than 70 years of age at the time of screening.
- •Possess a wearable pair of spectacles that provide correction for distance vision.
- •Be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month of more duration).
- •Be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".
- •The subject must have normal color perception as evidenced by reading 17 out of the first 21 Ishihara plates correctly.
- •The subject's distance spherical equivalent of their refraction must be in the range of -1.00 D to -4.00 D.
- •The subject's refractive cylinder must be ≤0.75 D in each eye.
Exclusion Criteria
- •Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- •Be currently pregnant or lactating.
- •Any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study.
- •Use of any of the following oral medications within 1 week prior to enrollment: oral retinoids, oral tetracyclines, oral phenothiazines, anticholinergics, oral/inhaled steroids, oral phosphodiesterase type 5 inhibitors, interferon alfa, antimycobacterial antibiotics, and nitroimidazole antibiotics. See Section 9.1 for additional details regarding excluded systemic medications.
- •Any current use of ocular medication with the exception of rewetting drops.
- •Any known hypersensitivity or allergic reaction to single use preservative free rewetting drops or sodium fluorescein.
- •Any previous or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK dacryocystorhinostomy, cataract surgery, retinal surgery, peripheral iridotomy/iridectomy, etc.).
- •Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
- •Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
- •Any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.
Outcomes
Primary Outcomes
Starburst Diameter (mm)
Time Frame: 30-minutes post lens insertion
The starburst diameter (mm) was measured each subject binocularly. Starburst diameter was quantified by the horizontal spread of the spokes emerging from the center of a small, point-like stimulus. A calibrated custom-made micrometer (two sides with reverse threading) was used to spread two posts out from a central mid-point. The posts attach to a custom-designed ruler that indicates the lateral spread of the starburst. Measurements for this metric are positive. Smaller diameter indicates better lens performance. The average diameter (mm) for each lens type was reported by period.
Halos Diameter (mm)
Time Frame: 30-minutes post lens insertion
Halo diameter (mm) was quantified and measured using the same micrometer as for starbursts diameter (mm). The Halo diameter (mm) was measured each subject binocularly. Measurements for halo diameter are positive, where smaller values indicate better performance. The average diameter (mm) for each lens type.
Glare Disability Threshold
Time Frame: 30-minutes post lens insertion
Glare disability threshold was collected binocularly for each subject. Subjects were exposed to a target stimulus for 2 seconds; before the measurement was taken the annulus was set to a level below that which would cause the target stimulus to be veiled. The experimenter would then adjust the intensity of the annulus until subjects could no longer see the target stimulus. Subjects would indicate this by pressing a buzzer. Glare disability thresholds take on positive values, where higher values indicate better lens performance. The average glare disability level (change in log relative energy) for each lens type was reported.
Secondary Outcomes
- Glare Discomfort (mm)(30-minutes post lens insertion)
- Heterochromatic Contrast Threshold (HCT)(30-minutes post lens insertion)
- Two-Point Threshold (mm) With 403nm Filter(30-minutes post lens insertion)
- Two-Point Threshold (mm) Without 403nm Filter(30-minutes post lens insertion)