Clinical and Theoretical Evaluation of Factors Affecting Soft Toric Lens Performance: Part 3
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Astigmatism
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Visual Acuity During Head Tilt
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to determine the relative performance of a new toric soft contact lens against three toric contact lens currently available in market, specifically with orientation and visual acuity when head is tilted at 90 degrees.
Detailed Description
Non-dispensing single-masked (subject-masked), randomised, 1-visit controlled study, \~2 hour duration.
Investigators
Eligibility Criteria
Inclusion Criteria
- •be at least 18 and less than or equal to 50 years of age
- •be able and willing to adhere to the instructions set forth in the protocol.
- •have a distance spherical component between -1.00 D and -6.00D with cylinder in the range of 0.75 D to 1.75D
- •Sign the STATEMENT OF INFORMED CONSENT.
- •Have normal, healthy eyes
Exclusion Criteria
- •The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear.
- •Pre-existing ocular disease precluding contact lens fitting.
- •Insufficient lacrimal secretions
- •Aphakia, keratoconus or a highly irregular cornea
- •Previous eye surgery involving the anterior segment
- •Current pregnancy or lactation (to the best of the subject's knowledge).
- •Use of concurrent ocular medication
- •Active participation in another clinical study at any time during this study.-
Outcomes
Primary Outcomes
Visual Acuity During Head Tilt
Time Frame: after each of the four lens insertions
logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
Lens Orientation During Head Tilt.
Time Frame: after fit of each of the four lens insertions
Degree of lens rotation on the eye with the head tilted.
Secondary Outcomes
- Degree of Lens Rotation in Temporal Gaze.(After each of the four lens insertions)
- Degree of Lens Rotation in Superior Gaze.(After each of the four lens insertions)
- Degree of Lens Rotation in Superior-temporal Gaze.(After each of 4 lens insertions.,)
- Degree of Lens Rotation in Inferior Gaze.(After each of the four lens insertions)
- Degree of Lens Rotation Inferior-temporal Gaze.(After each of the four lens insertions)
- Degree of Lens Rotation in Superior-nasal Gaze.(After each of the four lens insertions)
- Degree of Lens Rotation in Nasal Gaze.(After each of the four lens insertions)
- Degree of Lens Rotation in Inferior-nasal Gaze.(After each of the four lens insertions)