Clinical Validation Study of Phoebe Lens
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myopia
- Sponsor
- Coopervision, Inc.
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Corneal Staining Extent
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to validate the clinical performance of a new contact lens design.
Detailed Description
Evaluate the clinical performance of its Phoebe contact lenses (Test) compared to the commercially available MyDay contact lenses (Control).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Corneal Staining Extent
Time Frame: Day 3
Measurement of extent of corneal staining using Fluorescein, blue light, yellow filter, full beam, medium magnification on a scale 0-4 (0=no staining, 1 = 1-15% of area, 2= 16-30% of area, 3=31-45% of area, 4=\>45% of area).
Palpebral Hyperemia on Upper Lid
Time Frame: Day 3
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Palpebral Roughness Grade - Upper Lid
Time Frame: Day 3
Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Conjunctival Staining Score
Time Frame: Day 3
Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps
Palpebral Hyperemia on Lower Lid
Time Frame: Day 3
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Palpebral Roughness Grade - Lower Lid
Time Frame: Day 3
Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Secondary Outcomes
- Distance Visual Acuity(Day 3)
- Near Visual Acuity(Day 3)
- Vision Quality Rating(Day 3)