Clinical Safety and Effectiveness Assessment of an Investigational Frequent Replacement Silicone Hydrogel Lens
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Refractive Ametropia
- Sponsor
- Alcon Research
- Enrollment
- 675
- Locations
- 42
- Primary Endpoint
- Distance Visual Acuity (VA) With Study Lenses - Completed Eyes
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this clinical trial is to evaluate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in an extended wear modality.
Detailed Description
Subjects will be expected to attend 9 office visits. The total expected duration of participation for each subject is approximately 12 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Able to understand and sign an Informed Consent Form.
- •Willing to attend all scheduled study visits as required per protocol.
- •Willing and able to wear assigned study lenses as required per protocol.
- •Successful wear of spherical daily wear or extended wear frequent replacement soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week.
- •Manifest cylinder ≤ 0.75 diopter (D) in each eye.
- •Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- •Any eye infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator.
- •Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator.
- •History of eye surgery, including refractive surgery.
- •Currently pregnant or breast-feeding.
- •Monovision contact lens wearers.
- •Daily disposable contact lens wearers.
- •Other protocol-specified exclusion criteria may apply.
Outcomes
Primary Outcomes
Distance Visual Acuity (VA) With Study Lenses - Completed Eyes
Time Frame: Day 1 Dispense; Hour 24 Follow-Up; Week 1 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up; Month 6 Follow-up; Month 9 Follow-up, Month 12 Follow-up
Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed.
Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes
Time Frame: Day 1 Dispense; Hour 24 Follow-Up; Week 1 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up; Month 6 Follow-up; Month 9 Follow-up
Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed.
Proportion of Ocular Serious and Significant Non-serious Adverse Device Effects (ADEs)
Time Frame: Up to Month 12
Calculated as the total number of eyes reporting at least one treatment-emergent, ocular, serious ADE or treatment-emergent, ocular, significant, non-serious ADE, divided by the total number of eyes enrolled and dispensed. An ADE was defined as any adverse event related to the use of the investigational medical device (LID015385) or control product (Biofinity).