Clinical Characterization of an Investigational Soft Silicone Hydrogel Contact Lens
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Refractive Errors
- Sponsor
- Alcon Research
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Front Surface Wettability, by Category
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The primary objective of this study is to evaluate the overall clinical performance of an investigational silicone hydrogel contact lens over 2 weeks of daily wear.
Detailed Description
Participants will attend a Screening visit, a Dispense visit (0 to 4 days later), and a follow-up visit approximately 2 weeks after the Dispense visit.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Understand and sign an Informed Consent that has been approved by an Institutional Review Board.
- •Successful wear of spherical weekly/monthly soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
- •Willing to stop wearing habitual contact lenses for the duration of study participation.
- •Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- •Any condition that contraindicates contact lens wear, as determined by the Investigator.
- •Any use of systemic or ocular medications that contraindicates contact lens wear, as determined by the Investigator.
- •History of refractive surgery or plan to have refractive surgery during the study.
- •Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear.
- •Habitual contact lenses worn in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
- •Any use of topical ocular medications or artificial tear or rewetting drops that would require instillation during contact lens wear.
- •Monovision or multifocal contact lens wear.
- •Other protocol-defined exclusion criteria may apply.
Outcomes
Primary Outcomes
Front Surface Wettability, by Category
Time Frame: Dispense; Week 2 Follow-up
Front surface wettability (i.e., assessment of the disruption of the front surface wettability of the contact lens) was assessed by the investigator for each eye individually. Front surface wettability was collected on a 5-point scale, where where Grade 0 = a smooth uniformly reflecting surface and Grade 4 = non-wettable lens surface. No formal hypothesis was predefined for the primary endpoint. No inferential testing was performed.