Clinical Comparison of Two Daily Disposable Soft Contact Lenses
Not Applicable
Completed
- Conditions
- Refractive ErrorsMyopia
- Interventions
- Device: verofilcon A contact lensesDevice: somofilcon A contact lenses
- Registration Number
- NCT03518008
- Lead Sponsor
- Alcon Research
- Brief Summary
The purpose of this study is to evaluate the overall performance of investigational contact lenses (DD T2) when compared to clariti® 1 day contact lenses.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
Inclusion Criteria
- Understand and sign an Informed Consent Form;
- Successful wear of daily disposable spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
- Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
- Willing to stop wearing habitual contact lenses for the duration of study participation;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Anterior segment infection, inflammation, or abnormality or disease that contraindicates contact lens wear, as determined by the Investigator;
- Use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
- Refractive, ocular, or intraocular surgery, as specified in the protocol;
- Eye condition or injury, as specified in the protocol;
- Current or history of intolerance, hypersensitivity, or allergy to any component of the study products;
- Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
- Use of topical ocular medications and artificial tear or rewetting drops requiring instillation during contact lens wear;
- Currently wearing clariti® 1 day contact lenses;
- Habitually wearing monovision or multifocal lenses during the last 3 months;
- Other protocol-specified exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description DD T2, then Clariti 1 Day verofilcon A contact lenses Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable modality. DD T2, then Clariti 1 Day somofilcon A contact lenses Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable modality. Clariti 1 Day, then DD T2 somofilcon A contact lenses Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second. Each product worn bilaterally for 1 week in a daily disposable modality. Clariti 1 Day, then DD T2 verofilcon A contact lenses Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second. Each product worn bilaterally for 1 week in a daily disposable modality.
- Primary Outcome Measures
Name Time Method Overall Quality of Vision Day 8, each product Overall quality of vision was measured as a subjective rating, collected binocularly on a scale of 1 (Poor) to 10 (Excellent). No inferences were made; therefore, no hypotheses were formulated.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Alcon Investigative Site
🇺🇸Maitland, Florida, United States