Status:
COMPLETED
Assessment of an Investigational Frequent Replacement Silicone Hydrogel Lens
Lead Sponsor:
Alcon Research
Conditions:
Refractive Ametropia
Eligibility:
All Genders
18+ years
Phase:
NA
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 wea...
Detailed Description
Subjects will be expected to attend 9 office visits. The total expected duration of participation for each subject is approximately 12 months.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 26 2021
Estimated Enrollment :
675 Patients enrolled
Trial Details
Trial ID
NCT04085328
Start Date
October 11 2019
End Date
March 26 2021
Last Update
June 13 2023
Active Locations (42)
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1
Family EyeCare Center
Campbell, California, United States, 95008
2
Winston Eye Care
Fullerton, California, United States, 92835
3
Kurata Eye Care Center
Los Angeles, California, United States, 90012
4
East West Eye Institute
Los Angeles, California, United States, 90013