Clinical Evaluation of a Manufacturing Process for a Frequent Replacement Silicone Hydrogel Multi⦠(NCT05765227) | Clinical Trial Compass
CompletedNot Applicable
Clinical Evaluation of a Manufacturing Process for a Frequent Replacement Silicone Hydrogel Multifocal Contact Lens
United States18 participantsStarted 2023-03-08
Plain-language summary
The purpose of this clinical trial was to evaluate the clinical performance of a manufacturing process on a frequent replacement multifocal contact lens.
Who can participate
Age range40 Years
SexALL
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Key Inclusion Criteria:
* Able to understand and sign an consent form (ICF) that has been approved by an Institutional Review Board (IRB);
* Willing to stop wearing habitual contact lenses for the duration of study participation;
* Currently wearing multifocal soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
* Other protocol-defined inclusion criteria may apply.
Key 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 refractive surgery, or plan to have refractive surgery during the study;
* Current or history of dry eye in either eye that would preclude contact lens wear, in the opinion of the investigator;
* Monovision contact lens wear;
* Other protocol-defined exclusion criteria may apply.
What they're measuring
1
Binocular Visual Acuity (VA) With Study Lenses at 4 Meters (logMAR)
Timeframe: Day 2, each study lens type worn during the corresponding crossover period