Clinical Performance of Samfilcon A, a Unique Silicone Hydrogel Lens, on a 7-Day Extended Wear Basis
| Autor: | Howard M. Proskin, Marjorie J Rah, William Reindel, Gary Mosehauer, Robert Steffen |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
Corneal staining Slit lamp genetic structures business.industry Clinical performance Both lenses Extended wear Silicone hydrogel eye diseases law.invention Contact lens Lens (optics) 03 medical and health sciences Ophthalmology 0302 clinical medicine law 030221 ophthalmology & optometry medicine sense organs business 030217 neurology & neurosurgery |
| Zdroj: | Clinical Ophthalmology. 14:3457-3464 |
| ISSN: | 1177-5483 |
| DOI: | 10.2147/opth.s268286 |
| Popis: | Purpose The objective of this study was to evaluate and compare the clinical performance of samfilcon A, a unique, polyvinylpyrrolidone (PVP)-containing, silicone hydrogel contact lens with that of the balafilcon A silicone hydrogel contact lens when worn on a 7-day extended wear basis. Subjects and Methods A total of 669 subjects completed this 12-month, controlled, parallel group, masked, randomized study; of these, 340 wore samfilcon A lenses and 329 balafilcon A lenses. Subjects wore their respective assigned lenses bilaterally on a 7-day extended wear basis. On the seventh night of each wearing week, lenses were removed, cleaned, and disinfected using Biotrue multi-purpose solution (MPS), then re-inserted the following morning. Lenses were replaced with new lenses monthly. At each follow-up visit, investigators completed a slit lamp evaluation, and subjects rated lenses based upon a predefined set of performance criteria. Results The samfilcon A lens performed comparably to the balafilcon A lens in terms of most graded and ungraded slit lamp findings, differing significantly only for corneal staining Grade 2 or greater, which favored samfilcon A, and anterior segment abnormalities, which favored balafilcon A. Subjects rated both lenses highly when queried about various lens-wearing characteristics. When comparing the number of subjects with findings on either eye on at least one follow-up visit, the two lenses were comparable in many aspects but favored samfilcon A with respect to cleanliness upon removal, overall comfort, comfort at end of day, dryness, vision, vision in low light, vision at end of day, and overall impression (all p < 0.05). Conclusion While subjects rated both highly, samfilcon A lenses worn for 7-day extended wear and replaced on a monthly basis performed comparably to or better than balafilcon A lenses when worn for the same 7-day wear time and replacement cycle. |
| Databáze: | OpenAIRE |
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