What have pre- and postapproval studies shown about contact lens-related inflammatory events?

Eye and Contact Lens

Volumn 33, Issue 6 PART 2 OF SUPPL 2, 2007, Pages 388-391

  Chalmers, Robin L ^a,b  

^a INDIANA UNIVERSITY   (United States)

^b NONE   (United States)

Author keywords

Inflammation; Refractive error; Registration trials; Silicone hydrogel contact lenses

Indexed keywords

SILICONE;

CONTACT LENS; HUMAN; HYDROGEL; KERATITIS; PATIENT SELECTION; PRIORITY JOURNAL; REFRACTION ERROR; REVIEW; RISK ASSESSMENT; SPECTACLES; VISION;

AGE FACTORS; CLINICAL TRIALS AS TOPIC; CONTACT LENSES; CONTACT LENSES, HYDROPHILIC; CORNEAL DISEASES; DEVICE APPROVAL; HUMANS; HYDROGEL; INFLAMMATION; ORTHOKERATOLOGIC PROCEDURES; PATIENT SELECTION; REFRACTIVE ERRORS; REGISTRIES; RISK FACTORS; SILICONES;

EID: 35848936273     PISSN: 15422321     EISSN: None     Source Type: Journal    
DOI: 10.1097/ICL.0b013e318157d8b5     Document Type: Review

References (11)

1. U.S. Food and Drug Administration. Premarket application summary of safety and effectiveness data. Pure Vision visibility tinted (balafilcon A) contact lenses. Available at: http://www.fda.gov/cdrh/pdf/P980006/S004b.doc. Accessed November 20, 2001.
2. U.S. Food and Drug Administration. Premarket application summary of safety and effectiveness data. CIBA Vision Focus Night and Day (lotrafilcon A) soft contact lens. Available at: http://www.fda.gov/cdrh/pdf/p000030b.doc. Accessed October 12, 2001.
3. Schein OD, McNally JJ, Katz J, et al. The incidence of microbial keratitis among wearers of a 30-day silicone hydrogel extended-wear contact lens. Ophthalmology 2005;112:2172-2179.
4. Chalmers RL, McNally J, Schein OD, et al. Risk factors for corneal infiltrates with continuous wear of contact lenses. Optom Vis Sci 2007;84:573-579.
5. U.S. Food and Drug Administration. Premarket application summary of safety and effectiveness data. Paragon-Z CRT (tisilfocon A) rigid gas permeable for corneal refractive therapy. Available at: http://www.fda.gov/cdrh//pdf/ P050031b.doc. Accessed November 16, 2006.
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7. Saviola JF. The current FDA view on overnight orthokeratology: How we got here and where we are going. Cornea 2005;24:770-771.
8. McNally JJ, Chalmers RL, McKenney CD, et al. Risk factors for corneal infiltrative events with 30-night continuous wear of silicone hydrogel lenses. Eye Contact Lens 2003;29 (1S):S153-S156.
9. Zadnik K, Mutti DO, Cutter GR, et al. The effect of degree of refractive error on hydrogel contact lens-induced complications and patient self-management behaviors. Optom Vis Sci 2001;78:652-656.
10. Bergenske P, Long B, Dillehay S, et al. Long term clinical results: 3 years of continuous wear of lotrafilcon A silicone hydrogel and daily wear of hydrogel lenses. Eye Contact Lens 2007;33:74-80.
11. Donshik P, Long B, Dillehay SM, et al. Inflammatory and mechanical complications associated with 3 years of up to 30 night continuous wear of lotrafilcon A silicone hydrogel lenses. Eye Contact Lens 2007;33:191-195.