César Lipener1. 1. Contact Lens Department of Universidade Federal de São Paulo, Paraíso, Brazil. lipener@uol.com.br
Abstract
OBJECTIVE: To evaluate subjective symptoms and clinical signs of tolerability and comfort in silicone and non-silicone hydrogel contact lens (CL) wearers using two different multipurpose solution (MPS) CL care regimens. METHODS: This was a randomized, double-masked, contralateral, crossover, multicenter (n=9) study. One hundred and eleven subjects were enrolled in the study, and were randomly assigned either silicone hydrogel CLs or non-silicone hydrogel CLs. Before wear, the CLs were randomly conditioned for at least 10 hours in a multipurpose disinfection solution (MPDS) preserved with either: Regimen 1-polyquaternium-1 0.001% and myristamidopropyl dimethylamine 0.0005% (POLYQUAD and ALDOX, respectively; OPTIFREE EXPRESS MPDS, Alcon Laboratories, Inc., Fort Worth, TX, USA); or Regimen 2-multipurpose solution preserved with polyhexamethylene biguanide 0.0001% (PHMB, ReNu MultiPLUS MPS, Bausch & Lomb, Rochester, NY, USA). The study had two in-office visits, 1 week apart. Subjects wore assigned CLs for approximately 4 hours at each visit. At each visit, subjects' eyes were examined before CL insertion and at 2 hours and 4 hours after insertion. Corneal staining type and area, conjunctival staining, conjunctival injection, subjective symptoms (tolerability), and comfort were evaluated. RESULTS:One hundred and five subjects (210 eyes) completed the study. The total corneal staining score of area and type were statistically significantly less in Regimen 1 than in Regimen 2 (P<0.000001). The area of conjunctival staining was statistically significantly less in Regimen 1 than in Regimen 2 (P=0.03). No clinically significant hyperemia was observed for either regimen. Both tolerability (P=0.02) and patient preference (P=0.05) were in favor of Regimen 1. CONCLUSIONS: Statistically significant clinical differences were evident between the two CL care regimens when used with silicone and non-silicone hydrogel CLs. OPTI-FREE EXPRESS MPDS users showed less corneal and conjunctival staining and reported greater comfort and tolerability to the CL/solution combination than ReNu MultiPLUS MPS users.
RCT Entities:
OBJECTIVE: To evaluate subjective symptoms and clinical signs of tolerability and comfort in silicone and non-silicone hydrogel contact lens (CL) wearers using two different multipurpose solution (MPS) CL care regimens. METHODS: This was a randomized, double-masked, contralateral, crossover, multicenter (n=9) study. One hundred and eleven subjects were enrolled in the study, and were randomly assigned either silicone hydrogel CLs or non-silicone hydrogel CLs. Before wear, the CLs were randomly conditioned for at least 10 hours in a multipurpose disinfection solution (MPDS) preserved with either: Regimen 1-polyquaternium-1 0.001% and myristamidopropyl dimethylamine 0.0005% (POLYQUAD and ALDOX, respectively; OPTIFREE EXPRESS MPDS, Alcon Laboratories, Inc., Fort Worth, TX, USA); or Regimen 2-multipurpose solution preserved with polyhexamethylene biguanide 0.0001% (PHMB, ReNu MultiPLUS MPS, Bausch & Lomb, Rochester, NY, USA). The study had two in-office visits, 1 week apart. Subjects wore assigned CLs for approximately 4 hours at each visit. At each visit, subjects' eyes were examined before CL insertion and at 2 hours and 4 hours after insertion. Corneal staining type and area, conjunctival staining, conjunctival injection, subjective symptoms (tolerability), and comfort were evaluated. RESULTS: One hundred and five subjects (210 eyes) completed the study. The total corneal staining score of area and type were statistically significantly less in Regimen 1 than in Regimen 2 (P<0.000001). The area of conjunctival staining was statistically significantly less in Regimen 1 than in Regimen 2 (P=0.03). No clinically significant hyperemia was observed for either regimen. Both tolerability (P=0.02) and patient preference (P=0.05) were in favor of Regimen 1. CONCLUSIONS: Statistically significant clinical differences were evident between the two CL care regimens when used with silicone and non-silicone hydrogel CLs. OPTI-FREE EXPRESS MPDS users showed less corneal and conjunctival staining and reported greater comfort and tolerability to the CL/solution combination than ReNu MultiPLUS MPS users.
Authors: Gabriel M Gordon; Navid Moradshahi; Shinwu Jeong; Christianne Lane; M Elizabeth Fini Journal: Invest Ophthalmol Vis Sci Date: 2011-11-25 Impact factor: 4.799