TY - JOUR
T1 - Topical Application of Naltrexone to the Ocular Surface of Healthy Volunteers
T2 - A Tolerability Study
AU - Liang, David
AU - Sassani, Joseph W.
AU - McLaughlin, Patricia J.
AU - Zagon, Ian S.
PY - 2016/3
Y1 - 2016/3
N2 - Purpose: A short-term, randomized double-masked study was conducted to test the tolerability of topical application of naltrexone to the corneal surface. Methods: Healthy human volunteers were recruited at the Penn State Hershey Medical Center between 2010 and 2013. Study groups of 4 subjects were established to receive escalating dosages of naltrexone; within each group, 1 subject received placebo. Four drops of 4 different dosages of naltrexone dissolved in commercial moxifloxacin solution were administered over a 24-h period of time; 1 group of subjects received only 1 drop. The naltrexone dosages tested were 1 × 10-6 M (1 drop), 1 × 10-6 M (4 drops), 5 × 10-6 M (4 drops), 1 × 10-5 M (4 drops), and 5 × 10-5 M (4 drops). Drops were administered over a 24-h period. Consenting subjects had complete eye examinations, including visual acuity (ETDRS), external and slit-lamp examinations, corneal sensitivity, pachymetry, corneal topography, endothelial specular microscopy, Schirmer testing with anesthetic, and fundus photography, before receiving naltrexone. Individuals were reexamined at 24 h and 7 days following naltrexone or placebo application. Results: Twenty subjects were recruited for the study; 62% were male, 90% were Caucasian; and 19 subjects completed the study. No significant differences were noted in ocular health between left (treated) and right (untreated) eyes of subjects receiving naltrexone or placebo. No significant adverse events were reported. Conclusions: Topical naltrexone was well tolerated in healthy human subjects after 1 or 4 eye drops of naltrexone at dosages up to 50 μM administered over a 24-h treatment period and observed for 1 week.
AB - Purpose: A short-term, randomized double-masked study was conducted to test the tolerability of topical application of naltrexone to the corneal surface. Methods: Healthy human volunteers were recruited at the Penn State Hershey Medical Center between 2010 and 2013. Study groups of 4 subjects were established to receive escalating dosages of naltrexone; within each group, 1 subject received placebo. Four drops of 4 different dosages of naltrexone dissolved in commercial moxifloxacin solution were administered over a 24-h period of time; 1 group of subjects received only 1 drop. The naltrexone dosages tested were 1 × 10-6 M (1 drop), 1 × 10-6 M (4 drops), 5 × 10-6 M (4 drops), 1 × 10-5 M (4 drops), and 5 × 10-5 M (4 drops). Drops were administered over a 24-h period. Consenting subjects had complete eye examinations, including visual acuity (ETDRS), external and slit-lamp examinations, corneal sensitivity, pachymetry, corneal topography, endothelial specular microscopy, Schirmer testing with anesthetic, and fundus photography, before receiving naltrexone. Individuals were reexamined at 24 h and 7 days following naltrexone or placebo application. Results: Twenty subjects were recruited for the study; 62% were male, 90% were Caucasian; and 19 subjects completed the study. No significant differences were noted in ocular health between left (treated) and right (untreated) eyes of subjects receiving naltrexone or placebo. No significant adverse events were reported. Conclusions: Topical naltrexone was well tolerated in healthy human subjects after 1 or 4 eye drops of naltrexone at dosages up to 50 μM administered over a 24-h treatment period and observed for 1 week.
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U2 - 10.1089/jop.2015.0070
DO - 10.1089/jop.2015.0070
M3 - Article
C2 - 26741052
AN - SCOPUS:84959341179
VL - 32
SP - 127
EP - 132
JO - Journal of Ocular Pharmacology and Therapeutics
JF - Journal of Ocular Pharmacology and Therapeutics
SN - 1080-7683
IS - 2
ER -