The ocular surface · 2019
Safety and tolerability of a one-time, in-office administration of 5% povidone-iodine in the treatment of adenoviral conjunctivitis: The Reducing Adenoviral Patient Infected Days (RAPID) study.
СтатьяРандомизированное исследованиеПоддержка NIH: внешняя программаПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
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Shorter Ellen, Whiteside Meredith, Harthan Jennifer, Margolis Mathew S, Hartwick Andrew T, Johnson Spencer, Migneco Mary, Morettin Christina, Olson Christian K, Huecker Julia, Than Tammy, Gordon Mae O
Аннотация
PURPOSE: To report safety and tolerability of a one-time administration of ophthalmic 5% povidone-iodine (5% PVP-I) in a double-masked randomized trial for the treatment of adenoviral conjunctivitis (Ad-Cs).
METHODS: Of 212 participants screened, 56 eligible participants with red eye symptoms ≤4 days and a positive adenoviral rapid immunoassay were randomized to a one-time administration of ophthalmic 5% PVP-I or preservative free artificial tears (AT). Safety was assessed by corneal fluorescein staining (baseline, immediate post-administration and Day 1) and visual acuity (VA) (baseline and Day 1). Tolerability was assessed using participant-rated overall ocular discomfort (baseline, immediately post-administration and on Day 1.
RESULTS: In the 5% PVP-I group, corneal staining increased immediately post-administration but returned to baseline levels by Day 1. There was no change in VA between baseline and Day 1 in either 5% PVP-I or AT groups (p = 0.87). In the 5% PVP-I group, there was no change in participant-rated overall discomfort immediately post-administration (p = 0.78) or on day 1 (p = 0.10) compared to baseline. In the AT group, participant-rated overall discomfort was lower immediately post-administration but returned to baseline levels by Day 1. One adverse event was reported in the 5% PVP-I group on Day 1-2 that was classified as not related to treatment.
CONCLUSION: These results suggest ophthalmic 5% PVP-I used as a one-time treatment is safe and well tolerated by patients with Ad-Cs.
METHODS: Of 212 participants screened, 56 eligible participants with red eye symptoms ≤4 days and a positive adenoviral rapid immunoassay were randomized to a one-time administration of ophthalmic 5% PVP-I or preservative free artificial tears (AT). Safety was assessed by corneal fluorescein staining (baseline, immediate post-administration and Day 1) and visual acuity (VA) (baseline and Day 1). Tolerability was assessed using participant-rated overall ocular discomfort (baseline, immediately post-administration and on Day 1.
RESULTS: In the 5% PVP-I group, corneal staining increased immediately post-administration but returned to baseline levels by Day 1. There was no change in VA between baseline and Day 1 in either 5% PVP-I or AT groups (p = 0.87). In the 5% PVP-I group, there was no change in participant-rated overall discomfort immediately post-administration (p = 0.78) or on day 1 (p = 0.10) compared to baseline. In the AT group, participant-rated overall discomfort was lower immediately post-administration but returned to baseline levels by Day 1. One adverse event was reported in the 5% PVP-I group on Day 1-2 that was classified as not related to treatment.
CONCLUSION: These results suggest ophthalmic 5% PVP-I used as a one-time treatment is safe and well tolerated by patients with Ad-Cs.