Reducing Adenoviral Patient Infected Days (RAPID) Study: Success in Masking Subjects and Clinicians From Identifying Treatment with Ophthalmic Povidone-Iodine 5% (PVP-I).

Abstract

Purpose : The Reducing Adenoviral Patient Infected Days (RAPID) study is a double-masked randomized pilot trial of the safety and efficacy of a one-time, administration of ophthalmic PVP-I 5%. Masking both the participant and the study clinician are important to minimize bias in endpoint assessments in well-conducted clinical trials.

Methods : Eligibility included informed consent, age ≥18, new onset red eye with symptoms ≤4 days and a positive in-office AdenoPlus rapid immunoassay test for adenoviral conjunctivitis. The study eye was randomized to receive a one-time in office treatment of either PVP-I or artificial tears (ATs). After 1 drop of ophthalmic proparacaine 0.5%, 4-5 drops of PVP-I or ATs were placed in the eye. Two minutes after instillation, the eye was lavaged with preservative-free sterile saline. Immediately after treatment and at the day 4 visit, participants were asked to guess whether they received PVP-I, ATs or if they were unsure. On day 14, masked clinicians were asked which treatment they believed the participant received.

Results : At baseline, correct guesses were made by 64% (16/25) of subjects randomized to PVP-I treatment and 29% (7/24) of those randomized to ATs. Overall, 47% (23/49) of participants guessed correctly and 41% (20/49) were unsure. At four days post-treatment, correct guesses were made in 68% (13/19) of subjects receiving PVP-I and 45% (9/20) of participants who received ATs. Overall, 56% (22/39) of participants guessed correctly and 26% (10/39) were unsure on day 4. On day 14, masked clinicians correctly guessed the treatment in 56% (9/16) of the PVP-I group, in 67% (10/15) of the AT group. The clinician correctly guessed the treatment assignment 61% (19/31) and they were unsure 26% (8/31) of the time.

Conclusions : While overall masking of subjects on day 0 and day 4 post treatment was achieved, treatment with PVP-I was more difficult to mask. Clinician masking was less successful than overall subject masking.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.

 

Summary of Results