Not Yet RecruitingPhase 2ACTRN12613000460707

A Pilot Study: The effect of in-office irrigation with 5% povidone-iodine to reduce the duration of adenoviral conjunctivitis

A Pilot Study: The effect of in-office irrigation with 5% povidone-iodine compared to placebo, at time of adenoviral conjunctivitis diagnosis, on shortening the infectious period of adenoviral conjunctivitis.


Sponsor

Ben Ashby

Enrollment

12 participants

Start Date

May 13, 2013

Study Type

Interventional

Conditions

Summary

The primary purpose of this pilot study aims to determine the effectiveness of treating this particular viral eye infection (adenoviral conjunctivitis) with a one-time in-office irrigation of the eye with 5% povidone-iodine. We aim to determine whether this treatment reduced the period of infection as well as improving patient’s symptoms'.


Eligibility

Sex: Both males and femalesMin Age: 14 Yearss

Inclusion Criteria1

  • Patients must have a positive result on the RPS Adeno Detector, plus at least one of the clinical signs of conjunctival redness, follicles or lymph adenopathy; and at least one of the symptoms of irritation, watering or photophobia.

Exclusion Criteria11

  • Patient with a history of allergy to anaesthetic eye drops or a known sensitivity to iodine.
  • Patient who are susceptible to having an adverse reaction to NSAIDs, have a contraindication or are on medications that may interact adversely with ibuprofen. This includes the following:
  • An history of allergy to NSAID
  • Asthmatic patient
  • Gastrointestinal disorders (or history of), including dyspepsia, Crohn’s disease, colitis, gastrointestinal haemorrhage, perforation or ulcer, melaena
  • Heart/cardiac impairment (or history of), including cardiac failure, myocardial infarction (heart attack), angina pectoris, stroke
  • Liver disorders (or history of), including hepatitis, jaundice and abnormal hepatic function
  • Kidney/renal impairment (or history of), including haemutria, interstitial nephritis, renal failure, nephrotic syndrome, proteinuria, renal papillary necrosis
  • Pregnant or breastfeeding women
  • Hypertension including those on hypertension medication
  • Currently taking the following medications: aspirin, diuretics, lithium, hypertensive drugs including ACE inhibitors, beta blockers and diuretics, steroids, zidovudine, probenecid, antidiabetic medication, phenytoin, methotrexate, anticoagulants, SSRIs.

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Interventions

Patients will be given 2 tablets of 200mg ibuprofen in office prior to treatment. 2 drops of 0.4% preservative-free oxybuprocaine will be placed in the lower lid of both eyes prior to treatment. This

Patients will be given 2 tablets of 200mg ibuprofen in office prior to treatment. 2 drops of 0.4% preservative-free oxybuprocaine will be placed in the lower lid of both eyes prior to treatment. This is followed by 5 drops of 5% povidone-iodine in both eyes. 0.9% sterile sodium chloride wil be used to completely irrigate both eyes for 60 seconds after povidone-iodine application. Preservative-free Blink Intensive tears (active ingredient: polyethylene glycol 0.25%) will be given and the participant will be instructed to place 1 drop in both eyes every 2 hours until the first review the next day, and as required thereafter. Participants will be asked on the frequency of using the drops at follow-up examinations.


Locations(1)

NSW, Australia

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ACTRN12613000460707