Parasitic Ulcer Treatment Trial

Conditions

• Acanthamoeba Keratitis

Eligibility Criteria

Sex

ALL

Age

8 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Polyhexamethylene biguanide (PHMB) — DRUG
  PHMB is a cationic antiseptic agent used for topical treatment of acanthamoeba keratitis (AK). Both treatment groups will take PHMB at least 4 times daily while on the allocated study drug.
• Topical corticosteroid — DRUG
  Dexamethasone sodium phosphate, 0.1% ophthalmic solution will be administered 4 times daily for 4 weeks, then 2 times daily for 2 weeks, then 1 time daily for 2 weeks.
• Topical placebo — OTHER
  An artificial tear ophthalmic solution will be administered 4 times daily for 4 weeks, then 2 times daily for 2 weeks, then 1 time daily for 2 weeks.

Study Details

The Parasitic Ulcer Treatment Trial (PUTT) is a multi-center, parallel-group, randomized clinical trial. The purpose of this study is to determine whether including topical corticosteroids in a regimen for acanthamoeba keratitis (AK) will improve vision. Patients presenting to all enrollment centers with evidence of acanthamoeba keratitis will be eligible for the trial if there is evidence of ocular inflammation after 4 weeks of anti-amoebic therapy. Those who agree to participate will be randomized to one of two treatment groups: * Group 1: Topical corticosteroid * Group 2: Topical placebo

Key Dates

Start date

Jul 1, 2024

Status verified

Apr 2026

Primary completion

Jul 31, 2029

Completion

Jul 31, 2029

Study Design

Enrollment

232 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Topical steroids
  Participants in this arm will receive anti-amoebic therapy plus topical steroids.
• Placebo Comparator: Topical placebo
  Participants in this arm will receive anti-amoebic therapy plus topical placebo.

Primary Outcome Measure

Vision [ Time Frame: 6 Months ]

Central Contacts

• Jeremy Keenan, MD, MPH
  415-476-6323
  [email protected]
• Krisi Aromin
  [email protected]

Locations (13)

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