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Trial record 1 of 1 for:    "Acanthamoeba Keratitis" | "Prednisolone acetate"
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Parasitic Ulcer Treatment Trial Pilot

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ClinicalTrials.gov Identifier: NCT03484507
Recruitment Status : Recruiting
First Posted : March 30, 2018
Last Update Posted : August 2, 2018
Sponsor:
Collaborator:
Research to Prevent Blindness
Information provided by (Responsible Party):
Jeremy Keenan, Francis I. Proctor Foundation

Brief Summary:
This is a study of optimal treatments for acanthamoeba keratitis. In the first part of the study, participants will be randomized to chlorhexidine monotherapy or chlorhexidine plus povidone iodine. After four weeks of therapy, participants will be re-randomized to early corticosteroids, later corticosteroids, or placebo.

Condition or disease Intervention/treatment Phase
Acanthamoeba Keratitis Drug: Chlorhexidine Drug: Povidone-Iodine Drug: Prednisolone Sodium Phosphate Drug: Hydroxypropyl Methylcellulose Phase 2

Detailed Description:

Acanthamoeba keratitis is a rare eye infection that is difficult to treat. The mainstay of therapy is a biguanide agent such as chlorhexidine, though recent studies have found povidone iodine to be effective for killing acanthamoeba organisms in vitro. Thus, we randomize participants to topical chlorhexidine 0.04% monotherapy (i.e., routine care) versus topical chlorhexidine 0.04% plus topical poviodine iodine 2.5%. The primary outcome is clearance of acanthamoeba from the ocular surface at 4 weeks.

The role of topical corticosteroids in acanthamoeba keratitis is controversial. Topical corticosteroids can promote growth of acanthamoeba, but may also reduce inflammation and vision-threatening complications of infection. Here, we randomize participants who have completed a course of anti-amoebic therapy to one of three groups: early prednisolone sodium phosphate 1% (started at 4 weeks), late prednisolone sodium phosphate 1% (started at 6 weeks) or placebo (started at 4 weeks). The primary outcome will be visual acuity at 6 months.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Parasitic Ulcer Treatment Trial Pilot
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023


Arm Intervention/treatment
Active Comparator: Chlorhexidine monotherapy
Topical chlorhexidine 0.04%
Drug: Chlorhexidine
1 drop half-hourly for days 1-2, then hourly for days 3-6, then 8 times daily until the 4-week visit

Experimental: Chlorhexidine plus povidone iodine
Topical chlorhexidine 0.04% plus povidone iodine 2.5%
Drug: Chlorhexidine
1 drop half-hourly for days 1-2, then hourly for days 3-6, then 8 times daily until the 4-week visit

Drug: Povidone-Iodine
1 drop half-hourly for days 1-2, then hourly for days 3-6, then 8 times daily until the 4-week visit

Experimental: Early corticosteroids
Topical prednisolone sodium phosophate 1% for weeks 4-11
Drug: Prednisolone Sodium Phosphate
1 drop 4 times daily for weeks 4-9, then 2 times daily for weeks 10-11

Experimental: Late corticosteroids
Artificial tears for weeks 4-5, then topical prednisolone sodium phosophate 1% for weeks 6-11
Drug: Prednisolone Sodium Phosphate
1 drop 4 times daily for weeks 6-9, then 2 times daily for weeks 10-11

Drug: Hydroxypropyl Methylcellulose
1 drop 4 times daily for weeks 4-5

Placebo Comparator: Placebo
Artificial tears for weeks 4-11
Drug: Hydroxypropyl Methylcellulose
1 drop 4 times daily for weeks 4-9, then 2 times daily for weeks 10-11




Primary Outcome Measures :
  1. Trial 1: Microbial clearance [ Time Frame: 4 weeks ]
    Acanthamoeba culture

  2. Trial 2: Best spectacle corrected visual acuity [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Trial 1: Best spectacle corrected visual acuity [ Time Frame: 4 weeks ]
  2. Trial 1: Time to re-epithelialization [ Time Frame: 4 weeks ]
  3. Trial 1: Clinical cure [ Time Frame: 4 weeks ]
  4. Trial 2: Time to clinical cure [ Time Frame: 6 months ]


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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Trial 1 Inclusion Criteria:

  • Smear or culture positive for acanthamoeba
  • Age 13 years or greater

Trial 1 Exclusion Criteria:

  • Interstitial or viral keratitis on history or examination
  • Corneal perforation
  • Therapeutic keratoplasty for acanthamoeba keratitis
  • Unwillingness or inability to follow-up (e.g., living too far from hospital)

Trial 2 Inclusion Criteria

  • Smear or culture positive for acanthamoeba, with 4 weeks of anti-amoebic treatment
  • Age 13 years or greater
  • Willing to participate in study

Trial 2 Exclusion Criteria

  • Interstitial or viral keratitis on history or examination
  • Fungus identified on culture and smear after 2 weeks of anti-amoebic treatment
  • Corneal perforation
  • Therapeutic keratoplasty for acanthamoeba keratitis
  • Unwillingness or inability to follow-up (e.g., living too far from hospital)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03484507


Contacts
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Contact: Jeremy D Keenan, MD 415-476-1442 jeremy.keenan@ucsf.edu
Contact: Caitlin Moe, MPH 415-502-2665 caitlin.moe@ucsf.edu

Locations
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India
Aravind Eye Hospital Recruiting
Coimbatore, Tamil Nadu, India
Contact: Revathi Rajaraman         
Aravind Eye Hospital Recruiting
Madurai, Tamil Nadu, India
Contact: Arun Panigrahi         
Sponsors and Collaborators
Francis I. Proctor Foundation
Research to Prevent Blindness
Investigators
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Principal Investigator: Jeremy D Keenan, MD University of California, San Francisco

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Responsible Party: Jeremy Keenan, Professor of Ophthalmology, Francis I. Proctor Foundation
ClinicalTrials.gov Identifier: NCT03484507     History of Changes
Other Study ID Numbers: UCSF-IRB-17-23895
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Acanthamoeba Keratitis
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Keratitis
Corneal Diseases
Eye Diseases
Eye Infections, Parasitic
Parasitic Diseases
Amebiasis
Protozoan Infections
Eye Infections
Iodine
Chlorhexidine
Chlorhexidine gluconate
Povidone-Iodine
Povidone
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs