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Artificial Tears Versus Preservative Free Ketorolac Trometamol 0.45% for Acute Viral Conjunctivitis

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ClinicalTrials.gov Identifier: NCT01799863
Recruitment Status : Completed
First Posted : February 27, 2013
Last Update Posted : April 8, 2015
Sponsor:
Information provided by (Responsible Party):
Fundação Altino Ventura

Tracking Information
First Submitted Date  ICMJE February 22, 2013
First Posted Date  ICMJE February 27, 2013
Last Update Posted Date April 8, 2015
Study Start Date  ICMJE June 2012
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2013)
  • Change in ocular symptoms from baseline to treatment day 7 [ Time Frame: 7 days ]
    General ocular discomfort, itching, foreign body sensation, tearing, eye redness and eyelid edema. Symptoms will be graded as 0 (absence), I (mild), II (moderate) and III (severe).
  • Change in ocular signs from baseline to treatment day 7 [ Time Frame: 7 days ]
    The clinical examination will consist of slit-lamp examination of the anterior segment. Four signs will be assessed: conjunctival hyperemia, chemosis, secretion and follicles in lower tarsal conjunctiva. The signs will be classified as 0 (absence), I (mild), II (moderate), III (severe)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Artificial Tears Versus Preservative Free Ketorolac Trometamol 0.45% for Acute Viral Conjunctivitis
Official Title  ICMJE Artificial Tears Versus Preservative Free Ketorolac Trometamol 0.45% for Treatment of Acute Viral Conjunctivitis
Brief Summary The purpose of this study is to evaluate the evolution of the symptoms of acute viral conjunctivitis using preservative free ketorolac trometamol 0.45% associated with carboxymethylcellulose compared with isolated use of preservative-free artificial tears.
Detailed Description The purpose of this study is to evaluate the evolution of the symptoms of acute viral conjunctivitis using preservative free ketorolac trometamol 0.45% associated with carboxymethylcellulose compared with isolated use of preservative-free artificial tears. A randomized double-masked study will include 60 patients divided into two groups: Group 1: using a formulation of ketorolac tromethamine 0.45% associated with carboxymethylcellulose (Acular CMC®, Allergan, Irvine, USA) and Group 0: using artificial tears (Optive UD®, Allergan, Irvine, USA), both drugs without preservatives.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Conjunctivitis, Viral
Intervention  ICMJE
  • Drug: Ketorolac trometamol 0.45% with carboxymethylcellulose
    Other Name: Acular CMC®, Allergan, Irvine, USA
  • Drug: Preservative free artificial tear
    Other Name: Optive UD®, Allergan, Irvine, USA
Study Arms  ICMJE
  • Experimental: Ketorolac trometamol 0.45%
    Ketorolac trometamol 0.45% associated with carboxymethylcellulose eye drops (Acular CMC®, Allergan, Irvine, USA) qid for 7 days.
    Intervention: Drug: Ketorolac trometamol 0.45% with carboxymethylcellulose
  • Placebo Comparator: Artificial tears
    Preservative free artificial tears (Optive UD®, Allergan, Irvine, USA) qid for 7 days.
    Intervention: Drug: Preservative free artificial tear
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 7, 2015)
50
Original Estimated Enrollment  ICMJE
 (submitted: February 25, 2013)
60
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Acute conjunctivitis (unilateral or bilateral) for less than two weeks,
  • Signs and symptoms consistent with viral conjunctivitis and at least one of the following: preauricular lymphadenopathy, upper tract respiratory infection or recent contact with someone with conjunctivitis

Exclusion Criteria:

  • pregnant women
  • allergies to non-steroidal anti-inflammatories
  • history of seasonal allergic conjunctivitis
  • contact lens wearers
  • history of ocular herpes infection
  • blepharitis
  • severe dry eye
  • purulent discharge
  • defects in the corneal epithelium
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01799863
Other Study ID Numbers  ICMJE FAV011_12
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fundação Altino Ventura
Study Sponsor  ICMJE Fundação Altino Ventura
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Adriana Falcão, MD Fundação Altino Ventura
Study Director: Lucio Maranhão, MD Fundação Altino Ventura
PRS Account Fundação Altino Ventura
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP