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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

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.

Condition or disease Intervention/treatment Phase
Conjunctivitis, Viral Drug: Ketorolac trometamol 0.45% with carboxymethylcellulose Drug: Preservative free artificial tear Phase 2 Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Artificial Tears Versus Preservative Free Ketorolac Trometamol 0.45% for Treatment of Acute Viral Conjunctivitis
Study Start Date : June 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye Tears

Arm Intervention/treatment
Experimental: Ketorolac trometamol 0.45%
Ketorolac trometamol 0.45% associated with carboxymethylcellulose eye drops (Acular CMC®, Allergan, Irvine, USA) qid for 7 days.
Drug: Ketorolac trometamol 0.45% with carboxymethylcellulose
Other Name: Acular CMC®, Allergan, Irvine, USA

Placebo Comparator: Artificial tears
Preservative free artificial tears (Optive UD®, Allergan, Irvine, USA) qid for 7 days.
Drug: Preservative free artificial tear
Other Name: Optive UD®, Allergan, Irvine, USA




Primary Outcome Measures :
  1. 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).

  2. 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)



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01799863


Locations
Brazil
Fundação Altino Ventura
Recife, Pernambuco, Brazil, 50070040
Sponsors and Collaborators
Fundação Altino Ventura
Investigators
Principal Investigator: Adriana Falcão, MD Fundação Altino Ventura
Study Director: Lucio Maranhão, MD Fundação Altino Ventura

Publications:
Responsible Party: Fundação Altino Ventura
ClinicalTrials.gov Identifier: NCT01799863     History of Changes
Other Study ID Numbers: FAV011_12
First Posted: February 27, 2013    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: April 2015

Keywords provided by Fundação Altino Ventura:
Conjunctivitis, Viral
Ketorolac
Artificial tears

Additional relevant MeSH terms:
Ketorolac
Ketorolac Tromethamine
Conjunctivitis
Conjunctivitis, Viral
Conjunctival Diseases
Eye Diseases
Eye Infections, Viral
Virus Diseases
Eye Infections
Lubricant Eye Drops
Carboxymethylcellulose Sodium
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Ophthalmic Solutions
Pharmaceutical Solutions
Laxatives
Gastrointestinal Agents