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NCT Number: NCT01799863

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

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.

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Key information

Conditions

Conjunctivitis, Viral Conjunctival Diseases Conjunctivitis Eye Diseases Eye Infections Eye Infections, Viral Infections Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Fundação Altino Ventura

Recife, Pernambuco, 50070040, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketorolac trometamol 0.45% with carboxymethylcellulose

Drug

Other names: Acular CMC®, Allergan, Irvine, USA

Preservative free artificial tear

Drug

Other names: Optive UD®, Allergan, Irvine, USA

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Fundação Altino Ventura

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 27, 2013
Registry last updated
Apr 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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