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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Conjunctivitis, Viral

Intervention / Treatment
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* Drug: Ketorolac trometamol 0.45% with carboxymethylcellulose
* Drug: Preservative free artificial tear


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketorolac trometamol 0.45%<br>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<br> <br> * Other names: Acular CMC®, Allergan, Irvine, USA;|
| Placebo Comparator: Artificial tears<br>Preservative free artificial tears (Optive UD®, Allergan, Irvine, USA) qid for 7 days. | Drug: Preservative free artificial tear<br> <br> * Other names: Optive UD®, Allergan, Irvine, USA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ocular symptoms from baseline to treatment day 7 | 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). | 7 days | 
| Change in ocular signs from baseline to treatment day 7 | 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) | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Conjunctivitis, Viral, Artificial tears, Ketorolac