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

Phase 2

Completed

• Conditions: Conjunctivitis, Viral
• Interventions: Drug: Ketorolac trometamol 0.45% with carboxymethylcellulose; Drug: Preservative free artificial tear

• Registration Number: NCT01799863
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-06
• Study First Submitted: 2013-02-22
• Study First Submitted QC: 2013-02-25
• Study First Posted: 2013-02-27
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketorolac trometamol 0.45%	Ketorolac trometamol 0.45% with carboxymethylcellulose	Ketorolac trometamol 0.45% associated with carboxymethylcellulose eye drops (Acular CMC®, Allergan, Irvine, USA) qid for 7 days.
Artificial tears	Preservative free artificial tear	Preservative free artificial tears (Optive UD®, Allergan, Irvine, USA) qid for 7 days.

Primary Outcome Measures

Name	Time	Method
Change in ocular symptoms from baseline to treatment day 7	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	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)

Trial Locations

Locations (1)

Fundação Altino Ventura; 🇧🇷 Recife, Pernambuco, Brazil