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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-03-31

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.

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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.

Conditions

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Conjunctivitis, Viral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Ketorolac trometamol 0.45%

Ketorolac trometamol 0.45% associated with carboxymethylcellulose eye drops (Acular CMC®, Allergan, Irvine, USA) qid for 7 days.

Group Type EXPERIMENTAL

Ketorolac trometamol 0.45% with carboxymethylcellulose

Intervention Type DRUG

Artificial tears

Preservative free artificial tears (Optive UD®, Allergan, Irvine, USA) qid for 7 days.

Group Type PLACEBO_COMPARATOR

Preservative free artificial tear

Intervention Type DRUG

Interventions

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Ketorolac trometamol 0.45% with carboxymethylcellulose

Intervention Type DRUG

Preservative free artificial tear

Intervention Type DRUG

Other Intervention Names

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Acular CMC®, Allergan, Irvine, USA Optive UD®, Allergan, Irvine, USA

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No