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

Fundação Altino Ventura

Status and phase: Completed; Phase 3; Phase 2

Conditions: Conjunctivitis, Viral

Treatments: Drug: Preservative free artificial tear; Drug: Ketorolac trometamol 0.45% with carboxymethylcellulose

Study type: Interventional

Funder types: Other

Identifiers

NCT01799863

FAV011_12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Ketorolac trometamol 0.45%

Experimental group

Description:

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

Treatment:

Drug: Ketorolac trometamol 0.45% with carboxymethylcellulose

Artificial tears

Placebo Comparator group

Description:

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

Treatment:

Drug: Preservative free artificial tear