Clinical trial NCT01799863: Artificial Tears Versus Preservative Free Ketorolac Trometamol 0.45% for Acute Viral Conjunctivitis
Official title: Artificial Tears Versus Preservative Free Ketorolac Trometamol 0.45% for Treatment of Acute Viral Conjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Conjunctivitis, Viral
Keywords: Conjunctivitis, Viral
Ketorolac
Artificial tears
Lead sponsor: Fundação Altino Ventura
Sponsor class: OTHER
First posted: 2013-02-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in ocular symptoms from baseline to treatment day 7
timeFrame: 7 days
measure: Change in ocular signs from baseline to treatment day 7
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Fundação Altino Ventura
state: Pernambuco
Study officials:
affiliation: Fundação Altino Ventura
name: Adriana Falcão, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundação Altino Ventura
name: Lucio Maranhão, MD
role: STUDY_DIRECTOR
References:
citation: Shiuey Y, Ambati BK, Adamis AP. A randomized, double-masked trial of topical ketorolac versus artificial tears for treatment of viral conjunctivitis. Ophthalmology. 2000 Aug;107(8):1512-7. doi: 10.1016/s0161-6420(00)00177-9.
citation: Toker MI, Erdem H, Erdogan H, Arici MK, Topalkara A, Arslan OS, Pahsa A. The effects of topical ketorolac and indomethacin on measles conjunctivitis: randomized controlled trial. Am J Ophthalmol. 2006 May;141(5):902-905. doi: 10.1016/j.ajo.2005.12.004. Epub 2006 Mar 9.