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

Conjunctivitis, Viral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01799863
• Other study ID #: FAV011_12
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 22, 2013
• Last updated: April 7, 2015
• Start date: June 2012
• Est. completion date: March 2013

Study information

• Verified date: April 2015
• Source: Fundação Altino Ventura
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Conjunctivitis
• Conjunctivitis, Viral

Intervention

Drug:
• Ketorolac trometamol 0.45% with carboxymethylcellulose

• Preservative free artificial tear

Locations

Country	Name	City	State
Brazil	Fundação Altino Ventura	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Fundação Altino Ventura

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. — View 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. Epub 2006 Mar 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No