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

Primary Purpose

Conjunctivitis, Viral

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Ketorolac trometamol 0.45% with carboxymethylcellulose
Preservative free artificial tear
Sponsored by
Fundação Altino Ventura
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Conjunctivitis, Viral focused on measuring Conjunctivitis, Viral, Ketorolac, Artificial tears

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Fundação Altino Ventura

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ketorolac trometamol 0.45%

Artificial tears

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).
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)

Secondary Outcome Measures

Full Information

First Posted
February 22, 2013
Last Updated
April 7, 2015
Sponsor
Fundação Altino Ventura
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1. Study Identification

Unique Protocol Identification Number
NCT01799863
Brief Title
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

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundação Altino Ventura

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conjunctivitis, Viral
Keywords
Conjunctivitis, Viral, Ketorolac, Artificial tears

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketorolac trometamol 0.45%
Arm Type
Experimental
Arm Description
Ketorolac trometamol 0.45% associated with carboxymethylcellulose eye drops (Acular CMC®, Allergan, Irvine, USA) qid for 7 days.
Arm Title
Artificial tears
Arm Type
Placebo Comparator
Arm Description
Preservative free artificial tears (Optive UD®, Allergan, Irvine, USA) qid for 7 days.
Intervention Type
Drug
Intervention Name(s)
Ketorolac trometamol 0.45% with carboxymethylcellulose
Other Intervention Name(s)
Acular CMC®, Allergan, Irvine, USA
Intervention Type
Drug
Intervention Name(s)
Preservative free artificial tear
Other Intervention Name(s)
Optive UD®, Allergan, Irvine, USA
Primary Outcome Measure Information:
Title
Change in ocular symptoms from baseline to treatment day 7
Description
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).
Time Frame
7 days
Title
Change in ocular signs from baseline to treatment day 7
Description
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)
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriana Falcão, MD
Organizational Affiliation
Fundação Altino Ventura
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lucio Maranhão, MD
Organizational Affiliation
Fundação Altino Ventura
Official's Role
Study Director
Facility Information:
Facility Name
Fundação Altino Ventura
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50070040
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
10919900
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.
Results Reference
background
PubMed Identifier
16527227
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.
Results Reference
background

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

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