- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01799863
Artificial Tears Versus Preservative Free Ketorolac Trometamol 0.45% for Acute Viral Conjunctivitis
April 7, 2015 updated by: Fundação Altino Ventura
Artificial Tears Versus Preservative Free Ketorolac Trometamol 0.45% for Treatment of Acute Viral Conjunctivitis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pernambuco
-
Recife, Pernambuco, Brazil, 50070040
- Fundação Altino Ventura
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ketorolac trometamol 0.45%
Ketorolac trometamol 0.45% associated with carboxymethylcellulose eye drops (Acular CMC®, Allergan, Irvine, USA) qid for 7 days.
|
Other Names:
|
Placebo Comparator: Artificial tears
Preservative free artificial tears (Optive UD®, Allergan, Irvine, USA) qid for 7 days.
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in ocular symptoms from baseline to treatment day 7
Time Frame: 7 days
|
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
|
Change in ocular signs from baseline to treatment day 7
Time Frame: 7 days
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Adriana Falcão, MD, Fundação Altino Ventura
- Study Director: Lucio Maranhão, MD, Fundação Altino Ventura
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
February 22, 2013
First Submitted That Met QC Criteria
February 25, 2013
First Posted (Estimate)
February 27, 2013
Study Record Updates
Last Update Posted (Estimate)
April 8, 2015
Last Update Submitted That Met QC Criteria
April 7, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Virus Diseases
- Infections
- Eye Diseases
- Conjunctival Diseases
- Eye Infections
- Eye Infections, Viral
- Conjunctivitis
- Conjunctivitis, Viral
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Gastrointestinal Agents
- Pharmaceutical Solutions
- Laxatives
- Ophthalmic Solutions
- Ketorolac
- Lubricant Eye Drops
- Ketorolac Tromethamine
- Carboxymethylcellulose Sodium
Other Study ID Numbers
- FAV011_12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Conjunctivitis, Viral
-
ShireCompletedAcute Viral ConjunctivitisUnited States, Brazil
-
University of MiamiNovaBay Pharmaceuticals, Inc.Terminated
-
NicOxCompleted
-
University of Campinas, BrazilCompletedViral ConjunctivitisBrazil
-
Mahidol UniversityCompleted
-
Adenovir Pharma ABTFS Trial Form SupportCompletedViral ConjunctivitisGermany, Poland, Sweden
Clinical Trials on Ketorolac trometamol 0.45% with carboxymethylcellulose
-
Chulalongkorn UniversityCompleted
-
The Hospital for Sick ChildrenCompleted
-
Bucci Laser Vision InstituteAllerganCompletedPost Operative Anterior Chamber Inflammation (Flare)United States
-
Washington University School of MedicineRecruiting
-
University of MalayaCompletedDiabetes Mellitus | Cystoid Macular Edema, PostoperativeMalaysia
-
Frank A. Bucci, Jr., M.D.AllerganCompleted
-
Vanderbilt UniversityWithdrawnInflammationUnited States
-
Fundación Nacional para la Enseñanza y la Investigación...Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUnknown
-
Institut Claudius RegaudAdvanced Accelerator ApplicationsRecruiting
-
University of Colorado, DenverTerminatedOpen Angle GlaucomaUnited States