Artificial Tears Versus Preservative Free Ketorolac Trometamol 0.45% for Acute Viral Conjunctivitis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01799863|
Recruitment Status : Completed
First Posted : February 27, 2013
Last Update Posted : April 8, 2015
|Condition or disease||Intervention/treatment||Phase|
|Conjunctivitis, Viral||Drug: Ketorolac trometamol 0.45% with carboxymethylcellulose Drug: Preservative free artificial tear||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Artificial Tears Versus Preservative Free Ketorolac Trometamol 0.45% for Treatment of Acute Viral Conjunctivitis|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
Experimental: Ketorolac trometamol 0.45%
Ketorolac trometamol 0.45% associated with carboxymethylcellulose eye drops (Acular CMC®, Allergan, Irvine, USA) qid for 7 days.
Drug: Ketorolac trometamol 0.45% with carboxymethylcellulose
Other Name: Acular CMC®, Allergan, Irvine, USA
Placebo Comparator: Artificial tears
Preservative free artificial tears (Optive UD®, Allergan, Irvine, USA) qid for 7 days.
Drug: Preservative free artificial tear
Other Name: Optive UD®, Allergan, Irvine, USA
- 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).
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799863
|Fundação Altino Ventura|
|Recife, Pernambuco, Brazil, 50070040|
|Principal Investigator:||Adriana Falcão, MD||Fundação Altino Ventura|
|Study Director:||Lucio Maranhão, MD||Fundação Altino Ventura|