Artificial Tears Versus Preservative Free Ketorolac Trometamol 0.45% for Acute Viral Conjunctivitis
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ClinicalTrials.gov Identifier: NCT01799863 |
Recruitment Status :
Completed
First Posted : February 27, 2013
Last Update Posted : April 8, 2015
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Condition or disease | Intervention/treatment | Phase |
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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 |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
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Experimental: Ketorolac trometamol 0.45%
Ketorolac trometamol 0.45% associated with carboxymethylcellulose eye drops (Acular CMC®, Allergan, Irvine, USA) qid for 7 days.
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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.
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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)

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Brazil | |
Fundação Altino Ventura | |
Recife, Pernambuco, Brazil, 50070040 |
Principal Investigator: | Adriana Falcão, MD | Fundação Altino Ventura | |
Study Director: | Lucio Maranhão, MD | Fundação Altino Ventura |
Responsible Party: | Fundação Altino Ventura |
ClinicalTrials.gov Identifier: | NCT01799863 |
Other Study ID Numbers: |
FAV011_12 |
First Posted: | February 27, 2013 Key Record Dates |
Last Update Posted: | April 8, 2015 |
Last Verified: | April 2015 |
Conjunctivitis, Viral Ketorolac Artificial tears |
Conjunctivitis, Viral Conjunctivitis Conjunctival Diseases Eye Diseases Eye Infections, Viral Virus Diseases Eye Infections Ketorolac Ketorolac Tromethamine Carboxymethylcellulose Sodium Lubricant Eye Drops Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Ophthalmic Solutions Pharmaceutical Solutions Laxatives Gastrointestinal Agents |