Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketorolac trometamol 0.45% | Experimental | Ketorolac trometamol 0.45% associated with carboxymethylcellulose eye drops (Acular CMC®, Allergan, Irvine, USA) qid for 7 days. |
|
| Artificial tears | Placebo Comparator | Preservative free artificial tears (Optive UD®, Allergan, Irvine, USA) qid for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac trometamol 0.45% with carboxymethylcellulose | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Adriana Falcão, MD | Fundação Altino Ventura | Principal Investigator |
| Lucio Maranhão, MD | Fundação Altino Ventura | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundação Altino Ventura | Recife | Pernambuco | 50070040 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10919900 | Background | 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. | |
| 16527227 | Background | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003236 | Conjunctivitis, Viral |
| ID | Term |
|---|---|
| D015828 | Eye Infections, Viral |
| D015817 | Eye Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D020910 | Ketorolac |
| D002266 | Carboxymethylcellulose Sodium |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Preservative free artificial tear | Drug |
|
|
| D003231 |
| Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006571 | Heterocyclic Compounds |
| D008747 | Methylcellulose |
| D002482 | Cellulose |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |