Conjunctivitis, ViralPhase 2/3NCT01799863
Artificial Tears Versus Preservative Free Ketorolac Trometamol 0.45% for Acute Viral Conjunctivitis
A Phase 2/3 study testing Ketorolac trometamol 0.45% with carboxymethylcellulose and Preservative free artificial tear in people with Conjunctivitis, Viral, run by Fundação Altino Ventura at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Conjunctivitis, Viral
- What is being tested?
- Ketorolac trometamol 0.45% with carboxymethylcellulose and Preservative free artificial tear
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2012to Mar 2013
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnant women
- allergies to non-steroidal anti-inflammatories
- history of seasonal allergic conjunctivitis
- contact lens wearers
- history of ocular herpes infection
- blepharitis
Show all 9Show fewer
- severe dry eye
- purulent discharge
- defects in the corneal epithelium
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Conjunctivitis, Viral
- Being tested
- Ketorolac trometamol 0.45% with carboxymethylcellulose, Preservative free artificial tear
- Keywords
- Conjunctivitis, Viral, Ketorolac, Artificial tears
- Medical subject headings
- Conjunctivitis, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac trometamol 0.45% with carboxymethylcelluloseDrug
Also called Acular CMC®, Allergan, Irvine, USA
Preservative free artificial tearDrug
Also called Optive UD®, Allergan, Irvine, USA
| Study group | Role | What they receive |
|---|---|---|
| Ketorolac trometamol 0.45% | Experimental | Ketorolac trometamol 0.45% associated with carboxymethylcellulose eye drops (Acular CMC®, Allergan, Irvine, USA) qid for 7 days. Receives: Drug: Ketorolac trometamol 0.45% with carboxymethylcellulose |
| Artificial tears | Placebo comparator | Preservative free artificial tears (Optive UD®, Allergan, Irvine, USA) qid for 7 days. Receives: Drug: Preservative free artificial tear |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2013 (estimated)
- Study startJun 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Conjunctivitis, ViralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundação Altino Ventura
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adriana Falcão, MD, Principal investigator, Fundação Altino VenturaLucio Maranhão, MD, Study director, Fundação Altino Ventura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799863
- Sponsor's protocol ID
- FAV011_12
- Status last verified
- Apr 2015
- First submitted
- 22 Feb 2013
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 10919900Toker 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.
PubMed 16527227
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Tears Versus Preservative Free Ketorolac Trometamol 0.45% for Treatment of Acute Viral Conjunctivitis
- ClinicalTrials.gov ID
- NCT01799863
- Acronym / sponsor ID
- FAV011_12
- Conditions
- Conjunctivitis, Viral
- Keywords
- Conjunctivitis, Viral, Ketorolac, Artificial tears
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fundação Altino VenturaUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 27 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketorolac trometamol 0.45% | Experimental | Drug: Ketorolac trometamol 0.45% with carboxymethylcelluloseKetorolac trometamol 0.45% associated with carboxymethylcellulose eye drops (Acular CMC®, Allergan, Irvine, USA) qid for 7 days. |
| Artificial tears | Placebo comparator | Drug: Preservative free artificial tearPreservative free artificial tears (Optive UD®, Allergan, Irvine, USA) qid for 7 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- pregnant women
- allergies to non-steroidal anti-inflammatories
- history of seasonal allergic conjunctivitis
- contact lens wearers
- history of ocular herpes infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketorolac trometamol 0.45% with carboxymethylcelluloseAlso: Acular CMC®, Allergan, Irvine, USA | Drug | Ketorolac trometamol 0.45% |
| Preservative free artificial tearAlso: Optive UD®, Allergan, Irvine, USA | Drug | Artificial tears |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
- Background: PubMed 10919900Shiuey 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.
- Background: PubMed 16527227Toker 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adriana Falcão, MD principal investigator
Fundação Altino Ventura
Lucio Maranhão, MD study director
Fundação Altino Ventura
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ketorolac trometamol 0.45% with carboxymethylcellulose and Preservative free artificial tear in people with Conjunctivitis, Viral, run by Fundação Altino Ventura at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ocular symptoms from baseline to treatment day 7 (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01799863, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2015.