CataractsPhase 3NCT00405730
Nepafenac 0.1% Eye Drops, Suspension Compared to Ketorolac Trometamol 0.5% Eye Drops, Solution and Placebo
A Phase 3 study testing Nepafenac 1mg/ml eye drops, suspension and Ketorolac Trometamol 5 mg/ml eye drops, solution in people with Cataracts, run by Alcon Research at 1 site in France.
Trial summary
To evaluate the safety and efficacy of Nepafenac 1 mg/ml Eye Drops, Suspension, compared to Placebo and Ketorolac Trometamol 5 mg/ml Eye Drops, Solution for the prevention and treatment of ocular inflammation and ocular pain after cataract extraction with IOL implantation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataracts
- What is being tested?
- Nepafenac 1mg/ml eye drops, suspension and Ketorolac Trometamol 5 mg/ml eye drops, solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 227 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2005to Jul 2006
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (18 years or older) of any race and either sex, requiring cataract extraction with planned implantation of a posterior chamber intraocular lens.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Under 18.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nepafenac 0.1% Eye Drops, Suspension Compared to Ketorolac Trometamol 0.5% Eye Drops, Solution and Placebo (Nepafenac Vehicle) for the Prevention and Treatment of Ocular Inflammation and Ocular Pain Associated With Cataract Surgery: European Study
To evaluate the safety and efficacy of Nepafenac 1 mg/ml Eye Drops, Suspension, compared to Placebo and Ketorolac Trometamol 5 mg/ml Eye Drops, Solution for the prevention and treatment of ocular inflammation and ocular pain after cataract extraction with IOL implantation
- Conditions
- Cataracts
- Being tested
- Nepafenac 1mg/ml eye drops, suspension, Ketorolac Trometamol 5 mg/ml eye drops, solution, Nepafenac vehicle eye drops
- Keywords
- Cataracts
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nepafenac 1mg/ml eye drops, suspensionDrug
One drop in the study eye 3 times daily for 23 days
Ketorolac Trometamol 5 mg/ml eye drops, solutionDrug
One drop in the study eye 3 times daily for 23 days
Nepafenac vehicle eye dropsOther
One drop in the study eye 3 times daily for 23 days
| Study group | Role | What they receive |
|---|---|---|
| Nepafenac | Experimental | One drop in the study eye 3 times daily for 23 days Receives: Drug: Nepafenac 1mg/ml eye drops, suspension |
| Ketorolac Trometamol | Active comparator | One drop in the study eye 3 times daily for 23 days Receives: Drug: Ketorolac Trometamol 5 mg/ml eye drops, solution |
| Nepafenac Vehicle | Placebo comparator | One drop in the study eye 3 times daily for 23 days Receives: Other: Nepafenac vehicle eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients with Day 14 Cure
Cure is defined as aqueous cells score = 0 and aqueous cells score = 0 at Day 14.
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2006 (estimated)
- Study startNov 2005
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractsStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00405730
- Sponsor's protocol ID
- C-04-65
- Other IDs
- 2005-002647-35, 2005
- Status last verified
- Apr 2012
- First submitted
- 29 Nov 2006
- Last updated
- 18 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Nardi M, Lobo C, Bereczki A, Cano J, Zagato E, Potts S, Sullins G, Notivol R. Analgesic and anti-inflammatory effectiveness of nepafenac 0.1% for cataract surgery. Clin Ophthalmol. 2007 Dec;1(4):527-33.
PubMed 19668532
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nepafenac 0.1% Eye Drops, Suspension Compared to Ketorolac Trometamol 0.5% Eye Drops, Solution and Placebo (Nepafenac Vehicle) for the Prevention and Treatment of Ocular Inflammation and Ocular Pain Associated With Cataract Surgery: European Study
- ClinicalTrials.gov ID
- NCT00405730
- Acronym / sponsor ID
- C-04-65
- Conditions
- Cataracts
- Keywords
- Cataracts
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 30 Nov 2006 (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.
To evaluate the safety and efficacy of Nepafenac 1 mg/ml Eye Drops, Suspension, compared to Placebo and Ketorolac Trometamol 5 mg/ml Eye Drops, Solution for the prevention and treatment of ocular inflammation and ocular pain after cataract extraction with IOL implantation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nepafenac | Experimental | Drug: Nepafenac 1mg/ml eye drops, suspensionOne drop in the study eye 3 times daily for 23 days |
| Ketorolac Trometamol | Active comparator | Drug: Ketorolac Trometamol 5 mg/ml eye drops, solutionOne drop in the study eye 3 times daily for 23 days |
| Nepafenac Vehicle | Placebo comparator | Other: Nepafenac vehicle eye dropsOne drop in the study eye 3 times daily for 23 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients (18 years or older) of any race and either sex, requiring cataract extraction with planned implantation of a posterior chamber intraocular lens.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (2 listed)
- Under 18.
- Other protocol-defined exclusion criteria may apply.
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 |
|---|---|---|
| Nepafenac 1mg/ml eye drops, suspensionOne drop in the study eye 3 times daily for 23 days | Drug | Nepafenac |
| Ketorolac Trometamol 5 mg/ml eye drops, solutionOne drop in the study eye 3 times daily for 23 days | Drug | Ketorolac Trometamol |
| Nepafenac vehicle eye dropsOne drop in the study eye 3 times daily for 23 days | Other | Nepafenac Vehicle |
Primary outcome
Percentage of Patients with Day 14 Cure
Time frame: Day 14
Cure is defined as aqueous cells score = 0 and aqueous cells score = 0 at Day 14.
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 18 Nov 2016.
- Results publication: PubMed 19668532Nardi M, Lobo C, Bereczki A, Cano J, Zagato E, Potts S, Sullins G, Notivol R. Analgesic and anti-inflammatory effectiveness of nepafenac 0.1% for cataract surgery. Clin Ophthalmol. 2007 Dec;1(4):527-33.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nepafenac 1mg/ml eye drops, suspension and Ketorolac Trometamol 5 mg/ml eye drops, solution in people with Cataracts, run by Alcon Research at 1 site in France.
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 2 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 18 Nov 2016. 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 France. 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 phase mean?
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?
Percentage of Patients with Day 14 Cure (time frame: Day 14). 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 NCT00405730, which also lists 1 linked publication.
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 18 Nov 2016.