CataractPhase 3NCT00332774
Nevanac 3-Month Safety Study With QID Dosing
A Phase 3 study testing Nepafenac ophthalmic solution 0.1% and Ketorolac Tromethamine ophthalmic solution 0.4% in people with Cataract, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety of Nevanac 0.1% compared to Acular LS 0.4% and Vehicle in patients treated before cataract surgery and for approximately 90 days following surgery. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Nepafenac ophthalmic solution 0.1% and Ketorolac Tromethamine ophthalmic solution 0.4%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 149 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Dec 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients of any race or sex ages 10 years or older undergoing cataract extraction with planned implantation of a posterior chamber intraocular lens.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Under 10
- Other protocol-defined exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Alcon for Trial Locations
Fort Worth, Texas, 76134
About this study
Official title: A 3-Month Clinical Safety Comparison of Nevanac 0.1% to Acular LS 0.4% and Vehicle Following Cataract Surgery
The purpose of this study is to determine the safety of Nevanac 0.1% compared to Acular LS 0.4% and Vehicle in patients treated before cataract surgery and for approximately 90 days following surgery.
- Conditions
- Cataract
- Being tested
- Nepafenac ophthalmic solution 0.1%, Ketorolac Tromethamine ophthalmic solution 0.4%, Nepafenac ophthalmic suspension vehicle
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nepafenac ophthalmic solution 0.1%Drug
1 drop 4 times daily for 90 days
Ketorolac Tromethamine ophthalmic solution 0.4%Drug
1 drop 4 times daily for 90 days
Nepafenac ophthalmic suspension vehicleOther
Also called 1 drop 4 times daily for 14 days after surgery
| Study group | Role | What they receive |
|---|---|---|
| Nevanac | Experimental | Not described Receives: Drug: Nepafenac ophthalmic solution 0.1% |
| Acular | Active comparator | Not described Receives: Drug: Ketorolac Tromethamine ophthalmic solution 0.4% |
| Vehicle | Placebo comparator | Not described Receives: Other: Nepafenac ophthalmic suspension vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular thickness
Secondary outcomes (1)
contrast sensitivity, corneal staining, VA, IOP, slit-lamp parameters, fundus parameters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2006 (estimated)
- Study startFeb 2006
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Lane, Study director, Medical Monitor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00332774
- Sponsor's protocol ID
- C-05-20
- Status last verified
- Mar 2012
- First submitted
- 1 Jun 2006
- Last updated
- 5 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3-Month Clinical Safety Comparison of Nevanac 0.1% to Acular LS 0.4% and Vehicle Following Cataract Surgery
- ClinicalTrials.gov ID
- NCT00332774
- Acronym / sponsor ID
- C-05-20
- Conditions
- Cataract
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 2 Jun 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.
The purpose of this study is to determine the safety of Nevanac 0.1% compared to Acular LS 0.4% and Vehicle in patients treated before cataract surgery and for approximately 90 days following surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nevanac | Experimental | Drug: Nepafenac ophthalmic solution 0.1% |
| Acular | Active comparator | Drug: Ketorolac Tromethamine ophthalmic solution 0.4% |
| Vehicle | Placebo comparator | Other: Nepafenac ophthalmic suspension vehicle |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of any race or sex ages 10 years or older undergoing cataract extraction with planned implantation of a posterior chamber intraocular lens.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (2 listed)
- Under 10
- 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 ophthalmic solution 0.1%1 drop 4 times daily for 90 days | Drug | Nevanac |
| Ketorolac Tromethamine ophthalmic solution 0.4%1 drop 4 times daily for 90 days | Drug | Acular |
| Nepafenac ophthalmic suspension vehicleAlso: 1 drop 4 times daily for 14 days after surgery | Other | Vehicle |
Primary outcome
Macular thickness
1 secondary outcome
contrast sensitivity, corneal staining, VA, IOP, slit-lamp parameters, fundus parameters
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 5 Mar 2012.
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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.
Stephen Lane study director
Medical Monitor
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 ophthalmic solution 0.1% and Ketorolac Tromethamine ophthalmic solution 0.4% in people with Cataract, run by Alcon Research at 1 site in United States.
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 5 Mar 2012. 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 United States. 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?
Macular thickness. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2012.