CataractPhase 3NCT01426854

Nepafenac Compared to Placebo for Ocular Pain and Inflammation

A Phase 3 study testing Nepafenac Ophthalmic Suspension, 0.1% in people with Cataract, run by Alcon Research at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study was to demonstrate that Nepafenac Ophthalmic Suspension, 0.1% is superior to Nepafenac Vehicle (placebo) for the prevention and treatment of ocular inflammation and pain associated with cataract surgery in Chinese subjects. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cataract
What is being tested?: Nepafenac Ophthalmic Suspension, 0.1%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 260 participants
Where: 1 siteChina
Study dates: Jul 2011to Apr 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Adult Chinese subjects, 18 years of age or older, of either sex who have a cataract, and are expected to undergo cataract extraction with the implantation of a posterior chamber intraocular lens;
Study eye of subjects, who in the opinion of the Investigator, will have improvement in best-corrected visual acuity after surgery;
Subjects should be able to understand and sign an informed consent that has been approved by an Independent Ethics Committee;
Other protocol-defined inclusion criteria may apply.

Who cannot join

Use of topical ocular or systemic steroids within 14 days prior to surgery;
Use of topical ocular or systemic non-steroidal anti-inflammatory drugs within 7 days of surgery, except an allowed daily dose of baby aspirin (81 mg);
Subjects planning to have cataract surgery in their fellow, non-study eye prior to the 14 day postoperative study visit;
Any intraocular inflammation or ocular pain greater than Grade 0 in the study eye that is present during the baseline slit-lamp exam;
Women of childbearing potential (those who are not surgically sterilized or post menopausal) may not participate in the study if any of the following conditions exist:
they are breast feeding;

Show all 29Show fewer

they have a positive urine pregnancy test at baseline;
they are not willing to undergo a urine pregnancy test upon exiting the study;
they intend to become pregnant during the duration of the study; or,
they do not agree to using adequate birth control methods for the duration of the study.
Any abnormality that prevents reliable tonometry;
Planned multiple procedures during cataract/IOL implantation surgery;
Lens pseudoexfoliation syndrome with glaucoma or zonular compromise;
Previous ocular trauma to the operative eye;
A history of chronic or recurrent inflammatory eye disease;
Ocular infection or ocular pain;
Proliferative diabetic retinopathy;
Uncontrolled diabetes mellitus;
Congenital ocular anomaly;
Iris atrophy in the operative eye;
A nonfunctional fellow eye;
Use of an investigational intraocular lens;
Participation in any other clinical study within 30 days before surgery;
Known or suspected allergy or hypersensitivity to non-steroidal anti-inflammatory agents, or to any component of the study medication;
Subjects with known bleeding tendencies, or who are receiving medications that may prolong bleeding time, may be enrolled at the physician's discretion; continuation of previous therapy for these subjects will be left to the judgment of the physician;
The fellow eye of an individual currently or previously enrolled in the study;
Subjects using a topical ophthalmic prostaglandin;
Subjects, who in the opinion of the investigator, might be at increased risk of complications from topical NSAIDs;
Other protocol-defined exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

China1 site

Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: Clinical Evaluation of Safety and Efficacy of Nepafenac Ophthalmic Suspension, 0.1% Compared to Placebo for the Prevention and Treatment of Ocular Inflammation and Pain Associated With Cataract Surgery in Adult Chinese Subjects

Conditions: Cataract
Being tested: Nepafenac Ophthalmic Suspension, 0.1%, Nepafenac Vehicle Ophthalmic Solution
Keywords: Cataract Surgery, Anti-ocular Inflammation, Anti-ocular Pain
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 Suspension, 0.1%Drug
Topical ocular administration
Nepafenac Vehicle Ophthalmic SolutionOther
Inactive ingredients used as placebo; topical ocular administration

Study groups in NCT01426854
Study group	Role	What they receive
Nepafenac	Active comparator	Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery. Receives: Drug: Nepafenac Ophthalmic Suspension, 0.1%
Placebo	Placebo comparator	Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery. Receives: Other: Nepafenac Vehicle Ophthalmic Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Subjects With Clinical Cure at Day 14
Ocular inflammation was assessed by the Investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (>30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). To be considered cured, the patient must have had a score of 0 for both aqueous cells and aqueous flare. The proportion of subjects with a clinical cure is reported as percentage.
Measured: Day 14 postoperative

Secondary outcomes (1)

Proportion of Subjects Who Were Pain-Free at All Postoperative Visits
Ocular pain is defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. The Investigator scored ocular pain based on the description of pain by the subject. Pain was scored on a 6-unit scale ranging from 0 (none, absence of positive sensation) to 5 (severe, subject reports intense ocular, periocular or radiating pain requiring prescription analgesic). To be considered pain-free at all post operative visits, the patient must have had a score of 0 at Days 1, 3, 7, and 14 and any unscheduled visit. The proportion of subjects who were pain-free at all post-operative visits is reported as percentage.
Measured: Up to Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2011Apr 2012

First posted1 Sep 2011 (estimated)
Study startJul 2011
Primary completionApr 2012
Study completionApr 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CataractStudies 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: Single blind
Who is masked: Outcomes assessor
Enrolment: 260 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01426854
Sponsor's protocol ID: C-10-026
Status last verified: May 2013
First submitted: 30 Aug 2011
Last updated: 13 May 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cataract trials

Study at a glance

From the registry record, last updated by the sponsor on 13 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of Safety and Efficacy of Nepafenac Ophthalmic Suspension, 0.1% Compared to Placebo for the Prevention and Treatment of Ocular Inflammation and Pain Associated With Cataract Surgery in Adult Chinese Subjects
ClinicalTrials.gov ID: NCT01426854
Acronym / sponsor ID: C-10-026
Conditions: Cataract
Keywords: Cataract Surgery, Anti-ocular Inflammation, Anti-ocular Pain
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 260 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Jul 2011
Primary completion: Apr 2012 (actual)
Study completion: Apr 2012 (actual)
First posted: 1 Sep 2011 (estimated)
Results: Posted 13 May 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Nepafenac	Active comparator	Drug: Nepafenac Ophthalmic Suspension, 0.1%Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
Placebo	Placebo comparator	Other: Nepafenac Vehicle Ophthalmic SolutionNepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Adult Chinese subjects, 18 years of age or older, of either sex who have a cataract, and are expected to undergo cataract extraction with the implantation of a posterior chamber intraocular lens;
Study eye of subjects, who in the opinion of the Investigator, will have improvement in best-corrected visual acuity after surgery;
Subjects should be able to understand and sign an informed consent that has been approved by an Independent Ethics Committee;
Other protocol-defined inclusion criteria may apply.

Key exclusion criteria (29 listed)

Use of topical ocular or systemic steroids within 14 days prior to surgery;
Use of topical ocular or systemic non-steroidal anti-inflammatory drugs within 7 days of surgery, except an allowed daily dose of baby aspirin (81 mg);
Subjects planning to have cataract surgery in their fellow, non-study eye prior to the 14 day postoperative study visit;
Any intraocular inflammation or ocular pain greater than Grade 0 in the study eye that is present during the baseline slit-lamp exam;
Women of childbearing potential (those who are not surgically sterilized or post menopausal) may not participate in the study if any of the following conditions exist:

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 Suspension, 0.1%Topical ocular administration	Drug	Nepafenac
Nepafenac Vehicle Ophthalmic SolutionInactive ingredients used as placebo; topical ocular administration	Other	Placebo

Primary outcome

Proportion of Subjects With Clinical Cure at Day 14
Time frame: Day 14 postoperative
Ocular inflammation was assessed by the Investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (>30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). To be considered cured, the patient must have had a score of 0 for both aqueous cells and aqueous flare. The proportion of subjects with a clinical cure is reported as percentage.

1 secondary outcome

Proportion of Subjects Who Were Pain-Free at All Postoperative Visits
Time frame: Up to Day 14

Results and safety

Results posted to the registry on 13 May 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nepafenac	131	119
Placebo	129	98

Primary outcome: Proportion of Subjects With Clinical Cure at Day 14

Time frame: Day 14 postoperative. Number. Unit: Percentage of subjects

Measure	Nepafenac n = 122	Placebo n = 122
Value	80.3	39.3

Nepafenac vs Placebo: p <0.0001, Cochran-Mantel-Haenszel

Population analysed: Intent-to-treat: All randomized subjects who completed cataract/IOL implant surgery and returned for at least one postoperative primary efficacy assessment.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected for the duration of the study. Individual adverse events were recorded from the start of study treatment. At each visit, after the subject spontaneously mentioned any problems, the study staff inquired about adverse events.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nepafenac	0 of 125 (0%)	0 of 125 (0%)	Not reported
Placebo	1 of 123 (0.8%)	0 of 123 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Mandy Ye, Director study director

Alcon (China) Ophthalmic Product Co., Ltd.

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 Suspension, 0.1% in people with Cataract, run by Alcon Research at 1 site in China.

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 4 inclusion and 29 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 13 May 2013. 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 China. 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?

Yes. Results are posted in the registry (first posted 13 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Proportion of Subjects With Clinical Cure at Day 14 (time frame: Day 14 postoperative). 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 NCT01426854.

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 13 May 2013.