Dry Eye SyndromePhase 3NCT01212471

A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease

A Phase 3 study testing Bromfenac Ophthalmic Solution A and Bromfenac Ophthalmic Solution B in people with Dry Eye Syndrome, run by Bausch & Lomb Incorporated at 1 site in United States.

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

A dose ranging study to evaluate safety and efficacy of bromfenac ophthalmic solution in dry eye disease. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dry Eye Syndrome
What is being tested?: Bromfenac Ophthalmic Solution A and Bromfenac Ophthalmic Solution B
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 840 participants
Where: 1 siteUnited States
Study dates: Sep 2010to Dec 2011
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

Be of either gender and any race 18 years or older

Who cannot join

Have a local or systemic disease that could interfere with the assessment of safety or efficacy or that is likely to result in early discontinuation from the study

Trial locations and contacts

1 site in 1 country.

United States1 site

ISTA Pharmaceuticals, Inc.
Irvine, California, 92618

Other trials in United States

About this study

A dose ranging study to evaluate safety and efficacy of bromfenac ophthalmic solution in dry eye disease.

Conditions: Dry Eye Syndrome
Being tested: Bromfenac Ophthalmic Solution A, Bromfenac Ophthalmic Solution B, Placebo Comparator
Keywords: Sign and symptoms of dry eye disease
Medical subject headings: Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bromfenac Ophthalmic Solution ADrug
sterile ophthalmic solution
Bromfenac Ophthalmic Solution BDrug
sterile ophthalmic solution
Placebo ComparatorDrug
sterile ophthalmic solution

Study groups in NCT01212471
Study group	Role	What they receive
Bromfenac Ophthalmic Solution A	Experimental	Bromfenac ophthalmic solution A Receives: Drug: Bromfenac Ophthalmic Solution A
Bromfenac Ophthalmic Solution B	Experimental	Bromfenac ophthalmic solution B Receives: Drug: Bromfenac Ophthalmic Solution B
Placebo Comparator	Placebo comparator	Placebo Comparator Receives: Drug: Placebo Comparator

What is being measured

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

Mean Ocular Surface Disease Index (OSDI) Total Score
The Ocular Surface Disease Index (OSDI) is a 12 item questionnaire. Each question about discomfort/limitations is scored from 0 to 4, with 0 being 'None of the Time' and 4 being 'All of the Time'. The minimum total score is 0 and the maximum total score is 48, with higher scores indicating worse outcomes.
Measured: 42 days

Timeline

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

Sep 2010Dec 2011

First posted30 Sep 2010 (estimated)
Study startSep 2010
Primary completionAug 2011
Study completionDec 2011

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 Dry Eye SyndromeStudies 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
Who is masked: Participant, Investigator
Enrolment: 840 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01212471
Sponsor's protocol ID: S00007
Status last verified: Sep 2020
First submitted: 28 Sep 2010
Last updated: 4 Sep 2020
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 Dry Eye Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease
ClinicalTrials.gov ID: NCT01212471
Acronym / sponsor ID: S00007
Conditions: Dry Eye Syndrome
Keywords: Sign and symptoms of dry eye disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 840 participants (actual)
Lead sponsor: Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
Study start: Sep 2010
Primary completion: Aug 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 30 Sep 2010 (estimated)
Results: Posted 4 Sep 2020

Clinical summary

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

A dose ranging study to evaluate safety and efficacy of bromfenac ophthalmic solution in dry eye disease.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Bromfenac Ophthalmic Solution A	Experimental	Drug: Bromfenac Ophthalmic Solution ABromfenac ophthalmic solution A
Bromfenac Ophthalmic Solution B	Experimental	Drug: Bromfenac Ophthalmic Solution BBromfenac ophthalmic solution B
Placebo Comparator	Placebo comparator	Drug: Placebo ComparatorPlacebo Comparator

Who may qualify

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

Key inclusion criteria (1 listed)

Be of either gender and any race 18 years or older

Key exclusion criteria (1 listed)

Have a local or systemic disease that could interfere with the assessment of safety or efficacy or that is likely to result in early discontinuation from the study

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
Bromfenac Ophthalmic Solution Asterile ophthalmic solution	Drug	Bromfenac Ophthalmic Solution A
Bromfenac Ophthalmic Solution Bsterile ophthalmic solution	Drug	Bromfenac Ophthalmic Solution B
Placebo Comparatorsterile ophthalmic solution	Drug	Placebo Comparator

Primary outcome

Mean Ocular Surface Disease Index (OSDI) Total Score
Time frame: 42 days
The Ocular Surface Disease Index (OSDI) is a 12 item questionnaire. Each question about discomfort/limitations is scored from 0 to 4, with 0 being 'None of the Time' and 4 being 'All of the Time'. The minimum total score is 0 and the maximum total score is 48, with higher scores indicating worse outcomes.

Results and safety

Results posted to the registry on 4 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bromfenac Ophthalmic Solution 0.06%	141	139
Bromfenac Ophthalmic Solution 0.03%	140	137
Placebo Comparator	139	132

Primary outcome: Mean Ocular Surface Disease Index (OSDI) Total Score

Time frame: 42 days. Mean (Standard Deviation). Unit: score on a scale

Measure	Bromfenac Ophthalmic Solution 0.06% n = 141	Bromfenac Ophthalmic Solution 0.03% n = 140	Placebo Comparator n = 139
Value	35.0 (22.23)	40.3 (25.22)	36.9 (23.24)

Adverse events

Time frame: 10 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bromfenac Ophthalmic Solution 0.06%	2 of 141 (1.4%)	9 of 141 (6.4%)	0 of 141
Bromfenac Ophthalmic Solution 0.03%	3 of 140 (2.1%)	8 of 140 (5.7%)	0 of 140
Placebo Comparator	1 of 139 (0.7%)	7 of 139 (5%)	0 of 139

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Dry Eye Syndrome

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TearCare in Young Adults
Meibomian Gland Dysfunction (Disorder)
Recruiting
Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease
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Not yet recruitingPhase 1
A Clinical Study to Evaluate the Safety and Effectiveness of MSCohi-O Lens in the Treatment of Immune-related Ocular Surface Diseases.
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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.

Tim McNamara, PharmD study director

ISTA Pharmaceuticals, Inc.

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 Bromfenac Ophthalmic Solution A and Bromfenac Ophthalmic Solution B in people with Dry Eye Syndrome, run by Bausch & Lomb Incorporated 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 1 inclusion and 1 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 4 Sep 2020. 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?

Yes. Results are posted in the registry (first posted 4 Sep 2020). 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?

Mean Ocular Surface Disease Index (OSDI) Total Score (time frame: 42 days). 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 NCT01212471.

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 4 Sep 2020.