Ocular InflammationPhase 3NCT00699153

Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery

A Phase 3 study testing Loteprednol Etabonate in people with Ocular Inflammation, 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

Evaluation of the clinical safety and efficacy of loteprednol etabonate in an ophthalmic base, when compared to vehicle for the treatment of inflammation following cataract surgery. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ocular Inflammation
What is being tested?: Loteprednol Etabonate
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 400 participants
Where: 1 siteUnited States
Study dates: Jun 2008to Jun 2009
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

Subjects at least 18 years of age
Subjects who have the ability to understand and sign an informed consent form and provide Health Insurance Portability and Accountability Act (HIPAA) authorization.
Subjects who are candidate for routine, uncomplicated cataract surgery.
Subjects who are not of childbearing potential or subjects who have a negative urine pregnancy test result at screening.
Subjects must be willing and able to comply with all treatment and follow- up procedures.

Who cannot join

Subjects who have known hypersensitivity or contraindication to the study drug or its components.
Subjects who have a history or presence of chronic generalized systemic disease that the investigator feels might increase the risk to the subject or compound the result of the study.
Subjects who have a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment or follow-up.
Subjects with elevated intraocular pressure (>/= 21 mm Hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye.
Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye.
Subjects who have had ocular surgery in the study eye within 3 months or in the fellow eye within 2 weeks prior to the screening visit.

Show all 9Show fewer

Women who are pregnant or breast feeding.
Subjects who have participated in an investigational drug or device study within the last 30 days.
Subjects previously randomized in this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Cornerstone Eye Wear
High Point, North Carolina, 27262

Other trials in United States

About this study

Official title: Safety and Efficacy of Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery

Evaluation of the clinical safety and efficacy of loteprednol etabonate in an ophthalmic base, when compared to vehicle for the treatment of inflammation following cataract surgery.

Conditions: Ocular Inflammation
Being tested: Loteprednol Etabonate, Vehicle of Ophthalmic Loteprednol Etabonate

What participants receive

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

Loteprednol EtabonateDrug
Loteprednol Etabonate in an ophthalmic base will be administered to study eye 4 times a day(QID) for 14 days.
Vehicle of Ophthalmic Loteprednol EtabonateDrug
Vehicle of ophthalmic loteprednol etabonate administered postoperatively to study eye 4 times a day(QID) for 14 days.

Study groups in NCT00699153
Study group	Role	What they receive
Loteprednol Etabonate	Experimental	Loteprednol Etabonate 0.5% Receives: Drug: Loteprednol Etabonate
Vehicle	Placebo comparator	Vehicle of Ophthalmic Loteprednol Etabonate Receives: Drug: Vehicle of Ophthalmic Loteprednol Etabonate

What is being measured

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

Participants With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0
A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.
Measured: Postoperative day 8 (Visit 5)
Participants With Grade 0 (no) Pain
Pain: A positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. Grade 0 = None; 1=Minimal; 2=Mild; 3=Moderate; 4=Moderately Severe; 5=Severe
Measured: Postoperative day 8 (Visit 5)

Secondary outcomes (2)

Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit.
A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.
Measured: At each visit: Visit 4-7, postoperative days 3-18
Mean Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare
A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.
Measured: Postoperative Day 3-18 (Each follow-up Visit 4-7)

Timeline

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

Jun 2008Jun 2009

First posted17 Jun 2008 (estimated)
Study startJun 2008
Primary completionMay 2009
Study completionJun 2009

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 Ocular InflammationStudies 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: 400 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00699153
Sponsor's protocol ID: 526
Status last verified: Mar 2015
First submitted: 13 Jun 2008
Last updated: 24 Mar 2015
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 Ocular Inflammation trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery
ClinicalTrials.gov ID: NCT00699153
Acronym / sponsor ID: 526
Conditions: Ocular Inflammation
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 400 participants (actual)
Lead sponsor: Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
Study start: Jun 2008
Primary completion: May 2009 (actual)
Study completion: Jun 2009 (actual)
First posted: 17 Jun 2008 (estimated)
Results: Posted 23 Sep 2010

Clinical summary

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

Evaluation of the clinical safety and efficacy of loteprednol etabonate in an ophthalmic base, when compared to vehicle for the treatment of inflammation following cataract surgery.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Loteprednol Etabonate	Experimental	Drug: Loteprednol EtabonateLoteprednol Etabonate 0.5%
Vehicle	Placebo comparator	Drug: Vehicle of Ophthalmic Loteprednol EtabonateVehicle of Ophthalmic Loteprednol Etabonate

Who may qualify

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

Key inclusion criteria (5 listed)

Subjects at least 18 years of age
Subjects who have the ability to understand and sign an informed consent form and provide Health Insurance Portability and Accountability Act (HIPAA) authorization.
Subjects who are candidate for routine, uncomplicated cataract surgery.
Subjects who are not of childbearing potential or subjects who have a negative urine pregnancy test result at screening.
Subjects must be willing and able to comply with all treatment and follow- up procedures.

Key exclusion criteria (9 listed)

Subjects who have known hypersensitivity or contraindication to the study drug or its components.
Subjects who have a history or presence of chronic generalized systemic disease that the investigator feels might increase the risk to the subject or compound the result of the study.
Subjects who have a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment or follow-up.
Subjects with elevated intraocular pressure (>/= 21 mm Hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye.
Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye.

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
Loteprednol EtabonateLoteprednol Etabonate in an ophthalmic base will be administered to study eye 4 times a day(QID) for 14 days.	Drug	Loteprednol Etabonate
Vehicle of Ophthalmic Loteprednol EtabonateVehicle of ophthalmic loteprednol etabonate administered postoperatively to study eye 4 times a day(QID) for 14 days.	Drug	Vehicle

Primary outcome

Participants With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0
Time frame: Postoperative day 8 (Visit 5)
A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.
Participants With Grade 0 (no) Pain
Time frame: Postoperative day 8 (Visit 5)
Pain: A positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. Grade 0 = None; 1=Minimal; 2=Mild; 3=Moderate; 4=Moderately Severe; 5=Severe

2 secondary outcomes

Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit.
Time frame: At each visit: Visit 4-7, postoperative days 3-18
Mean Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare
Time frame: Postoperative Day 3-18 (Each follow-up Visit 4-7)

Results and safety

Results posted to the registry on 23 Sep 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Loteprednol Etabonate	203	200
Vehicle	202	200

Primary outcome: Participants With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0

Time frame: Postoperative day 8 (Visit 5). Number. Unit: participants

Measure	Loteprednol Etabonate n = 203	Vehicle n = 202
Value	64	23

Population analysed: Intent to treat population, subjects who had missing data or took rescue medication prior to visit 5 were imputed as no.

Primary outcome: Participants With Grade 0 (no) Pain

Time frame: Postoperative day 8 (Visit 5). Number. Unit: participants

Measure	Loteprednol Etabonate n = 203	Vehicle n = 202
Value	149	83

Population analysed: Intent to treat population

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Following drug administration visit 3 (postoperative day 1) through visit 7 (postoperative day 18).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Loteprednol Etabonate	2 of 204 (1%)	81 of 204 (39.7%)	Not reported
Vehicle	4 of 201 (2%)	151 of 201 (75.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
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.

Laura Trusso study director

Bausch & Lomb Incorporated

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 Loteprednol Etabonate in people with Ocular Inflammation, 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 5 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 24 Mar 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 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 23 Sep 2010). 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?

Participants With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0 (time frame: Postoperative day 8 (Visit 5)). 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 NCT00699153.

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 24 Mar 2015.