Ocular InflammationPhase 3NCT00645671

Loteprednol Etabonate Ophthalmic Ointment vs. Vehicle in the Treatment of Inflammation Following Cataract Surgery

A Phase 3 study testing 0.5% Loteprednol Etabonate Ophthalmic Ointment 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

To evaluate the clinical safety and efficacy of Loteprednol Etabonate Ophthalmic Ointment, 0.5% vs. 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?: 0.5% Loteprednol Etabonate Ophthalmic Ointment
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 400 participants
Where: 1 siteUnited States
Study dates: Mar 2008to Mar 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 who are candidate for routine, uncomplicated cataract surgery
Subjects who, in the Investigator's opinion, have potential postoperative pinholed Snellen visual acuity (VA) of at least 20/200 in the study eye.

Who cannot join

Subjects who will require concurrent ocular therapy with NSAIDs, mast cell stabilizers, antihistamines, decongestants, or immunosuppressants (e.g., Restasis), or with ocular or systemic corticosteroids
Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components
Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye
Subjects who have had ocular surgery (including laser surgery) in the study eye within 3 months or in the fellow eye within 2 weeks prior to the Screening Visit

Trial locations and contacts

1 site in 1 country.

United States1 site

John Hunkeler, MD
Overland Park, Kansas, 66210

Other trials in United States

About this study

Official title: A Randomized Multicenter, Double-Masked, Parallel-Group Clinical Safety and Efficacy Evaluation of Loteprednol Etabonate Ophthalmic Ointment, 0.5% Versus Vehicle for the Treatment of Inflammation Following Cataract Surgery

To evaluate the clinical safety and efficacy of Loteprednol Etabonate Ophthalmic Ointment, 0.5% vs. vehicle for the treatment of inflammation following cataract surgery

Conditions: Ocular Inflammation
Being tested: 0.5% Loteprednol Etabonate Ophthalmic Ointment, Vehicle of Loteprednol Etabonate Ophthalmic Ointment

What participants receive

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

0.5% Loteprednol Etabonate Ophthalmic OintmentDrug
1/2 inch ribbon four times a day for 14 days
Vehicle of Loteprednol Etabonate Ophthalmic OintmentDrug
1/2 inch ribbon four times a day for 14 days

Study groups in NCT00645671
Study group	Role	What they receive
Loteprednol Etabonate	Experimental	Loteprednol etabonate 0.5% ophthalmic ointment Receives: Drug: 0.5% Loteprednol Etabonate Ophthalmic Ointment
Vehicle	Placebo comparator	Vehicle of loteprednol etabonate ointment Receives: Drug: Vehicle of Loteprednol Etabonate Ophthalmic Ointment

What is being measured

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

Subjects 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)
Grade 0 for 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)

Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up 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 follow-up visit through day18 (Visit 7)
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: Baseline and each follow-up visit through day18 (Visit 7)

Timeline

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

Mar 2008Mar 2009

First posted28 Mar 2008 (estimated)
Study startMar 2008
Primary completionMar 2009
Study completionMar 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: NCT00645671
Sponsor's protocol ID: 525
Status last verified: Mar 2015
First submitted: 13 Mar 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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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: A Randomized Multicenter, Double-Masked, Parallel-Group Clinical Safety and Efficacy Evaluation of Loteprednol Etabonate Ophthalmic Ointment, 0.5% Versus Vehicle for the Treatment of Inflammation Following Cataract Surgery
ClinicalTrials.gov ID: NCT00645671
Acronym / sponsor ID: 525
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: Mar 2008
Primary completion: Mar 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 28 Mar 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.

To evaluate the clinical safety and efficacy of Loteprednol Etabonate Ophthalmic Ointment, 0.5% vs. 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: 0.5% Loteprednol Etabonate Ophthalmic OintmentLoteprednol etabonate 0.5% ophthalmic ointment
Vehicle	Placebo comparator	Drug: Vehicle of Loteprednol Etabonate Ophthalmic OintmentVehicle of loteprednol etabonate ointment

Who may qualify

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

Key inclusion criteria (2 listed)

Subjects who are candidate for routine, uncomplicated cataract surgery
Subjects who, in the Investigator's opinion, have potential postoperative pinholed Snellen visual acuity (VA) of at least 20/200 in the study eye.

Key exclusion criteria (4 listed)

Subjects who will require concurrent ocular therapy with NSAIDs, mast cell stabilizers, antihistamines, decongestants, or immunosuppressants (e.g., Restasis), or with ocular or systemic corticosteroids
Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components
Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye
Subjects who have had ocular surgery (including laser surgery) in the study eye within 3 months or in the fellow eye within 2 weeks prior to the Screening Visit

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
0.5% Loteprednol Etabonate Ophthalmic Ointment1/2 inch ribbon four times a day for 14 days	Drug	Loteprednol Etabonate
Vehicle of Loteprednol Etabonate Ophthalmic Ointment1/2 inch ribbon four times a day for 14 days	Drug	Vehicle

Primary outcome

Subjects 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.
Grade 0 for 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

Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up Visit.
Time frame: At each follow-up visit through day18 (Visit 7)
Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare
Time frame: Baseline and each follow-up visit through day18 (Visit 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	201	200
Vehicle	199	193

Primary outcome: Subjects 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 = 201	Vehicle n = 199
Yes	48	27
No	153	172

Population analysed: Intent to treat population

Primary outcome: Grade 0 for Pain

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

Measure	Loteprednol Etabonate n = 201	Vehicle n = 199
Yes	156	90
No	45	109

Population analysed: Intent to treat population

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: The LE treatment group had a mean exposure of 13.2 days (+/-3.06), the vehicle treatment group mean exposure was 9.2 days (+/-5.10). Mean days of exposure was < 14 days due to the use of rescue medication, especially in the vehicle group.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Loteprednol Etabonate	3 of 201 (1.5%)	110 of 201 (54.7%)	Not reported
Vehicle	2 of 199 (1%)	161 of 199 (80.9%)	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.

Alyson J Berliner, MD/PhD 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 0.5% Loteprednol Etabonate Ophthalmic Ointment 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 2 inclusion and 4 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?

Subjects 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 NCT00645671.

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.