InflammationPhase 3NCT01010633

Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery

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

Search all trials

Trial summary

This study is being conducted to compare the safety and efficacy of loteprednol etabonate compared to vehicle for the treatment of postoperative inflammation and pain following cataract surgery. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Inflammation, Pain
What is being tested?: Loteprednol Etabonate
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 406 participants
Where: 1 siteUnited States
Study dates: Nov 2009to Aug 2010
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 at least 18 years of age.
Subjects who are candidates 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 have known hypersensitivity or contraindication to the study drug or components.
Subjects with 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 (>/= 21mm 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Bausch & Lomb, Inc.
Rochester, New York, 14609

Other trials in United States

About this study

This study is being conducted to compare the safety and efficacy of loteprednol etabonate compared to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.

Conditions: Inflammation, Pain
Being tested: Vehicle of Loteprednol Etabonate, Loteprednol Etabonate
Medical subject headings: Inflammation, Pain

What participants receive

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

Vehicle of Loteprednol EtabonateDrug
1 to 2 drops of vehicle administered into the study eye, 4 times a day for approximately 14 days.
Loteprednol EtabonateDrug
1 to 2 drops of study drug administered into the study eye, 4 times a day for approximately 14 days.

Study groups in NCT01010633
Study group	Role	What they receive
Loteprednol Etabonate	Experimental	Loteprednol etabonate Receives: Drug: Loteprednol Etabonate
Vehicle	Placebo comparator	Vehicle of loteprednol etabonate Receives: Drug: Vehicle of Loteprednol Etabonate

What is being measured

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

Resolution of Anterior Chamber Cells (ACC).
Number of Study eyes with complete resolution(Grade 0) of anterior chamber cells (ACC) for loteprednol and vehicle. Accumulation of white cells in aqueous graded on a scale of 0-4 where grade 0=no cells. Investigators assessed ACC using a slit lamp.
Measured: Visit 5 (Postoperative day 8)
Grade 0 Pain
Number of eyes with grade 0 ocular pain. Ocular pain, defined as a positive sensation of the eye, based on a 0-5 scale where grade 0 equaled no pain and grade 5 equaled severe pain. Ocular pain graded by participants.
Measured: Visit 5 (Postoperative Day 8)

Secondary outcomes (1)

Resolution of Anterior Chamber Cells.
Study eyes with complete resolution of anterior chamber cells (ACC)
Measured: At visits 4-7- postoperative day 3, 8,15 & 18

Timeline

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

Nov 2009Aug 2010

First posted10 Nov 2009 (estimated)
Study startNov 2009
Primary completionJun 2010
Study completionAug 2010

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for 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: 406 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01010633
Sponsor's protocol ID: 576
Status last verified: Dec 2011
First submitted: 6 Nov 2009
Last updated: 9 Jan 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Rajpal RK, Fong R, Comstock TL. Loteprednol etabonate ophthalmic gel 0.5% following cataract surgery: integrated analysis of two clinical studies. Adv Ther. 2013 Oct;30(10):907-23. doi: 10.1007/s12325-013-0059-7. Epub 2013 Oct 18.
PubMed 24136301

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

Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis

All Inflammation trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery
ClinicalTrials.gov ID: NCT01010633
Acronym / sponsor ID: 576
Conditions: Inflammation, Pain
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 406 participants (actual)
Lead sponsor: Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: Jun 2010 (actual)
Study completion: Aug 2010 (actual)
First posted: 10 Nov 2009 (estimated)
Results: Posted 9 Jan 2012

Clinical summary

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

This study is being conducted to compare the safety and efficacy of loteprednol etabonate compared to vehicle for the treatment of postoperative inflammation and pain 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
Vehicle	Placebo comparator	Drug: Vehicle of Loteprednol EtabonateVehicle of loteprednol etabonate

Who may qualify

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

Key inclusion criteria (3 listed)

Subjects who are at least 18 years of age.
Subjects who are candidates 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 have known hypersensitivity or contraindication to the study drug or components.
Subjects with 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 (>/= 21mm 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
Vehicle of Loteprednol Etabonate1 to 2 drops of vehicle administered into the study eye, 4 times a day for approximately 14 days.	Drug	Vehicle
Loteprednol Etabonate1 to 2 drops of study drug administered into the study eye, 4 times a day for approximately 14 days.	Drug	Loteprednol Etabonate

Primary outcome

Resolution of Anterior Chamber Cells (ACC).
Time frame: Visit 5 (Postoperative day 8)
Number of Study eyes with complete resolution(Grade 0) of anterior chamber cells (ACC) for loteprednol and vehicle. Accumulation of white cells in aqueous graded on a scale of 0-4 where grade 0=no cells. Investigators assessed ACC using a slit lamp.
Grade 0 Pain
Time frame: Visit 5 (Postoperative Day 8)
Number of eyes with grade 0 ocular pain. Ocular pain, defined as a positive sensation of the eye, based on a 0-5 scale where grade 0 equaled no pain and grade 5 equaled severe pain. Ocular pain graded by participants.

1 secondary outcome

Resolution of Anterior Chamber Cells.
Time frame: At visits 4-7- postoperative day 3, 8,15 & 18

Results and safety

Results posted to the registry on 9 Jan 2012, 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	203	199
Vehicle	203	198

Primary outcome: Resolution of Anterior Chamber Cells (ACC).

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

Measure	Loteprednol n = 203	Vehicle n = 203
Value	62	33

Loteprednol vs Vehicle: Mean Difference (Final Values): 14.3 (95% CI 5.7 to 22.9), p <0.001, Chi-squared

Population analysed: Intent to treat (ITT) population

Primary outcome: Grade 0 Pain

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

Measure	Loteprednol n = 203	Vehicle n = 203
Value	148	85

Loteprednol vs Vehicle: Mean Difference (Final Values): 31.0 (95% CI 21.4 to 40.7), p <0.001, Chi-squared

Population analysed: Intent to treat population (ITT)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Visit 3 post-operative day 1 thru visit 7 postoperative day 18. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Loteprednol	1 of 203 (0.5%)	0 of 203 (0%)	Not reported
Vehicle	2 of 203 (1%)	0 of 203 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24136301Rajpal RK, Fong R, Comstock TL. Loteprednol etabonate ophthalmic gel 0.5% following cataract surgery: integrated analysis of two clinical studies. Adv Ther. 2013 Oct;30(10):907-23. doi: 10.1007/s12325-013-0059-7. Epub 2013 Oct 18.

Related trials for Inflammation

Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis

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 Inflammation and Pain, 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 3 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 9 Jan 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?

Yes. Results are posted in the registry (first posted 9 Jan 2012). 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?

Resolution of Anterior Chamber Cells (ACC). (time frame: Visit 5 (Postoperative day 8)). 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 NCT01010633, which also lists 1 linked publication.

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 9 Jan 2012.