InflammationPhase 3NCT01996839
Loteprednol Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
A Phase 3 study testing Loteprednol Etabonate Gel (BID) and Loteprednol Etabonate Gel (TID) in people with Inflammation and Pain, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate ophthalmic gel Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammation, Pain, Cataract
- What is being tested?
- Loteprednol Etabonate Gel (BID) and Loteprednol Etabonate Gel (TID)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 514 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Jul 2014
- 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
- Visit 1 (Screening Visit)
- Be willing and able to comply with all treatment and follow-up/study procedures.
- Be a candidate for routine, uncomplicated cataract surgery
- Visit 3 (Postoperative Day 1)
- Have undergone routine, uncomplicated cataract surgery (phaco- emulsification with posterior chamber IOL implantation, not combined with any other surgery) in the study eye.
- Have ≥ Grade 2 anterior chamber (AC) cells (6-15 cells) in the study eye.
Who cannot join
- Have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.
- Have known hypersensitivity or contraindication to the study drug(s) or their components.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bausch & Lomb Incorporated
Bridgewater, New Jersey, 08807
About this study
Official title: Loteprednol Etabonate Ophthalmic Gel, 0.38% (BID and TID) Versus Vehicle Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate ophthalmic gel
Read the detailed description
The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate ophthalmic gel, 0.38% (BID and TID) for the treatment of postoperative inflammation and pain following cataract surgery.
- Conditions
- Inflammation, Pain, Cataract
- Being tested
- Loteprednol Etabonate Gel (BID), Loteprednol Etabonate Gel (TID), Vehicle (BID), Vehicle (TID)
- Medical subject headings
- Inflammation, Pain, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loteprednol Etabonate Gel (BID)Drug
Also called Lotemax
One drop of LE gel instilled into the study eye two times per day (BID) for 14 days
Loteprednol Etabonate Gel (TID)Drug
Also called Lotemax
One drop of LE gel instilled into the study eye three times per day (TID) for 14 days.
Vehicle (BID)Drug
Also called Vehicle
One drop of vehicle instilled into the study eye two times per day (BID) for 14 days
Vehicle (TID)Drug
Also called Vehicle
One drop of vehicle instilled into the study eye three times per day (TID) for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Loteprednol Etabonate Gel (BID) | Experimental | Loteprednol Etabonate Gel 0.38% administered two times daily (BID). Receives: Drug: Loteprednol Etabonate Gel (BID) |
| Vehicle (BID) | Active comparator | Vehicle of Loteprednol Etabonate Gel 0.38% administered two times daily (BID). Receives: Drug: Vehicle (BID) |
| Loteprednol Etabonate Gel (TID) | Experimental | Loteprednol Gel 0.38% administered three times daily (TID). Receives: Drug: Loteprednol Etabonate Gel (TID) |
| Vehicle (TID) | Active comparator | Vehicle of Loteprednol Etabonate Gel 0.38% administered three times daily (TID). Receives: Drug: Vehicle (TID) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells
White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye.
Measured: 8 days
Percentage of Participants With Grade 0 Pain in the Study Eye.
Ocular pain, defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching, was assessed and graded by subjects on the 6-point scale, with 0=None and 5=Severe.
Measured: 8 days
Secondary outcomes (4)
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit
White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye.
Measured: 18 days
Percentage of Participants With Grade 0 Pain in the Study Eye by Visit.
White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye.
Measured: 18 days
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye by Visit.
Flare was evaluated by the Investigator by assessing the scattering of a slit lamp light beam directed into the anterior chamber (Tyndall effect). Flare was graded on the 5-point scale, with 0=None (best) and 4=Very Severe (worst). Complete resolution of AC flare was defined as Grade 0.
Measured: 18 days
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and AC Flare in the Study Eye by Visit.
White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye. Flare was evaluated by the Investigator by assessing the scattering of a slit lamp light beam directed into the anterior chamber (Tyndall effect). Flare was graded on the 5-point scale, with 0=None (best) and 4=Very Severe (worst).
Measured: 18 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionMay 2014
- Study completionJul 2014
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 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
- 514 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jon I Williams, PhD, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01996839
- Sponsor's protocol ID
- 842
- Status last verified
- Sep 2020
- First submitted
- 22 Nov 2013
- Last updated
- 25 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Loteprednol Etabonate Ophthalmic Gel, 0.38% (BID and TID) Versus Vehicle Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
- ClinicalTrials.gov ID
- NCT01996839
- Acronym / sponsor ID
- 842
- Conditions
- Inflammation, Pain, Cataract
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 514 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 27 Nov 2013 (estimated)
- Results
- Posted 3 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate ophthalmic gel
Detailed description
The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate ophthalmic gel, 0.38% (BID and TID) 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
- 4
| Arm | Type | Receives |
|---|---|---|
| Loteprednol Etabonate Gel (BID) | Experimental | Drug: Loteprednol Etabonate Gel (BID)Loteprednol Etabonate Gel 0.38% administered two times daily (BID). |
| Vehicle (BID) | Active comparator | Drug: Vehicle (BID)Vehicle of Loteprednol Etabonate Gel 0.38% administered two times daily (BID). |
| Loteprednol Etabonate Gel (TID) | Experimental | Drug: Loteprednol Etabonate Gel (TID)Loteprednol Gel 0.38% administered three times daily (TID). |
| Vehicle (TID) | Active comparator | Drug: Vehicle (TID)Vehicle of Loteprednol Etabonate Gel 0.38% administered three times daily (TID). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Visit 1 (Screening Visit)
- Be willing and able to comply with all treatment and follow-up/study procedures.
- Be a candidate for routine, uncomplicated cataract surgery
- Visit 3 (Postoperative Day 1)
- Have undergone routine, uncomplicated cataract surgery (phaco- emulsification with posterior chamber IOL implantation, not combined with any other surgery) in the study eye.
Key exclusion criteria (2 listed)
- Have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.
- Have known hypersensitivity or contraindication to the study drug(s) or their components.
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 Etabonate Gel (BID)Also: LotemaxOne drop of LE gel instilled into the study eye two times per day (BID) for 14 days | Drug | Loteprednol Etabonate Gel (BID) |
| Loteprednol Etabonate Gel (TID)Also: LotemaxOne drop of LE gel instilled into the study eye three times per day (TID) for 14 days. | Drug | Loteprednol Etabonate Gel (TID) |
| Vehicle (BID)Also: VehicleOne drop of vehicle instilled into the study eye two times per day (BID) for 14 days | Drug | Vehicle (BID) |
| Vehicle (TID)Also: VehicleOne drop of vehicle instilled into the study eye three times per day (TID) for 14 days | Drug | Vehicle (TID) |
Primary outcome
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells
Time frame: 8 days
White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye.
Percentage of Participants With Grade 0 Pain in the Study Eye.
Time frame: 8 days
Ocular pain, defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching, was assessed and graded by subjects on the 6-point scale, with 0=None and 5=Severe.
4 secondary outcomes
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit
Time frame: 18 days
Percentage of Participants With Grade 0 Pain in the Study Eye by Visit.
Time frame: 18 days
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye by Visit.
Time frame: 18 days
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and AC Flare in the Study Eye by Visit.
Time frame: 18 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
- 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.
Jon I Williams, 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 Loteprednol Etabonate Gel (BID) and Loteprednol Etabonate Gel (TID) 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 6 inclusion and 2 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 25 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. 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 3 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?
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells (time frame: 8 days). 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?
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 25 Sep 2020.