CataractPhase 3NCT01475643
Loteprednol vs Prednisolone for the Treatment of Intraocular Inflammation Following Cataract Surgery in Children.
A Phase 3 study testing Loteprednol etabonate and Prednisolones acetate in people with Cataract, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
The objective of this study is to compare the efficacy and safety for the treatment of postoperative inflammation following ocular surgery for childhood cataract. Read more about this study
- Who is it for?
- Ages Up to 11 years
- Conditions the study is for
- Cataract
- What is being tested?
- Loteprednol etabonate and Prednisolones acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Jul 2017
- 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 Up to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject is a candidate for routine, uncomplicated surgery for childhood cataract
Who cannot join
- 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 glaucoma, ocular hypertension, or those receiving intraocular pressure (IOP) lowering therapy in either eye or systemically.
- Subjects with a history of steroid-induced IOP elevation in either eye.
- Subjects who have known hypersensitivity or other contraindication to the study drug(s) or any components in the drug formulation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Topical Loteprednol Etabonate 0.5%, Versus Prednisolone Acetate 1%, for the Treatment of Intraocular Inflammation Following Surgery for Childhood Cataract
The objective of this study is to compare the efficacy and safety for the treatment of postoperative inflammation following ocular surgery for childhood cataract.
Read the detailed description
The objective of this study is to compare the efficacy and safety of topical Loteprednol Etabonate (LE), 0.5%, to Prednisolone Acetate 1%, for the treatment of postoperative inflammation following ocular surgery for childhood cataract.
- Conditions
- Cataract
- Being tested
- Loteprednol etabonate, Prednisolones acetate
- Keywords
- Pediatric cataract
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loteprednol etabonateDrug
Also called LE
1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days.
Prednisolones acetateDrug
Also called PA
1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Loteprednol etabonate | Experimental | Loteprednol etabonate 0.5% Receives: Drug: Loteprednol etabonate |
| Prednisolones acetate | Active comparator | Prednisolone acetate 1.0% Receives: Drug: Prednisolones acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior Chamber Inflammation
Anterior Chamber Inflammation (for subjects that could only be examined with a pen light and a 20D [g20 Diopter] magnifying lens): 0 = None Clear anterior chamber with no visible clouding (Tyndall effect and cells combined). Red reflex normal
- = Mild Mild anterior chamber clouding. Clear iris pattern on visualization. Red reflex normal
- = Moderate Moderate anterior chamber clouding
- = Severe Severe anterior chamber clouding. Iris pattern not clearly visualized. Red reflex diminished
- = Very severe Severe anterior chamber clouding with a white and/or milky appearance of the anterior chamber. Red reflex absent or severely diminished
Measured: Postoperative Day 29
Secondary outcomes (1)
Anterior Chamber Cells & Flare
Anterior Chamber Flare (for those subjects that could be examined with a slit lamp):
Assessed scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0 = None No Tyndall effect
- = Mild Tyndall effect barely discernible
- = Moderate Tyndall effect in anterior chamber is moderately intense. Iris pattern is seen clearly
- = Severe Tyndall effect in anterior chamber is severely intense. Iris pattern cannot be seen clearly
- = Very severe Tyndall effect is very severely intense. The aqueous has a white and milky appearance
Measured: Over all visits 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2011 (estimated)
- Study startJun 2013
- Primary completion2 Jun 2017
- Study completionJul 2017
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 CataractStudies 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
- Care provider, Investigator
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson Varughese, Study director, Valeant/Bausch & Lomb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01475643
- Sponsor's protocol ID
- 670
- Status last verified
- Jun 2019
- First submitted
- 17 Nov 2011
- Last updated
- 11 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Topical Loteprednol Etabonate 0.5%, Versus Prednisolone Acetate 1%, for the Treatment of Intraocular Inflammation Following Surgery for Childhood Cataract
- ClinicalTrials.gov ID
- NCT01475643
- Acronym / sponsor ID
- 670
- Conditions
- Cataract
- Keywords
- Pediatric cataract
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jun 2013 (actual)
- Primary completion
- 2 Jun 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 21 Nov 2011 (estimated)
- Results
- Posted 11 Jun 2019
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 compare the efficacy and safety for the treatment of postoperative inflammation following ocular surgery for childhood cataract.
Detailed description
The objective of this study is to compare the efficacy and safety of topical Loteprednol Etabonate (LE), 0.5%, to Prednisolone Acetate 1%, for the treatment of postoperative inflammation following ocular surgery for childhood cataract.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Loteprednol etabonate | Experimental | Drug: Loteprednol etabonateLoteprednol etabonate 0.5% |
| Prednisolones acetate | Active comparator | Drug: Prednisolones acetatePrednisolone acetate 1.0% |
Who may qualify
- Ages
- Up to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Subject is a candidate for routine, uncomplicated surgery for childhood cataract
Key exclusion criteria (4 listed)
- 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 glaucoma, ocular hypertension, or those receiving intraocular pressure (IOP) lowering therapy in either eye or systemically.
- Subjects with a history of steroid-induced IOP elevation in either eye.
- Subjects who have known hypersensitivity or other contraindication to the study drug(s) or any components in the drug formulation.
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 etabonateAlso: LE1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days. | Drug | Loteprednol etabonate |
| Prednisolones acetateAlso: PA1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days. | Drug | Prednisolones acetate |
Primary outcome
Anterior Chamber Inflammation
Time frame: Postoperative Day 29
Anterior Chamber Inflammation (for subjects that could only be examined with a pen light and a 20D [g20 Diopter] magnifying lens): 0 = None Clear anterior chamber with no visible clouding (Tyndall effect and cells combined). Red reflex normal 1. = Mild Mild anterior chamber clouding. Clear iris pattern on visualization. Red reflex normal 2. = Moderate Moderate anterior chamber clouding 3. = Severe Severe anterior chamber clouding. Iris pattern not clearly visualized. Red reflex diminished 4. = Very severe Severe anterior chamber clouding with a white and/or milky appearance of the anterior chamber. Red reflex absent or severely diminished
1 secondary outcome
Anterior Chamber Cells & Flare
Time frame: Over all visits 42 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Johnson Varughese study director
Valeant/Bausch & Lomb
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 and Prednisolones acetate in people with Cataract, 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 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 11 Jun 2019. 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 11 Jun 2019). 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?
Anterior Chamber Inflammation (time frame: Postoperative Day 29). 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 11 Jun 2019.