Conjunctivitis, Seasonal AllergicPhase 4NCT01437982
A Study to Evaluate the Safety and Efficacy of Lotemax Ophthalmic Suspension 0.5%
A Phase 4 study testing Loteprednol Etabonate and Prednisolone Acetate 1% Oph Susp in people with Conjunctivitis, Seasonal Allergic and Conjunctivitis, Giant Papillary, run by Bausch & Lomb Incorporated at 1 site in South Korea.
Trial summary
The objective of this study is to identify any adverse events or adverse drug reactions through post-marketing surveillance under routine clinical practice Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Conjunctivitis, Seasonal Allergic, Conjunctivitis, Giant Papillary, Inflammation
- What is being tested?
- Loteprednol Etabonate and Prednisolone Acetate 1% Oph Susp
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Aug 2010to 19 Oct 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects who have been treated with the study drug at least once and completed safety follow-up.
- Subjects who have been treated with the study drug at least once and completed the clinical efficacy assessment.
Who cannot join
- Subjects not treated with study drug at least once.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Post Marketing Surveillance to Evaluate the Safety and Efficacy of Lotemax Ophthalmic Suspension 0.5%
The objective of this study is to identify any adverse events or adverse drug reactions through post-marketing surveillance under routine clinical practice
Read the detailed description
The objective of this study is to identify any adverse events or adverse drug reactions through post-marketing surveillance under routine clinical practice after marketing authorization of Lotemax ophthalmic suspension 0.5%
- Being tested
- Loteprednol Etabonate, Prednisolone Acetate 1% Oph Susp
- Keywords
- post-operative inflammation, conjunctivitis, safety, Seasonal allergic conjunctivitis, Giant papillary conjunctivitis
- Medical subject headings
- Conjunctivitis, Conjunctivitis, Allergic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loteprednol EtabonateDrug
Also called Lotemax
Ocular administration of study drug. at least once within any indication of the label.
Prednisolone Acetate 1% Oph SuspDrug
Also called Prednisolone Acetate
Ocular administration of study drug. at least once within any indication of the label.
| Study group | Role | What they receive |
|---|---|---|
| Loteprednol Etabonate | Experimental | Ophthalmic Gel 0.5% Receives: Drug: Loteprednol Etabonate |
| Prednisolone Acetate 1% Oph Susp | Experimental | Ophthalmic suspension 0.5% Receives: Drug: Prednisolone Acetate 1% Oph Susp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
All adverse events that occurred from the first dose of the study drug regardless of causality to the study drug. Changes in all undesirable medical findings and all adverse events occurring with the use of the study drug.
Measured: 4 years
Secondary outcomes (3)
Seasonal Allergic Conjunctivitis
Signs and symptoms of seasonal allergic conjunctivitis: The efficacy assessment will be evaluated according to the classification: improved, unchanged, worsened, impossible to assess.
Measured: 4 years
Giant Papillary Conjunctivitis
Signs and symptoms of giant papillary conjunctivitis: The results of the efficacy assessment will be evaluated according to the classification: improved, unchanged, worsened, impossible to assess.
Measured: 4 years
Post-operative inflammation
Treatment of post-operative inflammation following ocular surgery: The results of the final efficacy assessment will be evaluated according to the classification: improved, unchanged, worsened, impossible to assess.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2011 (estimated)
- Study start5 Aug 2010
- Primary completion19 Oct 2015
- Study completion19 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conjunctivitis, Seasonal AllergicStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Binu Alexander, MD, Study director, Valeant Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01437982
- Sponsor's protocol ID
- 628
- Status last verified
- Nov 2019
- First submitted
- 20 Sep 2011
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Marketing Surveillance to Evaluate the Safety and Efficacy of Lotemax Ophthalmic Suspension 0.5%
- ClinicalTrials.gov ID
- NCT01437982
- Acronym / sponsor ID
- 628
- Keywords
- post-operative inflammation, conjunctivitis, safety, Seasonal allergic conjunctivitis, Giant papillary conjunctivitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2010 (actual)
- Primary completion
- 19 Oct 2015 (actual)
- Study completion
- 19 Oct 2015 (actual)
- First posted
- 21 Sep 2011 (estimated)
- Results
- Not posted in the source record
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 identify any adverse events or adverse drug reactions through post-marketing surveillance under routine clinical practice
Detailed description
The objective of this study is to identify any adverse events or adverse drug reactions through post-marketing surveillance under routine clinical practice after marketing authorization of Lotemax ophthalmic suspension 0.5%
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Loteprednol Etabonate | Experimental | Drug: Loteprednol EtabonateOphthalmic Gel 0.5% |
| Prednisolone Acetate 1% Oph Susp | Experimental | Drug: Prednisolone Acetate 1% Oph SuspOphthalmic suspension 0.5% |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects who have been treated with the study drug at least once and completed safety follow-up.
- Subjects who have been treated with the study drug at least once and completed the clinical efficacy assessment.
Key exclusion criteria (1 listed)
- Subjects not treated with study drug at least once.
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: LotemaxOcular administration of study drug. at least once within any indication of the label. | Drug | Loteprednol Etabonate |
| Prednisolone Acetate 1% Oph SuspAlso: Prednisolone AcetateOcular administration of study drug. at least once within any indication of the label. | Drug | Prednisolone Acetate 1% Oph Susp |
Primary outcome
Safety
Time frame: 4 years
All adverse events that occurred from the first dose of the study drug regardless of causality to the study drug. Changes in all undesirable medical findings and all adverse events occurring with the use of the study drug.
3 secondary outcomes
Seasonal Allergic Conjunctivitis
Time frame: 4 years
Giant Papillary Conjunctivitis
Time frame: 4 years
Post-operative inflammation
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
Related trials for Conjunctivitis, Seasonal Allergic
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
Allergic Rhinoconjunctivitis
Active, not recruitingObservational study
Tyrosine Allergoid Paediatric and Adult Study
Allergic Rhinitis Due to Pollen, Allergic Conjunctivitis
RecruitingPhase 2
Evaluation of TL-925 for the Treatment of Seasonal Allergic Conjunctivitis
Allergic Conjunctivitis
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.
Binu Alexander, MD study director
Valeant Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Loteprednol Etabonate and Prednisolone Acetate 1% Oph Susp in people with Conjunctivitis, Seasonal Allergic and Conjunctivitis, Giant Papillary, run by Bausch & Lomb Incorporated at 1 site in South Korea.
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 1 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 19 Nov 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 South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety (time frame: 4 years). 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 19 Nov 2019.