Seasonal Allergic ConjunctivitisPhase 3NCT01435460
Alrex® Versus Patanol in the Treatment of Seasonal Allergic Conjunctivitis(SAC)
A Phase 3 study testing Loteprednol etabonate 0.2% and Olopatadine 0.1% in people with Seasonal Allergic Conjunctivitis, run by Bausch & Lomb Incorporated at 1 site in Singapore.
Trial summary
This study is to evaluate the safety and efficacy of Alrex (LE ophthalmic suspension, 0.2%) versus Patanol (olopatadine hydrochloride ophthalmic solution, 0.1%) in the temporary relief of the signs and symptoms of Seasonal Allergic Conjunctivitis (SAC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seasonal Allergic Conjunctivitis
- What is being tested?
- Loteprednol etabonate 0.2% and Olopatadine 0.1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSingapore
- Study dates
- Aug 2010to May 2011
- 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 diagnosed with acute SAC and experience at least grade 4 ocular itching and at least grade 2 bulbar conjunctival injection (redness) in each eye due to seasonal allergy at Visit 1.
Who cannot join
- Subjects who have a known hypersensitivity to the study medications or their components or contraindications to ocular corticosteroids.
- Subjects who use any of the disallowed medications throughout the duration of the study and during the period indicated prior to Visit 1.
- Subjects who have intraocular pressure (IOP) greater than 21 mm Hg in either eye or any type of glaucoma.
- Subjects who have a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study or affect the subject's safety or trial parameters.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Safety and Efficacy Evaluation of Alrex® (Loteprednol Etabonate Ophthalmic Suspension, 0.2%) Versus Patanol (Olopatadine Hydrochloride Ophthalmic Solution, 0.1%) in the Treatment of Seasonal Allergic Conjunctivitis (SAC)
This study is to evaluate the safety and efficacy of Alrex (LE ophthalmic suspension, 0.2%) versus Patanol (olopatadine hydrochloride ophthalmic solution, 0.1%) in the temporary relief of the signs and symptoms of Seasonal Allergic Conjunctivitis (SAC).
- Conditions
- Seasonal Allergic Conjunctivitis
- Being tested
- Loteprednol etabonate 0.2%, Olopatadine 0.1%
- Keywords
- ocular allergy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loteprednol etabonate 0.2%Drug
Also called Alrex
1 drop of Alrex 4 times daily (QID) in both eyes at approximately 4 hour intervals for 2 weeks.
Olopatadine 0.1%Drug
Also called Patanol
1 drop of Patanol 2 times daily (BID)at intervals of 6-8 hours or more for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Alrex | Experimental | Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2% Receives: Drug: Loteprednol etabonate 0.2% |
| Patanol | Active comparator | Ophthalmic solution containing olopatadine, 0.1% Receives: Drug: Olopatadine 0.1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bulbar Conjunctival Injection
Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe
Measured: Change from baseline to day 15 (visit 3)
Ocular Itching
Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe
Measured: Change from baseline to day 15 (visit 3)
Secondary outcomes (2)
Bulbar Conjunctival Injection
Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe
Measured: Change from baseline to day 8 (visit 2)
Ocular Itching
Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe
Measured: Change from baseline to day 8 (visit 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2011 (estimated)
- Study startAug 2010
- Primary completionApr 2011
- Study completionMay 2011
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 Seasonal Allergic ConjunctivitisStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Esther Chu, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01435460
- Sponsor's protocol ID
- 634
- Status last verified
- Feb 2012
- First submitted
- 14 Sep 2011
- Last updated
- 13 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Gong L, Sun X, Qu J, Wang L, Zhang M, Zhang H, Wang L, Gu Y, Elion-Mboussa A, Roy L, Zhu B. Loteprednol etabonate suspension 0.2% administered QID compared with olopatadine solution 0.1% administered BID in the treatment of seasonal allergic conjunctivitis: a multicenter, randomized, investigator-masked, parallel group study in Chinese patients. Clin Ther. 2012 Jun;34(6):1259-1272.e1. doi: 10.1016/j.clinthera.2012.04.024. Epub 2012 May 23.
PubMed 22627057
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Safety and Efficacy Evaluation of Alrex® (Loteprednol Etabonate Ophthalmic Suspension, 0.2%) Versus Patanol (Olopatadine Hydrochloride Ophthalmic Solution, 0.1%) in the Treatment of Seasonal Allergic Conjunctivitis (SAC)
- ClinicalTrials.gov ID
- NCT01435460
- Acronym / sponsor ID
- 634
- Conditions
- Seasonal Allergic Conjunctivitis
- Keywords
- ocular allergy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 16 Sep 2011 (estimated)
- Results
- Posted 13 Mar 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 to evaluate the safety and efficacy of Alrex (LE ophthalmic suspension, 0.2%) versus Patanol (olopatadine hydrochloride ophthalmic solution, 0.1%) in the temporary relief of the signs and symptoms of Seasonal Allergic Conjunctivitis (SAC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alrex | Experimental | Drug: Loteprednol etabonate 0.2%Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2% |
| Patanol | Active comparator | Drug: Olopatadine 0.1%Ophthalmic solution containing olopatadine, 0.1% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects who are diagnosed with acute SAC and experience at least grade 4 ocular itching and at least grade 2 bulbar conjunctival injection (redness) in each eye due to seasonal allergy at Visit 1.
Key exclusion criteria (4 listed)
- Subjects who have a known hypersensitivity to the study medications or their components or contraindications to ocular corticosteroids.
- Subjects who use any of the disallowed medications throughout the duration of the study and during the period indicated prior to Visit 1.
- Subjects who have intraocular pressure (IOP) greater than 21 mm Hg in either eye or any type of glaucoma.
- Subjects who have a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study or affect the subject's safety or trial parameters.
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 0.2%Also: Alrex1 drop of Alrex 4 times daily (QID) in both eyes at approximately 4 hour intervals for 2 weeks. | Drug | Alrex |
| Olopatadine 0.1%Also: Patanol1 drop of Patanol 2 times daily (BID)at intervals of 6-8 hours or more for 2 weeks. | Drug | Patanol |
Primary outcome
Bulbar Conjunctival Injection
Time frame: Change from baseline to day 15 (visit 3)
Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe
Ocular Itching
Time frame: Change from baseline to day 15 (visit 3)
Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe
2 secondary outcomes
Bulbar Conjunctival Injection
Time frame: Change from baseline to day 8 (visit 2)
Ocular Itching
Time frame: Change from baseline to day 8 (visit 2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22627057Gong L, Sun X, Qu J, Wang L, Zhang M, Zhang H, Wang L, Gu Y, Elion-Mboussa A, Roy L, Zhu B. Loteprednol etabonate suspension 0.2% administered QID compared with olopatadine solution 0.1% administered BID in the treatment of seasonal allergic conjunctivitis: a multicenter, randomized, investigator-masked, parallel group study in Chinese patients. Clin Ther. 2012 Jun;34(6):1259-1272.e1. doi: 10.1016/j.clinthera.2012.04.024. Epub 2012 May 23.
Related trials for Seasonal Allergic Conjunctivitis
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
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.
Esther Chu 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 0.2% and Olopatadine 0.1% in people with Seasonal Allergic Conjunctivitis, run by Bausch & Lomb Incorporated at 1 site in Singapore.
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 13 Mar 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 Singapore. 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 13 Mar 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?
Bulbar Conjunctival Injection (time frame: Change from baseline to day 15 (visit 3)). 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 NCT01435460, 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 13 Mar 2012.