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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alrex | Experimental | Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2% |
|
| Patanol | Active Comparator | Ophthalmic solution containing olopatadine, 0.1% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loteprednol etabonate 0.2% | Drug | 1 drop of Alrex 4 times daily (QID) in both eyes at approximately 4 hour intervals for 2 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bulbar Conjunctival Injection | Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe | 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 | Change from baseline to day 15 (visit 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Bulbar Conjunctival Injection | Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe | Change from baseline to day 8 (visit 2) |
| Ocular Itching |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Esther Chu | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb Singapore | Singapore | Singapore | 556741 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22627057 | Derived | 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. |
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Three hundred participants were randomized into two groups, 151 to be treated with Alrex and 149 to be treated with Patanol.
Three hundred participants were enrolled in the study. First participant was enrolled 08/03/2010, last participant exited on 04/26/2011. This study was conducted at 7 sites in China.
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| ID | Title | Description |
|---|---|---|
| FG000 | Alrex | Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2% |
| FG001 | Patanol | Ophthalmic solution containing olopatadine, 0.1% |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Alrex | Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2% |
| BG001 | Patanol | Ophthalmic solution containing olopatadine, 0.1% |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bulbar Conjunctival Injection | Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe | Participants analyzed from the per protocol (PP) population | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to day 15 (visit 3) |
|
15 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Alrex | Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2% |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deviated Septum | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tuyen Ong | Bausch & Lomb, Incorporated | (973) 360-6389 | tuyen.ong@bausch.com |
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| ID | Term |
|---|---|
| D000069559 | Loteprednol Etabonate |
| D000069605 | Olopatadine Hydrochloride |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Olopatadine 0.1% | Drug | 1 drop of Patanol 2 times daily (BID)at intervals of 6-8 hours or more for 2 weeks. |
|
|
Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe
| Change from baseline to day 8 (visit 2) |
| Withdrawal by Subject |
|
| Protocol Violation |
|
| Did not meet eligibility criteria |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Ocular Itching | Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe | Participants analyzed from the per protocol (PP) population | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to day 15 (visit 3) |
|
|
|
| Secondary | Bulbar Conjunctival Injection | Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe | Participants analyzed from the per protocol (PP) population | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to day 8 (visit 2) |
|
|
|
| Secondary | Ocular Itching | Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe | Participants analyzed from the per protocol (PP) population | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to day 8 (visit 2) |
|
|
|
| 1 |
| 151 |
| 0 |
| 151 |
| EG001 | Patanol | Ophthalmic solution containing olopatadine, 0.1% | 0 | 149 | 0 | 149 |
All study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee and the Investigator(s) are completed. The results of the study may be published or presented by the Investigator(s)after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003990 | Dibenzoxepins |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |