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The purpose of this study is to evaluate the efficacy of loteprednol etabonate ophthalmic base, compared to loteprednol etabonate ophthalmic suspension, and vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in a modified Conjunctival Allergen Challenge model and in an environmental model during pollen season. Comparisons will be made following 2 weeks of dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Loteprednol etabonate base (QD) | Active Comparator | Loteprednol etabonate ophthalmic base dosed once/day. |
|
| Loteprednol etabonate base (BID) | Active Comparator | Loteprednol etabonate ophthalmic base dosed two times/day |
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| Loteprednol etabonate base (QID) | Active Comparator | Loteprednol etabonate ophthalmic base dosed four times/day. |
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| Loteprednol etabonate suspension (QID) | Active Comparator | Loteprednol etabonate ophthalmic suspension dosed four times/day |
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| Vehicle of loteprednol etabonate | Placebo Comparator | Vehicle of loteprednol etabonate, dosed either QD, BID, or QID |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loteprednol etabonate base (QD) | Drug | Loteprednol Etabonate ophthalmic base once daily dosing for 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Itching | Evaluated by subject at 3, 5, and 7 min post challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch. | Visit 4 (8 hr re-challenge) |
| Conjunctival Redness | Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness. | Visit 4 (8 hr re-challenge) |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Itching | Evaluated by the subject at 3, 5 and 7 min post-challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch. | Visit 3 (initial challenge) |
| Conjunctival Redness | Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tuyen Ong, MD | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb | Rochester | New York | 14603 | United States |
238 participants were screened, a total of 101 participants with seasonal and perennial allergy were randomized into the study. These 101 participants comprised the safety population, 90 of which completed the study. The ITT population was comprised of 97 subjects (4 excluded due to no post CAC-assessment).
This 2 week ocular allergy study was conducted at 2 ophthalmology clinics in the United States. The first participant was enrolled on 4/22/2010 and the last participant visit was 5/30/2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Loteprednol Etabonate Base (QD) | Loteprednol etabonate ophthalmic base dosed once/day. |
| FG001 | Loteprednol Etabonate Base (BID) | Loteprednol etabonate ophthalmic base dosed two times/day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Loteprednol etabonate base (BID) | Drug | Loteprednol etabonate ophthalmic base BID dosing for 2 weeks |
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| Loteprednol etabonate base (QID) | Drug | Loteprednol Etabonate ophthalmic base four times/day dosing for 2 week |
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| Loteprednol etabonate suspension | Drug | Loteprednol etabonate ophthalmic suspension dosed four times daily for 2 weeks. |
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| Vehicle of loteprednol etabonate | Drug | Vehicle of loteprednol etabonate ophthalmic dosed once, twice or four times daily for 2 weeks. |
|
| Visit 3 (initial challenge) |
| Ocular Itching | Evaluated by the subject at 3, 5 and 7 min post-challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch. | Visit 4 (initial challenge) |
| Conjunctival Redness | Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness. | Visit 4 (initial challenge) |
| FG002 | Loteprednol Etabonate Base (QID) | Loteprednol etabonate ophthalmic base dosed four times/day. |
| FG003 | Loteprednol Etabonate Suspension (QID) | Loteprednol etabonate ophthalmic suspension dosed four times/day |
| FG004 | Vehicle of Loteprednol Etabonate | Vehicle of loteprednol etabonate, dosed either QD, BID, or QID |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Loteprednol Etabonate Base (QD) | Loteprednol etabonate ophthalmic base dosed once/day. |
| BG001 | Loteprednol Etabonate Base (BID) | Loteprednol etabonate ophthalmic base dosed two times/day |
| BG002 | Loteprednol Etabonate Base (QID) | Loteprednol etabonate ophthalmic base dosed four times/day. |
| BG003 | Loteprednol Etabonate Suspension (QID) | Loteprednol etabonate ophthalmic suspension dosed four times/day |
| BG004 | Vehicle of Loteprednol Etabonate | Vehicle of loteprednol etabonate, dosed either QD, BID, or QID |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| 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 | Ocular Itching | Evaluated by subject at 3, 5, and 7 min post challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch. | Visit 4, Re-challenge Ocular Itching Scores - Primary Analysis ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment. | Posted | Mean | Standard Deviation | Units on a Scale | Visit 4 (8 hr re-challenge) |
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| Primary | Conjunctival Redness | Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness. | Visit 4, Re-challenge Conjunctival Hyperemia Scores, ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment. | Posted | Mean | Standard Deviation | Units on a scale | Visit 4 (8 hr re-challenge) |
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| Secondary | Ocular Itching | Evaluated by the subject at 3, 5 and 7 min post-challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch. | Visit 3 Ocular Itching Scores - ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment. | Posted | Mean | Standard Deviation | units on a scale | Visit 3 (initial challenge) |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Conjunctival Redness | Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness. | Visit 3 Conjunctival Hyperemia Scores - ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment. | Posted | Mean | Standard Deviation | units on a scale | Visit 3 (initial challenge) |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Ocular Itching | Evaluated by the subject at 3, 5 and 7 min post-challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch. | Visit 4 Ocular Itching Scores - ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment. | Posted | Mean | Standard Deviation | units on a scale | Visit 4 (initial challenge) |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Conjunctival Redness | Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness. | Visit 4 Conjunctival Hyperemia Scores - ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment. | Posted | Mean | Standard Deviation | units on a scale | Visit 4 (initial challenge) |
|
14 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 | Loteprednol Etabonate Base (QD) | Loteprednol etabonate ophthalmic base dosed once/day. | 0 | 21 | 0 | 21 | ||
| EG001 | Loteprednol Etabonate Base (BID) | Loteprednol etabonate ophthalmic base dosed two times/day | 0 | 20 | 4 | 20 | ||
| EG002 | Loteprednol Etabonate Base (QID) | Loteprednol etabonate ophthalmic base dosed four times/day. | 0 | 20 | 5 | 20 | ||
| EG003 | Loteprednol Etabonate Suspension (QID) | Loteprednol etabonate ophthalmic suspension dosed four times/day | 0 | 20 | 1 | 20 | ||
| EG004 | Vehicle of Loteprednol Etabonate | Vehicle of loteprednol etabonate, dosed either QD, BID, or QID | 0 | 20 | 6 | 20 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye irritation | Eye disorders | MedDRA (12.1) | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA (12.1) | Systematic Assessment |
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| Eye pruritis | Eye disorders | MedDRA (12.1) | Systematic Assessment |
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| Blurred vision | Eye disorders | MedDRA (12.1) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
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| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
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| Oropharyngial pain | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
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| Post nasal drip | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | MedDRA (12.1) | Systematic Assessment |
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| Blood oestrogen decreased | Investigations | MedDRA (12.1) | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
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Prior to any presentation of results, draft versions of manuscripts will be made available to co-authors and to the Sponsor for review and comment. At least 30 days in the case of abstracts or 60 days in the case of full papers should be allowed for comments prior to submission for consideration of acceptance of presentation or publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tuyen Ong, MD MRCOphth | Bausch & Lomb Incorporated | (973) 360-6389 | tuyen.ong@bausch.com |
| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C494814 | BID protein, human |
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| 20 - 64 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| 5 Min |
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| 7 Min |
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| OG004 |
| Vehicle of Loteprednol Etabonate |
Vehicle of loteprednol etabonate, dosed either QD, BID, or QID |
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| Vehicle of Loteprednol Etabonate |
Vehicle of loteprednol etabonate, dosed either QD, BID, or QID |
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| Vehicle of Loteprednol Etabonate |
Vehicle of loteprednol etabonate, dosed either QD, BID, or QID |
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| Vehicle of Loteprednol Etabonate |
Vehicle of loteprednol etabonate, dosed either QD, BID, or QID |
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| Vehicle of Loteprednol Etabonate |
Vehicle of loteprednol etabonate, dosed either QD, BID, or QID |
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