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The purpose of this study was to evaluate the efficacy of Maxidex and Patanol compared to placebo in patients with allergic conjunctivitis when exposed to controlled allergen levels in an Environmental Exposure Chamber (EEC).
This study consisted of 6 visits. Visit 1 was the Medical Screening Visit (skin prick test). Visit 2 and Visit 3 consisted of 2 consecutive EEC Visits (3 hours in the EEC followed by 7 hours in the Clinic, 10 hours total, each visit) followed by 7 days of wash-out. Visit 2 and Visit 3 occurred prior to dispense and the measures obtained during these visits were used as baseline. At Visit 4 patients were randomized and dispensed the assigned study medication for 7 days of at-home dosing. Visit 5 (Day 8 of treatment) and Visit 6 (Day 9 of treatment) consisted of 2 additional consecutive EEC Visits (3 hours in the EEC followed by 7 hours in the clinic, 10 hours total, each visit). During each EEC visit, patients were exposed to either ragweed or cat allergen, depending on their skin prick test results. Of the 180 participants enrolled, 170 received at least one dose of study treatment and were randomized to one of the three study treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maxidex | Experimental | Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only] |
|
| Patanol | Experimental | Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only] |
|
| Tears Naturale II | Placebo Comparator | Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only] |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone 0.1% ophthalmic suspension | Drug | Maxidex |
| |
| Olopatadine hydrochloride 0.1% ophthalmic solution |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Staff-Assessed Ocular Redness, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)], Maxidex and Placebo | Ocular redness ratings were collected for nasal and temporal areas of each eye and scored on a scale from 0 (none) to 4 (extremely severe), 0.5 unit steps permitted. The AUC computation was based on peak redness score (maximum of four areas of redness) at each time point (pre-treatment, 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3 hours in the EEC and 3.5, 4, 5, 6, 7, 8, 9, 10 hours in the Clinic). The patient was dosed AM 30 minutes prior to entering the EEC (Visit 6). This outcome measure evaluates a late-phase effect, for which Maxidex vs. Placebo is the meaningful comparison. | Baseline (Visit 3, pre-treatment); Visit 6 (Day 9 of treatment) |
| Mean Change From Baseline Patient-Assessed Ocular Itching, Area Under the Curve From Time Zero to Hour 3 [AUC (0-3)], Patanol and Placebo | Ocular itching was scored a scale from 0 (none) to 4 (incapacitating itch with irresistible urge to rub) in 0.5 unit steps. The AUC computation was based on the score at each time point (pre-treatment, 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, and 3 hours in the EEC). The patient was dosed AM 30 minutes prior to entering the EEC (Visit 5). This outcome measure evaluates an early-phase effect, for which Patanol vs. Placebo is the meaningful comparison. | Baseline (Visit 2, pre-treatment), Visit 5 (Day 8 of treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center For Trial Locations | Fort Worth | Texas | 76134 | United States |
Of the 180 patients enrolled, 170 were identified as either ragweed allergic or cat allergic, randomized to one of three study treatments, and received at least one dose of study treatment. Ten additional patients identified as ragweed allergic participated in Visits 1 to 3 only, per protocol design.
Patients were recruited from one study center in Canada.
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| ID | Title | Description |
|---|---|---|
| FG000 | Maxidex/Ragweed Allergic | Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only] |
| FG001 | Patanol/Ragweed Allergic |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
Patanol |
|
| Inactive ingredients, used as placebo | Other | Tears Naturale II |
|
Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
| FG002 | Tears Naturale II/Ragweed Allergic | Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only] |
| FG003 | Maxidex/Cat Allergic | Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only] |
| FG004 | Patanol/Cat Allergic | Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only] |
| FG005 | Tears Naturale II/Cat Allergic | Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only] |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Maxidex/Ragweed Allergic | Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only] |
| BG001 | Patanol/Ragweed Allergic | Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only] |
| BG002 | Tears Naturale II/Ragweed Allergic | Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only] |
| BG003 | Maxidex/Cat Allergic | Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only] |
| BG004 | Patanol/Cat Allergic | Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only] |
| BG005 | Tears Naturale II/Cat Allergic | Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only] |
| BG006 | 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Mean Change From Baseline in Staff-Assessed Ocular Redness, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)], Maxidex and Placebo | Ocular redness ratings were collected for nasal and temporal areas of each eye and scored on a scale from 0 (none) to 4 (extremely severe), 0.5 unit steps permitted. The AUC computation was based on peak redness score (maximum of four areas of redness) at each time point (pre-treatment, 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3 hours in the EEC and 3.5, 4, 5, 6, 7, 8, 9, 10 hours in the Clinic). The patient was dosed AM 30 minutes prior to entering the EEC (Visit 6). This outcome measure evaluates a late-phase effect, for which Maxidex vs. Placebo is the meaningful comparison. | Number of subjects with data available in the specific treatment group | Posted | Mean | Standard Deviation | hours x units on a scale | Baseline (Visit 3, pre-treatment); Visit 6 (Day 9 of treatment) |
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| Primary | Mean Change From Baseline Patient-Assessed Ocular Itching, Area Under the Curve From Time Zero to Hour 3 [AUC (0-3)], Patanol and Placebo | Ocular itching was scored a scale from 0 (none) to 4 (incapacitating itch with irresistible urge to rub) in 0.5 unit steps. The AUC computation was based on the score at each time point (pre-treatment, 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, and 3 hours in the EEC). The patient was dosed AM 30 minutes prior to entering the EEC (Visit 5). This outcome measure evaluates an early-phase effect, for which Patanol vs. Placebo is the meaningful comparison. | Number of subjects with data available in the specific treatment group | Posted | Mean | Standard Deviation | hours x units on a scale | Baseline (Visit 2, pre-treatment), Visit 5 (Day 8 of treatment) |
|
Adverse events were collected for the duration of the study (5 months, 29 days).
The safety population included all randomized patients. Adverse events were reported for any clinically relevant untoward (unfavorable and unintended) change from baseline in the patient's medical health following exposure to the study treatment, as reported spontaneously by the patient and solicited by the investigator.
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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 | Maxidex | Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only] | 0 | 57 | 13 | 57 | ||
| EG001 | Patanol | Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only] | 0 | 55 | 7 | 55 | ||
| EG002 | Tears Naturale II | Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only] | 0 | 58 | 7 | 58 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye irritation | Eye disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head, Alcon Clinical | Alcon Research | 1-888-451-3937 |
| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| D003231 | Conjunctivitis |
| ID | Term |
|---|---|
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D000069605 | Olopatadine Hydrochloride |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D003990 | Dibenzoxepins |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
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| Male |
|
| Visit 6 (Day 9 of treatment) |
|
| Change |
|
| OG003 | Tears Naturale II/Cat Allergic | Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only] |
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