Allergic Conjunctivitis
Conditions
Keywords
Conjunctivitis, ocular allergy
Brief summary
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).
Detailed description
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.
Interventions
Maxidex
OTHERInactive ingredients, used as placebo
Tears Naturale II
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* At least 1 year history of allergic conjunctivitis. * Ability to self administer ophthalmic drops. * Ability to avoid use of disallowed medications during the entire study period and specified period prior to visit 1. * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Presence of any ocular infection. * Confirmed diagnosis of dry eye. * Presence of glaucoma or ocular hypertension. * Moderate to severe asthma. * Any severe, unstable, or uncontrolled systemic disease. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline (Visit 3, pre-treatment); Visit 6 (Day 9 of treatment) | 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. |
| Mean Change From Baseline Patient-Assessed Ocular Itching, Area Under the Curve From Time Zero to Hour 3 [AUC (0-3)], Patanol and Placebo | Baseline (Visit 2, pre-treatment), Visit 5 (Day 8 of treatment) | 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. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from one study center in Canada.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Maxidex/Ragweed Allergic Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\] | 26 |
| Patanol/Ragweed Allergic Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\] | 24 |
| 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 \[Visit 4 through Visit 6 morning only\] | 26 |
| Maxidex/Cat Allergic Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\] | 31 |
| Patanol/Cat Allergic Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\] | 31 |
| 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 \[Visit 4 through Visit 6 morning only\] | 32 |
| Total | 170 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Patient Decision, not related to AE | 0 | 0 | 2 | 2 | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Maxidex/Ragweed Allergic | Patanol/Ragweed Allergic | Tears Naturale II/Ragweed Allergic | Maxidex/Cat Allergic | Patanol/Cat Allergic | Tears Naturale II/Cat Allergic |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 35.91 years STANDARD_DEVIATION 10.62 | 34.0 years STANDARD_DEVIATION 9.6 | 39.2 years STANDARD_DEVIATION 13.8 | 40.0 years STANDARD_DEVIATION 10 | 34.5 years STANDARD_DEVIATION 11.6 | 32.9 years STANDARD_DEVIATION 9.3 | 35.9 years STANDARD_DEVIATION 8.4 |
| Region of Enrollment Canada | 170 participants | 26 participants | 24 participants | 26 participants | 31 participants | 31 participants | 32 participants |
| Sex: Female, Male Female | 110 Participants | 11 Participants | 13 Participants | 17 Participants | 23 Participants | 22 Participants | 24 Participants |
| Sex: Female, Male Male | 60 Participants | 15 Participants | 11 Participants | 9 Participants | 8 Participants | 9 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 13 / 57 | 7 / 55 | 7 / 58 |
| serious Total, serious adverse events | 0 / 57 | 0 / 55 | 0 / 58 |
Outcome results
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.
Time frame: Baseline (Visit 3, pre-treatment); Visit 6 (Day 9 of treatment)
Population: Number of subjects with data available in the specific treatment group
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Maxidex/Ragweed Allergic | 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 | Baseline (Visit 3, pre-treatment) | 18.120 hours x units on a scale | Standard Deviation 6.26 |
| Maxidex/Ragweed Allergic | 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 | Change | -6.450 hours x units on a scale | Standard Deviation 7.002 |
| Maxidex/Ragweed Allergic | 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 | Visit 6 (Day 9 of treatment) | 11.671 hours x units on a scale | Standard Deviation 5.983 |
| Tears Naturale II/Ragweed Allergic | 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 | Baseline (Visit 3, pre-treatment) | 19.362 hours x units on a scale | Standard Deviation 7.666 |
| Tears Naturale II/Ragweed Allergic | 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 | Change | -3.576 hours x units on a scale | Standard Deviation 6.959 |
| Tears Naturale II/Ragweed Allergic | 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 | Visit 6 (Day 9 of treatment) | 15.786 hours x units on a scale | Standard Deviation 6.514 |
| Maxidex/Cat Allergic | 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 | Visit 6 (Day 9 of treatment) | 11.313 hours x units on a scale | Standard Deviation 3.943 |
| Maxidex/Cat Allergic | 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 | Baseline (Visit 3, pre-treatment) | 16.823 hours x units on a scale | Standard Deviation 5.53 |
| Maxidex/Cat Allergic | 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 | Change | -5.511 hours x units on a scale | Standard Deviation 5.916 |
| Tears Naturale II/Cat Allergic | 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 | Baseline (Visit 3, pre-treatment) | 17.572 hours x units on a scale | Standard Deviation 6.803 |
| Tears Naturale II/Cat Allergic | 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 | Change | -3.748 hours x units on a scale | Standard Deviation 6.351 |
| Tears Naturale II/Cat Allergic | 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 | Visit 6 (Day 9 of treatment) | 13.824 hours x units on a scale | Standard Deviation 4.792 |
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.
Time frame: Baseline (Visit 2, pre-treatment), Visit 5 (Day 8 of treatment)
Population: Number of subjects with data available in the specific treatment group
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Maxidex/Ragweed Allergic | Mean Change From Baseline Patient-Assessed Ocular Itching, Area Under the Curve From Time Zero to Hour 3 [AUC (0-3)], Patanol and Placebo | Baseline (Visit 2, pre-treatment) | 4.776 hours x units on a scale | Standard Deviation 1.759 |
| Maxidex/Ragweed Allergic | Mean Change From Baseline Patient-Assessed Ocular Itching, Area Under the Curve From Time Zero to Hour 3 [AUC (0-3)], Patanol and Placebo | Change | -2.146 hours x units on a scale | Standard Deviation 1.913 |
| Maxidex/Ragweed Allergic | Mean Change From Baseline Patient-Assessed Ocular Itching, Area Under the Curve From Time Zero to Hour 3 [AUC (0-3)], Patanol and Placebo | Visit 5 (Day 8 of treatment) | 2.630 hours x units on a scale | Standard Deviation 1.877 |
| Tears Naturale II/Ragweed Allergic | Mean Change From Baseline Patient-Assessed Ocular Itching, Area Under the Curve From Time Zero to Hour 3 [AUC (0-3)], Patanol and Placebo | Baseline (Visit 2, pre-treatment) | 5.669 hours x units on a scale | Standard Deviation 2.062 |
| Tears Naturale II/Ragweed Allergic | Mean Change From Baseline Patient-Assessed Ocular Itching, Area Under the Curve From Time Zero to Hour 3 [AUC (0-3)], Patanol and Placebo | Change | -1.680 hours x units on a scale | Standard Deviation 2.065 |
| Tears Naturale II/Ragweed Allergic | Mean Change From Baseline Patient-Assessed Ocular Itching, Area Under the Curve From Time Zero to Hour 3 [AUC (0-3)], Patanol and Placebo | Visit 5 (Day 8 of treatment) | 3.990 hours x units on a scale | Standard Deviation 2.781 |
| Maxidex/Cat Allergic | Mean Change From Baseline Patient-Assessed Ocular Itching, Area Under the Curve From Time Zero to Hour 3 [AUC (0-3)], Patanol and Placebo | Visit 5 (Day 8 of treatment) | 2.881 hours x units on a scale | Standard Deviation 2.203 |
| Maxidex/Cat Allergic | Mean Change From Baseline Patient-Assessed Ocular Itching, Area Under the Curve From Time Zero to Hour 3 [AUC (0-3)], Patanol and Placebo | Baseline (Visit 2, pre-treatment) | 5.904 hours x units on a scale | Standard Deviation 2.224 |
| Maxidex/Cat Allergic | Mean Change From Baseline Patient-Assessed Ocular Itching, Area Under the Curve From Time Zero to Hour 3 [AUC (0-3)], Patanol and Placebo | Change | -3.023 hours x units on a scale | Standard Deviation 2.668 |
| Tears Naturale II/Cat Allergic | Mean Change From Baseline Patient-Assessed Ocular Itching, Area Under the Curve From Time Zero to Hour 3 [AUC (0-3)], Patanol and Placebo | Baseline (Visit 2, pre-treatment) | 5.654 hours x units on a scale | Standard Deviation 2.408 |
| Tears Naturale II/Cat Allergic | Mean Change From Baseline Patient-Assessed Ocular Itching, Area Under the Curve From Time Zero to Hour 3 [AUC (0-3)], Patanol and Placebo | Change | -3.068 hours x units on a scale | Standard Deviation 2.361 |
| Tears Naturale II/Cat Allergic | Mean Change From Baseline Patient-Assessed Ocular Itching, Area Under the Curve From Time Zero to Hour 3 [AUC (0-3)], Patanol and Placebo | Visit 5 (Day 8 of treatment) | 2.586 hours x units on a scale | Standard Deviation 2.181 |