A Phase 4 interventional study of Dexamethasone 0.1% ophthalmic suspension and Olopatadine hydrochloride 0.1% ophthalmic solution in Allergic Conjunctivitis, sponsored by Alcon Research. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2014-02-28.
Sponsored by Alcon Research (part of Alcon) · Phase 4, Interventional, and Diagnostic
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.
231 studies on the registry are indexed under Conjunctivitis, Allergic; 19 are open to participants now.
This study's enrollment of 180 is above the median of 85 across 192 interventional studies indexed under Conjunctivitis, Allergic.
Browse Conjunctivitis, Allergic studies →Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.
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Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\]
Drug: Dexamethasone 0.1% ophthalmic suspension
Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\]
Drug: Olopatadine hydrochloride 0.1% ophthalmic solution
Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\]
Other: Inactive ingredients, used as placebo
Maxidex
Patanol
Tears Naturale II
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)
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)
Patients were recruited from one study center in Canada.
| Milestone | Maxidex/Ragweed Allergic | Patanol/Ragweed Allergic | Tears Naturale II/Ragweed Allergic | Maxidex/Cat Allergic | Patanol/Cat Allergic | Tears Naturale II/Cat Allergic |
|---|---|---|---|---|---|---|
| Started | 26 | 24 | 26 | 31 | 31 | 32 |
| Completed | 26 | 24 | 24 | 29 | 30 | 32 |
| Not completed | 0 | 0 | 2 | 2 | 1 | 0 |
| Withdrew: Patient decision, not related to ae | 0 | 0 | 2 | 2 | 1 | 0 |
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.
| hours x units on a scale | Maxidex/Ragweed Allergic | Tears Naturale II/Ragweed Allergic | Maxidex/Cat Allergic | Tears Naturale II/Cat Allergic |
|---|---|---|---|---|
| Baseline (Visit 3, pre-treatment) | 18.120 ± 6.260 | 19.362 ± 7.666 | 16.823 ± 5.530 | 17.572 ± 6.803 |
| Visit 6 (Day 9 of treatment) | 11.671 ± 5.983 | 15.786 ± 6.514 | 11.313 ± 3.943 | 13.824 ± 4.792 |
| Change | -6.450 ± 7.002 | -3.576 ± 6.959 | -5.511 ± 5.916 | -3.748 ± 6.351 |
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.
| hours x units on a scale | Patanol/Ragweed Allergic | Tears Naturale II/Ragweed Allergic | Patanol/Cat Allergic | Tears Naturale II/Cat Allergic |
|---|---|---|---|---|
| Baseline (Visit 2, pre-treatment) | 4.776 ± 1.759 | 5.669 ± 2.062 | 5.904 ± 2.224 | 5.654 ± 2.408 |
| Visit 5 (Day 8 of treatment) | 2.630 ± 1.877 | 3.990 ± 2.781 | 2.881 ± 2.203 | 2.586 ± 2.181 |
| Change | -2.146 ± 1.913 | -1.680 ± 2.065 | -3.023 ± 2.668 | -3.068 ± 2.361 |
Collected over Adverse events were collected for the duration of the study (5 months, 29 days).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Maxidex | — | 0/57 (0%) | 13/57 (22.8%) |
| Patanol | — | 0/55 (0%) | 7/55 (12.7%) |
| Tears Naturale II | — | 0/58 (0%) | 7/58 (12.1%) |
| Event | Maxidex | Patanol | Tears Naturale II |
|---|---|---|---|
| Eye painEye disorders | 5/57 | 0/55 | 0/58 |
| Eye irritationEye disorders | 4/57 | 4/55 | 4/58 |
| HeadacheNervous system disorders | 4/57 | 3/55 | 3/58 |
| Age, Continuous(years) | Maxidex/Ragweed Allergic | Patanol/Ragweed Allergic | Tears Naturale II/Ragweed Allergic | Maxidex/Cat Allergic | Patanol/Cat Allergic | Tears Naturale II/Cat Allergic | Total |
|---|---|---|---|---|---|---|---|
| Mean | 34.0 ± 9.6 | 39.2 ± 13.8 | 40.0 ± 10.0 | 34.5 ± 11.6 | 32.9 ± 9.3 | 35.9 ± 8.4 | 35.91 ± 10.62 |
| Sex: Female, Male(Participants) | Maxidex/Ragweed Allergic | Patanol/Ragweed Allergic | Tears Naturale II/Ragweed Allergic | Maxidex/Cat Allergic | Patanol/Cat Allergic | Tears Naturale II/Cat Allergic | Total |
|---|---|---|---|---|---|---|---|
| Female | 11 | 13 | 17 | 23 | 22 | 24 | 110 |
| Male | 15 | 11 | 9 | 8 | 9 | 8 | 60 |
| Region of Enrollment(participants) | Maxidex/Ragweed Allergic | Patanol/Ragweed Allergic | Tears Naturale II/Ragweed Allergic | Maxidex/Cat Allergic | Patanol/Cat Allergic | Tears Naturale II/Cat Allergic | Total |
|---|---|---|---|---|---|---|---|
| Canada | 26 | 24 | 26 | 31 | 31 | 32 | 170 |
This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Dexamethasone · Olopatadine