Trial Outcomes & Findings for Assessing the Efficacy of Maxidex® and Patanol® for the Treatment of Allergic Conjunctivitis (NCT NCT01119287)
NCT ID: NCT01119287
Last Updated: 2014-02-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
180 participants
Primary outcome timeframe
Baseline (Visit 3, pre-treatment); Visit 6 (Day 9 of treatment)
Results posted on
2014-02-28
Participant Flow
Patients were recruited from one study center in Canada.
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.
Participant milestones
| Measure |
Maxidex/Ragweed Allergic
Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\]
|
Patanol/Ragweed Allergic
Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\]
|
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 \[Visit 4 through Visit 6 morning only\]
|
Maxidex/Cat Allergic
Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\]
|
Patanol/Cat Allergic
Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\]
|
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 \[Visit 4 through Visit 6 morning only\]
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
26
|
24
|
26
|
31
|
31
|
32
|
|
Overall Study
COMPLETED
|
26
|
24
|
24
|
29
|
30
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
2
|
1
|
0
|
Reasons for withdrawal
| Measure |
Maxidex/Ragweed Allergic
Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\]
|
Patanol/Ragweed Allergic
Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\]
|
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 \[Visit 4 through Visit 6 morning only\]
|
Maxidex/Cat Allergic
Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\]
|
Patanol/Cat Allergic
Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\]
|
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 \[Visit 4 through Visit 6 morning only\]
|
|---|---|---|---|---|---|---|
|
Overall Study
Patient Decision, not related to AE
|
0
|
0
|
2
|
2
|
1
|
0
|
Baseline Characteristics
Assessing the Efficacy of Maxidex® and Patanol® for the Treatment of Allergic Conjunctivitis
Baseline characteristics by cohort
| Measure |
Maxidex/Ragweed Allergic
n=26 Participants
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/Ragweed Allergic
n=24 Participants
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/Ragweed Allergic
n=26 Participants
Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\]
|
Maxidex/Cat Allergic
n=31 Participants
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/Cat Allergic
n=31 Participants
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/Cat Allergic
n=32 Participants
Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\]
|
Total
n=170 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
34.0 years
STANDARD_DEVIATION 9.6 • n=99 Participants
|
39.2 years
STANDARD_DEVIATION 13.8 • n=107 Participants
|
40.0 years
STANDARD_DEVIATION 10.0 • n=206 Participants
|
34.5 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
32.9 years
STANDARD_DEVIATION 9.3 • n=31 Participants
|
35.9 years
STANDARD_DEVIATION 8.4 • n=30 Participants
|
35.91 years
STANDARD_DEVIATION 10.62 • n=3 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
22 Participants
n=31 Participants
|
24 Participants
n=30 Participants
|
110 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
60 Participants
n=3 Participants
|
|
Region of Enrollment
Canada
|
26 participants
n=99 Participants
|
24 participants
n=107 Participants
|
26 participants
n=206 Participants
|
31 participants
n=7 Participants
|
31 participants
n=31 Participants
|
32 participants
n=30 Participants
|
170 participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Baseline (Visit 3, pre-treatment); Visit 6 (Day 9 of treatment)Population: Number of subjects with data available in the specific treatment group
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.
Outcome measures
| Measure |
Maxidex/Ragweed Allergic
n=26 Participants
Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\]
|
Tears Naturale II/Ragweed Allergic
n=24 Participants
Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\]
|
Maxidex/Cat Allergic
n=29 Participants
Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\]
|
Tears Naturale II/Cat Allergic
n=32 Participants
Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\]
|
|---|---|---|---|---|
|
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
|
-3.576 hours x units on a scale
Standard Deviation 6.959
|
-5.511 hours x units on a scale
Standard Deviation 5.916
|
-3.748 hours x units on a scale
Standard Deviation 6.351
|
|
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 6.260
|
19.362 hours x units on a scale
Standard Deviation 7.666
|
16.823 hours x units on a scale
Standard Deviation 5.530
|
17.572 hours x units on a scale
Standard Deviation 6.803
|
|
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
|
15.786 hours x units on a scale
Standard Deviation 6.514
|
11.313 hours x units on a scale
Standard Deviation 3.943
|
13.824 hours x units on a scale
Standard Deviation 4.792
|
PRIMARY outcome
Timeframe: Baseline (Visit 2, pre-treatment), Visit 5 (Day 8 of treatment)Population: Number of subjects with data available in the specific treatment group
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.
Outcome measures
| Measure |
Maxidex/Ragweed Allergic
n=24 Participants
Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\]
|
Tears Naturale II/Ragweed Allergic
n=24 Participants
Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\]
|
Maxidex/Cat Allergic
n=30 Participants
Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\]
|
Tears Naturale II/Cat Allergic
n=32 Participants
Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\]
|
|---|---|---|---|---|
|
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
|
5.669 hours x units on a scale
Standard Deviation 2.062
|
5.904 hours x units on a scale
Standard Deviation 2.224
|
5.654 hours x units on a scale
Standard Deviation 2.408
|
|
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
|
3.990 hours x units on a scale
Standard Deviation 2.781
|
2.881 hours x units on a scale
Standard Deviation 2.203
|
2.586 hours x units on a scale
Standard Deviation 2.181
|
|
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
|
-1.680 hours x units on a scale
Standard Deviation 2.065
|
-3.023 hours x units on a scale
Standard Deviation 2.668
|
-3.068 hours x units on a scale
Standard Deviation 2.361
|
Adverse Events
Maxidex
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Patanol
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Tears Naturale II
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Maxidex
n=57 participants at risk
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
n=55 participants at risk
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
n=58 participants at risk
Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\]
|
|---|---|---|---|
|
Eye disorders
Eye irritation
|
7.0%
4/57 • 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.
|
7.3%
4/55 • 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.
|
6.9%
4/58 • 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.
|
|
Eye disorders
Eye pain
|
8.8%
5/57 • 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.
|
0.00%
0/55 • 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.
|
0.00%
0/58 • 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.
|
|
Nervous system disorders
Headache
|
7.0%
4/57 • 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.
|
5.5%
3/55 • 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.
|
5.2%
3/58 • 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.
|
Additional Information
Head, Alcon Clinical
Alcon Research
Phone: 1-888-451-3937
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER