Rhinitis, Allergic, Seasonal
Conditions
Keywords
ragweed, once daily, fexofenadine, fluticasone furoate, allergic rhinitis
Brief summary
The primary objective of the study is to compare nighttime symptom relief of fluticasone furoate nasal spray versus oral fexofenadine
Interventions
DRUGfluticasone furoate, fexofenadine
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent * Otherwise healthy outpatient with mountain cedar allergy * Male or eligible female Females of childbearing potential must commit to the consistent and correct use of an acceptable method of birth control * Age 12 years or older at Visit 2 * Diagnosis of seasonal allergic rhinitis (SAR) to mountain cedar * Adequate exposure to mountain cedar pollen * Ability to comply with study procedures * Literate
Exclusion criteria
* Significant concomitant medical conditions * Use of intranasal corticosteroids within four weeks prior to Visit 1; use of inhaled, oral, intramuscular, intravenous, ocular, and/or dermatological corticosteroid (with the exception of hydrocortisone cream/ointment, 1% or less) within eight weeks prior to Visit 1. * Use of other allergy medications within specific timeframes relative to Visit 1 * Use of other medications that may affect allergic rhinitis or its symptoms * Use of immunosuppressive medications eight weeks prior to screening and during the study * Immunotherapy patients who are not stable on current dose * Use of any medications that significantly alters the pharmacokinetics of fluticasone furoate or fexofenadine * Allergy/Intolerance to corticosteroids, antihistamines, or any excipients in the two products * Use of contact lenses * Recent clinical trial/experimental medication experience within 30 days of Visit 1 * Subject previously failed the 21-day screen period or failed to complete the treatment period * Positive or inconclusive pregnancy test or female who is breastfeeding * Employee or relative affiliation with investigational site * Current tobacco use * Active chickenpox or measles or exposure in the last 3 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in the Nighttime Symptom Score (NSS) | Baseline and Weeks 1-2 | Questions include: 1. Nasal congestion on awakening (Score: 0=none, 1=mild, 2=moderate, 3=severe); 2. Difficulty going to sleep (Score: 0=not at all, 1=little, 2=moderately, 3=very); 3. Nighttime awakenings (Score: 0=not at all, 1=once, 2=more than once, 3=felt like awake all night). The sum of the ratings for the three items comprises the NSS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Daytime Reflective Total Nasal Symptom Score (D-rTNSS) | Baseline and Weeks 1-2 | Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe. |
| Mean Change From Baseline in 24 Hour Reflective Total Nasal Symptom Score (24 Hour rTNSS) | Baseline and Weeks 1-2 | Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS).Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe. |
| Mean Change From Baseline in Nighttime Reflective Total Ocular Symptom Score (N-rTOSS) | Baseline and Weeks 1-2 | Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the 3 ocular symptoms comprised the total ocular symptom score (TOSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe. |
| Mean Change From Baseline in Daytime Reflective Total Ocular Symptom Score (D-rTOSS) | Baseline and Weeks 1-2 | Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the 3 ocular symptoms comprised the total ocular symptom score (TOSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe. |
| Mean Change From Baseline in 24 Hour Reflective Total Ocular Symptoms Score (rTOSS) | Baseline and Weeks 1-2 | Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the 3 ocular symptoms comprised the total ocular symptom score (TOSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe. |
| Mean Change From Baseline in Nighttime Reflective Total Nasal Symptom Score (N-rTNSS) | Baseline and Weeks 1-2 | Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe. |
| Mean Change From Baseline in Pre-Dose Instantaneous Total Ocular Symptom Score (iTOSS) | Baseline and Weeks 1-2 | Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the four ocular symptoms comprised the total nasal symptom score (TOSS).Instantaneous rating represented symptoms at the time of the assessment. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe. |
| Mean Change From Baseline in Morning Peak Nasal Inspiratory Flow (PNIF) | Baseline and Weeks 1-2 | Subjects used a portable hand-held inspiratory flow meter to measure and record PNIF in the morning prior to taking the study medication. Three measurements were taken and the highest measurement was recorded in the electronic diary. A positive change signifies improved nasal air flow. |
| Mean Change From Baseline in Evening Peak Nasal Inspiratory Flow (PNIF) | Baseline and Weeks 1-2 | Subjects used a portable hand-held inspiratory flow meter to measure and record PNIF in the evening. Three measurements were taken and the highest measurement was recorded in the electronic diary. A positive change signifies improved nasal air flow. |
| Mean Change From Baseline at Day 15 for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) | Baseline, Day 15 or if Early Withdrawal Day | Subjects completed the 16-item Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)to assess nocturnal rhinitis-related quality of life. The NRQLQ measures the functional problems most troublesome to patients with nocturnal allergy symptoms. Each question scored from 0-6 with higher scores indicating more nocturnal impairment. |
| Mean Change From Baseline in Pre-Dose Instantaneous Total Nasal Symptom Score (iTNSS) | Baseline and Weeks 1-2 | Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS).Instantaneous rating represented symptoms at the time of the assessment. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo | 229 |
| Fluticasone Furoate 110mcg | 224 |
| Fexofenadine 180 mg | 227 |
| Total | 680 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 | 1 |
| Overall Study | Declining pollen counts | 0 | 1 | 1 |
| Overall Study | Logpad compliance <80% | 1 | 0 | 0 |
| Overall Study | Non-compliance | 0 | 2 | 2 |
| Overall Study | Non-compliance with eDiary | 4 | 1 | 1 |
| Overall Study | Outside pollen area more than 48 hours | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 5 | 2 |
| Overall Study | Randomized in error | 0 | 1 | 1 |
| Overall Study | Sponsor Terminated Study | 1 | 0 | 1 |
| Overall Study | Subject in jail | 0 | 1 | 0 |
| Overall Study | Subject took disallowed drug | 0 | 0 | 1 |
| Overall Study | Subject unable to swallow capsule | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 2 |
Baseline characteristics
| Characteristic | Placebo | Fluticasone Furoate 110mcg | Fexofenadine 180 mg | Total |
|---|---|---|---|---|
| Age, Continuous | 34.8 Years STANDARD_DEVIATION 12.71 | 34.0 Years STANDARD_DEVIATION 13.55 | 34.3 Years STANDARD_DEVIATION 13.66 | 34.4 Years STANDARD_DEVIATION 13.29 |
| Gender Female | 139 Participants | 152 Participants | 135 Participants | 426 Participants |
| Gender Male | 90 Participants | 72 Participants | 92 Participants | 254 Participants |
| Race/Ethnicity, Customized African American | 40 Number of Participants | 29 Number of Participants | 42 Number of Participants | 111 Number of Participants |
| Race/Ethnicity, Customized Other | 8 Number of Participants | 6 Number of Participants | 4 Number of Participants | 18 Number of Participants |
| Race/Ethnicity, Customized White | 181 Number of Participants | 189 Number of Participants | 181 Number of Participants | 551 Number of 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 | 27 / 229 | 31 / 224 | 37 / 227 |
| serious Total, serious adverse events | 0 / 229 | 0 / 224 | 1 / 227 |
Outcome results
Primary
Mean Change From Baseline in the Nighttime Symptom Score (NSS)
Questions include: 1. Nasal congestion on awakening (Score: 0=none, 1=mild, 2=moderate, 3=severe); 2. Difficulty going to sleep (Score: 0=not at all, 1=little, 2=moderately, 3=very); 3. Nighttime awakenings (Score: 0=not at all, 1=once, 2=more than once, 3=felt like awake all night). The sum of the ratings for the three items comprises the NSS.
Time frame: Baseline and Weeks 1-2
Population: One analysis population was defined for this study, the Intent-to-Treat population. . The Intent-to-Treat (ITT) population included all subjects randomized to double-blind treatment. This population formed the basis for all summaries of demographic, background, efficacy, and safety data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in the Nighttime Symptom Score (NSS) | -2.3 Score on a Scale | Standard Error 0.11 |
| Fluticasone Furoate 110mcg | Mean Change From Baseline in the Nighttime Symptom Score (NSS) | -3.1 Score on a Scale | Standard Error 0.12 |
| Fexofenadine 180 mg | Mean Change From Baseline in the Nighttime Symptom Score (NSS) | -2.2 Score on a Scale | Standard Error 0.12 |
Comparison: The primary efficacy measure, mean change from baseline over the two-week treatment period in NSS compared between fluticasone furoate and fexofenadine, was assessed at a significance level of α=0.05. If the null hypothesis of this comparison was rejected, then the secondary measures were subject to hypothesis testing. The study was powered at 90%.p-value: <0.00195% CI: [-1.2, -0.6]ANCOVA
p-value: <0.00195% CI: [-1.1, -0.4]ANCOVA
p-value: 0.37495% CI: [-0.2, 0.5]ANCOVA
Secondary
Mean Change From Baseline at Day 15 for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)
Subjects completed the 16-item Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)to assess nocturnal rhinitis-related quality of life. The NRQLQ measures the functional problems most troublesome to patients with nocturnal allergy symptoms. Each question scored from 0-6 with higher scores indicating more nocturnal impairment.
Time frame: Baseline, Day 15 or if Early Withdrawal Day
Population: Ten placebo subjects, six FFNS subjects, and four fexofenadine subjects had no overall NRQLQ score at endpoint, indicating either a missing score for one or more of the NRQLQ domains, a missing baseline score, or both. One additional FFNS patient had no on-treatment NRQLQ data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline at Day 15 for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) | -1.4 Score on a Scale | Standard Error 0.09 |
| Fluticasone Furoate 110mcg | Mean Change From Baseline at Day 15 for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) | -2.0 Score on a Scale | Standard Error 0.1 |
| Fexofenadine 180 mg | Mean Change From Baseline at Day 15 for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) | -1.4 Score on a Scale | Standard Error 0.1 |
Secondary
Mean Change From Baseline in 24 Hour Reflective Total Nasal Symptom Score (24 Hour rTNSS)
Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS).Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
Time frame: Baseline and Weeks 1-2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in 24 Hour Reflective Total Nasal Symptom Score (24 Hour rTNSS) | -2.8 Score on a Scale | Standard Error 0.14 |
| Fluticasone Furoate 110mcg | Mean Change From Baseline in 24 Hour Reflective Total Nasal Symptom Score (24 Hour rTNSS) | -4.1 Score on a Scale | Standard Error 0.18 |
| Fexofenadine 180 mg | Mean Change From Baseline in 24 Hour Reflective Total Nasal Symptom Score (24 Hour rTNSS) | -2.8 Score on a Scale | Standard Error 0.16 |
Secondary
Mean Change From Baseline in 24 Hour Reflective Total Ocular Symptoms Score (rTOSS)
Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the 3 ocular symptoms comprised the total ocular symptom score (TOSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
Time frame: Baseline and Weeks 1-2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in 24 Hour Reflective Total Ocular Symptoms Score (rTOSS) | -2.3 Score on a Scale | Standard Error 0.13 |
| Fluticasone Furoate 110mcg | Mean Change From Baseline in 24 Hour Reflective Total Ocular Symptoms Score (rTOSS) | -2.7 Score on a Scale | Standard Error 0.14 |
| Fexofenadine 180 mg | Mean Change From Baseline in 24 Hour Reflective Total Ocular Symptoms Score (rTOSS) | -2.2 Score on a Scale | Standard Error 0.13 |
Secondary
Mean Change From Baseline in Daytime Reflective Total Nasal Symptom Score (D-rTNSS)
Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
Time frame: Baseline and Weeks 1-2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Daytime Reflective Total Nasal Symptom Score (D-rTNSS) | -3.0 Score on a Scale | Standard Error 0.15 |
| Fluticasone Furoate 110mcg | Mean Change From Baseline in Daytime Reflective Total Nasal Symptom Score (D-rTNSS) | -4.2 Score on a Scale | Standard Error 0.18 |
| Fexofenadine 180 mg | Mean Change From Baseline in Daytime Reflective Total Nasal Symptom Score (D-rTNSS) | -2.9 Score on a Scale | Standard Error 0.16 |
Secondary
Mean Change From Baseline in Daytime Reflective Total Ocular Symptom Score (D-rTOSS)
Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the 3 ocular symptoms comprised the total ocular symptom score (TOSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
Time frame: Baseline and Weeks 1-2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Daytime Reflective Total Ocular Symptom Score (D-rTOSS) | -2.5 Score on a Scale | Standard Error 0.13 |
| Fluticasone Furoate 110mcg | Mean Change From Baseline in Daytime Reflective Total Ocular Symptom Score (D-rTOSS) | -2.9 Score on a Scale | Standard Error 0.14 |
| Fexofenadine 180 mg | Mean Change From Baseline in Daytime Reflective Total Ocular Symptom Score (D-rTOSS) | -2.4 Score on a Scale | Standard Error 0.13 |
Secondary
Mean Change From Baseline in Evening Peak Nasal Inspiratory Flow (PNIF)
Subjects used a portable hand-held inspiratory flow meter to measure and record PNIF in the evening. Three measurements were taken and the highest measurement was recorded in the electronic diary. A positive change signifies improved nasal air flow.
Time frame: Baseline and Weeks 1-2
Population: Two subjects in the placebo group \& two in the FFNS group recorded no data during the two-week treatment period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Evening Peak Nasal Inspiratory Flow (PNIF) | 2.3 Score on a Scale | Standard Error 1.38 |
| Fluticasone Furoate 110mcg | Mean Change From Baseline in Evening Peak Nasal Inspiratory Flow (PNIF) | 9.7 Score on a Scale | Standard Error 1.73 |
| Fexofenadine 180 mg | Mean Change From Baseline in Evening Peak Nasal Inspiratory Flow (PNIF) | 0.3 Score on a Scale | Standard Error 1.37 |
Secondary
Mean Change From Baseline in Morning Peak Nasal Inspiratory Flow (PNIF)
Subjects used a portable hand-held inspiratory flow meter to measure and record PNIF in the morning prior to taking the study medication. Three measurements were taken and the highest measurement was recorded in the electronic diary. A positive change signifies improved nasal air flow.
Time frame: Baseline and Weeks 1-2
Population: Two subjects in the placebo group \& three in the FFNS group recorded no data during the two-week treatment period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Morning Peak Nasal Inspiratory Flow (PNIF) | 4.8 Score on a Scale | Standard Error 1.27 |
| Fluticasone Furoate 110mcg | Mean Change From Baseline in Morning Peak Nasal Inspiratory Flow (PNIF) | 13.0 Score on a Scale | Standard Error 1.61 |
| Fexofenadine 180 mg | Mean Change From Baseline in Morning Peak Nasal Inspiratory Flow (PNIF) | 2.2 Score on a Scale | Standard Error 1.21 |
Secondary
Mean Change From Baseline in Nighttime Reflective Total Nasal Symptom Score (N-rTNSS)
Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
Time frame: Baseline and Weeks 1-2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Nighttime Reflective Total Nasal Symptom Score (N-rTNSS) | -2.9 Score on a Scale | Standard Error 0.15 |
| Fluticasone Furoate 110mcg | Mean Change From Baseline in Nighttime Reflective Total Nasal Symptom Score (N-rTNSS) | -4.1 Score on a Scale | Standard Error 0.17 |
| Fexofenadine 180 mg | Mean Change From Baseline in Nighttime Reflective Total Nasal Symptom Score (N-rTNSS) | -2.9 Score on a Scale | Standard Error 0.16 |
Secondary
Mean Change From Baseline in Nighttime Reflective Total Ocular Symptom Score (N-rTOSS)
Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the 3 ocular symptoms comprised the total ocular symptom score (TOSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
Time frame: Baseline and Weeks 1-2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Nighttime Reflective Total Ocular Symptom Score (N-rTOSS) | -2.3 Score on a Scale | Standard Error 0.13 |
| Fluticasone Furoate 110mcg | Mean Change From Baseline in Nighttime Reflective Total Ocular Symptom Score (N-rTOSS) | -2.7 Score on a Scale | Standard Error 0.14 |
| Fexofenadine 180 mg | Mean Change From Baseline in Nighttime Reflective Total Ocular Symptom Score (N-rTOSS) | -2.2 Score on a Scale | Standard Error 0.13 |
Secondary
Mean Change From Baseline in Pre-Dose Instantaneous Total Nasal Symptom Score (iTNSS)
Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS).Instantaneous rating represented symptoms at the time of the assessment. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
Time frame: Baseline and Weeks 1-2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Pre-Dose Instantaneous Total Nasal Symptom Score (iTNSS) | -2.8 Score on a Scale | Standard Error 0.15 |
| Fluticasone Furoate 110mcg | Mean Change From Baseline in Pre-Dose Instantaneous Total Nasal Symptom Score (iTNSS) | -4.1 Score on a Scale | Standard Error 0.18 |
| Fexofenadine 180 mg | Mean Change From Baseline in Pre-Dose Instantaneous Total Nasal Symptom Score (iTNSS) | -2.7 Score on a Scale | Standard Error 0.17 |
Secondary
Mean Change From Baseline in Pre-Dose Instantaneous Total Ocular Symptom Score (iTOSS)
Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the four ocular symptoms comprised the total nasal symptom score (TOSS).Instantaneous rating represented symptoms at the time of the assessment. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
Time frame: Baseline and Weeks 1-2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Pre-Dose Instantaneous Total Ocular Symptom Score (iTOSS) | -2.2 Score on a Scale | Standard Error 0.13 |
| Fluticasone Furoate 110mcg | Mean Change From Baseline in Pre-Dose Instantaneous Total Ocular Symptom Score (iTOSS) | -2.7 Score on a Scale | Standard Error 0.14 |
| Fexofenadine 180 mg | Mean Change From Baseline in Pre-Dose Instantaneous Total Ocular Symptom Score (iTOSS) | -2.2 Score on a Scale | Standard Error 0.14 |