Allergic Conjunctivitis
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of ST266 ophthalmic drops compared to placebo for the treatment of the signs and symptoms of allergic conjunctivitis.
Detailed description
The study is a multi-center, double-masked, randomized, placebo-controlled, modified conjunctival allergen challenge (CAC) model. The primary endpoints of ocular itching and conjunctival redness will be evaluated at the subject's final visit. Subjects who meet inclusion criteria will be randomized to one of two treatment groups (1:1). Randomization will be stratified by average post-CAC itching scores at baseline. Subjects will be evaluated at baseline and on Days 6, 7 and 8.
Interventions
BIOLOGICALST266
One (1) drop of 1X ST266 ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
DRUGSaline (0.9% NaCl)
One (1) drop of saline ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
Sponsors
Noveome Biotherapeutics, formerly Stemnion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* be at least 18 years of age of either gender and any race; * provide written informed consent and sign the HIPAA form; * be willing and able to follow all instructions and attend all study visits; have a positive history of ocular allergies and a positive skin test reaction to a seasonal AND perennial allergen as confirmed by an allergic skin test; * be able and willing to avoid all disallowed medication for the appropriate washout period and during the study; * be able and willing to discontinue wearing contact lenses for at least 72 hours prior to and during the study trial period; * (for females capable of becoming pregnant) agree to have urine pregnancy testing performed at screening (must be negative) and at the study exit; must not be lactating; and must agree to use a medically acceptable form of birth control throughout the study duration and for at least 14 days prior to instillation of investigational product). Women considered capable of becoming pregnant include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy); * have a calculated visual acuity of 0.7 logMAR or better in each eye as measured using an ETDRS chart; * have a positive post-CAC reaction; * have a positive post-CAC reaction in two out of the first three time points; * be able to self-administer eye drops satisfactorily or have a caregiver at home routinely available for this purpose.
Exclusion criteria
* have known contraindications or sensitivities to the use of the investigational product or any of its components; * have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including but not limited to narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, or pterygium); * have had ocular surgical intervention within 3 months prior to initiating the study or during the study and/or a history of refractive surgery within the past 6 months; * have a known history of retinal detachment, diabetic retinopathy, or active retinal disease; * have the presence of an active ocular infection (bacterial, viral or fungal) or positive history of an ocular herpetic infection at any visit; * use any of the disallowed medications during the period indicated prior to and during the study; * have any significant illness (e.g. any autoimmune disease requiring therapy, severe cardiovascular disease \[including arrhythmias\]) the investigator feels could be expected to interfere with the subject's health or with the study parameters and/or put the subject at any unnecessary risk (includes but is not limited to: poorly controlled hypertension or poorly controlled diabetes, a history of status asthmaticus, organ transplants, a known history of persistent moderate or severe asthma, or a known history of moderate to severe allergic asthmatic reactions to any of the study allergens); * manifest signs or symptoms of clinically active allergic conjunctivitis in either eye at the screening visit; * have planned surgery (ocular or systemic) during the trial period or within 30 days after; * have used an investigational drug or medical device within 30 days of the study or be concurrently enrolled in another investigational product trial; * be a female who is currently pregnant, planning a pregnancy, or lactating. * have cancer or have a history of cancer within the last 5 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Itching | Day 7 and 8 | Ocular itching evaluated by the subject. Ocular itching was evaluated on a 0-4 scale (with half unit increments allowed). Lower scores indicated less itching. |
| Conjunctival Redness | Day 7 and 8 | Conjunctival redness evaluated by the investigator. Conjunctival redness was evaluated on a 0-4 scale (with half unit increments allowed). Lower scores indicated less redness. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chemosis | Day 7 and 8 | Chemosis evaluated by the investigator. Chemosis was evaluated on a 0-4 scale (with half unit increments allowed). A lower score was indicative of less chemosis. |
| Eyelid Swelling | Day 7 and 8 | Eyelid swelling evaluated by the subject. Eyelid swelling was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less swelling. |
| Tearing/Watery Eyes | Day 7 and 8 | Tearing evaluated by the subject. Tearing was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less tearing. |
| Rhinorrhea | Day 7 and 8 | Rhinorrhea evaluated by the subject. Rhinorrhea was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less severity. |
| Ciliary Redness | Day 7 and 8 | Ciliary redness evaluated by the investigator. Ciliary redness was evaluated on a 0-4 scale (with half unit increments allowed). A lower score was indicative of less redness. |
| Ear or Palate Pruritus | Day 7 and 8 | Ear or palate pruritus evaluated by the subject. Ear or palate pruritus was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less severity. |
| Nasal Congestion | Day 7 and 8 | Nasal congestion evaluated by the subject. Nasal congestion was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less severity. |
| Nasal Composite Score | Day 7 and 8 | A composite score of presence or absence of at least one nasal symptom evaluated by the subject |
| Nasal Pruritus | Day 7 and 8 | Nasal Pruritus evaluated by the subject. Nasal pruritus was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less severity. |
| Episcleral Redness | Day 7 and 8 | Episcleral redness evaluated by the investigator. Episcleral redness was evaluated on a 0-4 scale (with half unit increments allowed). A lower score was indicative of less redness. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 1X ST266 dosed 4 times a day for 8 days
ST266: One (1) drop of 1X ST266 ophthalmic eye drops will be administered to each eye 4 times a day for 8 days. | 34 |
| Group 2 Placebo dosed 4 times a day for 8 days
Saline (0.9% NaCl): One (1) drop of saline ophthalmic eye drops will be administered to each eye 4 times a day for 8 days. | 36 |
| Total | 70 |
Baseline characteristics
| Characteristic | Group 2 | Total | Group 1 |
|---|---|---|---|
| Age, Continuous | 47 years STANDARD_DEVIATION 13.98 | 45.3 years STANDARD_DEVIATION 13.74 | 43.5 years STANDARD_DEVIATION 13.44 |
| Allergen Disposition Cat Dander | 11 Participants | 22 Participants | 11 Participants |
| Allergen Disposition Cockroach | 4 Participants | 5 Participants | 1 Participants |
| Allergen Disposition Dog Dander | 5 Participants | 9 Participants | 4 Participants |
| Allergen Disposition Dust Mite | 16 Participants | 34 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 8 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 62 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Iris Color Black | 0 eyes | 0 eyes | 0 eyes |
| Iris Color Blue | 20 eyes | 30 eyes | 10 eyes |
| Iris Color Brown | 44 eyes | 86 eyes | 42 eyes |
| Iris Color Green | 6 eyes | 14 eyes | 8 eyes |
| Iris Color Hazel | 2 eyes | 10 eyes | 8 eyes |
| Iris Color Other | 0 eyes | 0 eyes | 0 eyes |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 19 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 24 Participants | 49 Participants | 25 Participants |
| Sex: Female, Male Female | 22 Participants | 41 Participants | 19 Participants |
| Sex: Female, Male Male | 14 Participants | 29 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 36 |
| other Total, other adverse events | 2 / 34 | 3 / 36 |
| serious Total, serious adverse events | 0 / 34 | 0 / 36 |
Outcome results
Primary
Conjunctival Redness
Conjunctival redness evaluated by the investigator. Conjunctival redness was evaluated on a 0-4 scale (with half unit increments allowed). Lower scores indicated less redness.
Time frame: Day 7 and 8
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 | Conjunctival Redness | Day 7, Pre-Conjunctival Allergen Challenge | 1.103 score on a scale | Standard Deviation 0.7541 |
| Group 1 | Conjunctival Redness | Day 8, Pre-Conjunctival Allergen Challenge | 0.912 score on a scale | Standard Deviation 0.6682 |
| Group 1 | Conjunctival Redness | Day 7, 15 Minutes Post Conjunctival Allergen Challenge | 1.897 score on a scale | Standard Deviation 0.9714 |
| Group 1 | Conjunctival Redness | Day 8, 10 Minutes Post Conjunctival Allergen Challenge | 1.963 score on a scale | Standard Deviation 0.7909 |
| Group 1 | Conjunctival Redness | Day 8, 30 Minutes Post Conjunctival Allergen Challenge | 1.596 score on a scale | Standard Deviation 0.8791 |
| Group 1 | Conjunctival Redness | Day 8, 15 Minutes Post Conjunctival Allergen Challenge | 1.963 score on a scale | Standard Deviation 0.8075 |
| Group 1 | Conjunctival Redness | Day 7, 20 Minutes Post Conjunctival Allergen Challenge | 1.926 score on a scale | Standard Deviation 1.0308 |
| Group 1 | Conjunctival Redness | Day 8, 20 Minutes Post Conjunctival Allergen Challenge | 1.882 score on a scale | Standard Deviation 0.8101 |
| Group 1 | Conjunctival Redness | Day 7, 10 Minutes Post Conjunctival Allergen Challenge | 2.125 score on a scale | Standard Deviation 0.8817 |
| Group 1 | Conjunctival Redness | Day 8, 25 Minutes Post Conjunctival Allergen Challenge | 1.735 score on a scale | Standard Deviation 0.8549 |
| Group 1 | Conjunctival Redness | Day 7, 30 Minutes Post Conjunctival Allergen Challenge | 1.816 score on a scale | Standard Deviation 1.0323 |
| Group 1 | Conjunctival Redness | Day 7, 25 Minutes Post Conjunctival Allergen Challenge | 1.875 score on a scale | Standard Deviation 1.0005 |
| Group 2 | Conjunctival Redness | Day 8, 30 Minutes Post Conjunctival Allergen Challenge | 1.625 score on a scale | Standard Deviation 0.7476 |
| Group 2 | Conjunctival Redness | Day 7, 25 Minutes Post Conjunctival Allergen Challenge | 1.743 score on a scale | Standard Deviation 0.8377 |
| Group 2 | Conjunctival Redness | Day 7, Pre-Conjunctival Allergen Challenge | 1.028 score on a scale | Standard Deviation 0.5818 |
| Group 2 | Conjunctival Redness | Day 7, 10 Minutes Post Conjunctival Allergen Challenge | 1.958 score on a scale | Standard Deviation 0.8814 |
| Group 2 | Conjunctival Redness | Day 7, 15 Minutes Post Conjunctival Allergen Challenge | 1.882 score on a scale | Standard Deviation 0.9073 |
| Group 2 | Conjunctival Redness | Day 7, 20 Minutes Post Conjunctival Allergen Challenge | 1.771 score on a scale | Standard Deviation 0.8481 |
| Group 2 | Conjunctival Redness | Day 7, 30 Minutes Post Conjunctival Allergen Challenge | 1.681 score on a scale | Standard Deviation 0.8775 |
| Group 2 | Conjunctival Redness | Day 8, Pre-Conjunctival Allergen Challenge | 0.819 score on a scale | Standard Deviation 0.4766 |
| Group 2 | Conjunctival Redness | Day 8, 10 Minutes Post Conjunctival Allergen Challenge | 1.917 score on a scale | Standard Deviation 0.7319 |
| Group 2 | Conjunctival Redness | Day 8, 15 Minutes Post Conjunctival Allergen Challenge | 2.111 score on a scale | Standard Deviation 0.787 |
| Group 2 | Conjunctival Redness | Day 8, 20 Minutes Post Conjunctival Allergen Challenge | 1.951 score on a scale | Standard Deviation 0.8036 |
| Group 2 | Conjunctival Redness | Day 8, 25 Minutes Post Conjunctival Allergen Challenge | 1.785 score on a scale | Standard Deviation 0.8241 |
Comparison: Day 7: Pre-CACp-value: 0.8165ANCOVA
Comparison: Day 7: 10 Minutes Post-CACp-value: 0.659ANCOVA
Comparison: Day 7: 15 Minutes Post-CACp-value: 0.7455ANCOVA
Comparison: Day 7: 20 Minutes Post-CACp-value: 0.9212ANCOVA
Comparison: Day 7: 25 Minutes Post-CACp-value: 0.9509ANCOVA
Comparison: Day 7: 30 Minutes Post-CACp-value: 0.7897ANCOVA
Comparison: Day 7: All Post-CAC Time Pointsp-value: 0.3183ANCOVA
Comparison: Day 8: Pre-CACp-value: 0.7604ANCOVA
Comparison: Day 8: 10 Minutes Post-CACp-value: 0.7343ANCOVA
Comparison: Day 8: 15 Minutes Post-CACp-value: 0.153ANCOVA
Comparison: Day 8: 20 Minutes Post-CACp-value: 0.3307ANCOVA
Comparison: Day 8: 25 Minutes Post-CACp-value: 0.3399ANCOVA
Comparison: Day 8: 30 Minutes Post-CACp-value: 0.5137ANCOVA
Comparison: Day 8: All Post-CAC Time Pointsp-value: 0.9962ANCOVA
Primary
Ocular Itching
Ocular itching evaluated by the subject. Ocular itching was evaluated on a 0-4 scale (with half unit increments allowed). Lower scores indicated less itching.
Time frame: Day 7 and 8
Population: Pre-Conjunctival Allergen Challenge not evaluated in subject 1-011 on visit 5B
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 | Ocular Itching | Day 8, 25 Minutes Post Conjunctival Allergen Challenge | 1.765 score on a scale | Standard Deviation 0.9573 |
| Group 1 | Ocular Itching | Day 8, 30 Minutes Post Conjunctival Allergen Challenge | 1.493 score on a scale | Standard Deviation 0.9262 |
| Group 1 | Ocular Itching | Day 7, Pre-Conjunctival Allergen Challenge | 0.508 score on a scale | Standard Deviation 0.8373 |
| Group 1 | Ocular Itching | Day 7, 5 Minutes Post Conjunctival Allergen Challenge | 2.485 score on a scale | Standard Deviation 0.9533 |
| Group 1 | Ocular Itching | Day 7, 7 Minutes Post Conjunctival Allergen Challenge | 2.559 score on a scale | Standard Deviation 0.9887 |
| Group 1 | Ocular Itching | Day 7, 10 Minutes Post Conjunctival Allergen Challenge | 2.434 score on a scale | Standard Deviation 0.932 |
| Group 1 | Ocular Itching | Day 7, 15 Minutes Post Conjunctival Allergen Challenge | 2.154 score on a scale | Standard Deviation 0.9415 |
| Group 1 | Ocular Itching | Day 7, 20 Minutes Post Conjunctival Allergen Challenge | 1.838 score on a scale | Standard Deviation 0.996 |
| Group 1 | Ocular Itching | Day 7, 25 Minutes Post Conjunctival Allergen Challenge | 1.529 score on a scale | Standard Deviation 0.9103 |
| Group 1 | Ocular Itching | Day 7, 30 Minutes Post Conjunctival Allergen Challenge | 1.346 score on a scale | Standard Deviation 0.9435 |
| Group 1 | Ocular Itching | Day 8, pre-Conjunctival Allergen Challenge | 0.449 score on a scale | Standard Deviation 0.7405 |
| Group 1 | Ocular Itching | Day 8, 5 Minutes Post Conjunctival Allergen Challenge | 2.816 score on a scale | Standard Deviation 0.8968 |
| Group 1 | Ocular Itching | Day 8, 7 Minutes Post Conjunctival Allergen Challenge | 2.787 score on a scale | Standard Deviation 0.9316 |
| Group 1 | Ocular Itching | Day 8, 10 Minutes Post Conjunctival Allergen Challenge | 2.588 score on a scale | Standard Deviation 0.9903 |
| Group 1 | Ocular Itching | Day 8, 15 Minutes Post Conjunctival Allergen Challenge | 2.309 score on a scale | Standard Deviation 0.9654 |
| Group 1 | Ocular Itching | Day 8, 20 Minutes Post Conjunctival Allergen Challenge | 2.081 score on a scale | Standard Deviation 0.9389 |
| Group 2 | Ocular Itching | Day 8, 20 Minutes Post Conjunctival Allergen Challenge | 1.986 score on a scale | Standard Deviation 1.1354 |
| Group 2 | Ocular Itching | Day 8, 25 Minutes Post Conjunctival Allergen Challenge | 1.819 score on a scale | Standard Deviation 1.1158 |
| Group 2 | Ocular Itching | Day 7, 25 Minutes Post Conjunctival Allergen Challenge | 1.722 score on a scale | Standard Deviation 1.1707 |
| Group 2 | Ocular Itching | Day 8, 30 Minutes Post Conjunctival Allergen Challenge | 1.590 score on a scale | Standard Deviation 1.1167 |
| Group 2 | Ocular Itching | Day 8, 7 Minutes Post Conjunctival Allergen Challenge | 2.625 score on a scale | Standard Deviation 0.9865 |
| Group 2 | Ocular Itching | Day 7, Pre-Conjunctival Allergen Challenge | 0.139 score on a scale | Standard Deviation 0.3131 |
| Group 2 | Ocular Itching | Day 7, 30 Minutes Post Conjunctival Allergen Challenge | 1.583 score on a scale | Standard Deviation 1.1164 |
| Group 2 | Ocular Itching | Day 7, 5 Minutes Post Conjunctival Allergen Challenge | 2.535 score on a scale | Standard Deviation 1.107 |
| Group 2 | Ocular Itching | Day 8, 15 Minutes Post Conjunctival Allergen Challenge | 2.299 score on a scale | Standard Deviation 1.0804 |
| Group 2 | Ocular Itching | Day 7, 7 Minutes Post Conjunctival Allergen Challenge | 2.576 score on a scale | Standard Deviation 1.1113 |
| Group 2 | Ocular Itching | Day 8, pre-Conjunctival Allergen Challenge | 0.167 score on a scale | Standard Deviation 0.3827 |
| Group 2 | Ocular Itching | Day 7, 10 Minutes Post Conjunctival Allergen Challenge | 2.458 score on a scale | Standard Deviation 1.1124 |
| Group 2 | Ocular Itching | Day 8, 10 Minutes Post Conjunctival Allergen Challenge | 2.604 score on a scale | Standard Deviation 1.0357 |
| Group 2 | Ocular Itching | Day 7, 15 Minutes Post Conjunctival Allergen Challenge | 2.181 score on a scale | Standard Deviation 1.152 |
| Group 2 | Ocular Itching | Day 8, 5 Minutes Post Conjunctival Allergen Challenge | 2.618 score on a scale | Standard Deviation 0.9847 |
| Group 2 | Ocular Itching | Day 7, 20 Minutes Post Conjunctival Allergen Challenge | 1.910 score on a scale | Standard Deviation 1.1482 |
Comparison: Day 7: Pre-CACp-value: 0.0882ANCOVA
Comparison: Day 7: 5 Minutes Post-CACp-value: 0.8032ANCOVA
Comparison: Day 7: 7 Minutes Post-CACp-value: 0.9003ANCOVA
Comparison: Day 7: 10 Minutes Post-CACp-value: 0.9523ANCOVA
Comparison: Day 7: 15 Minutes Post-CACp-value: 0.9071ANCOVA
Comparison: Day 7: 20 Minutes Post-CACp-value: 0.7509ANCOVA
Comparison: Day 7: 25 Minutes Post-CACp-value: 0.2824ANCOVA
Comparison: Day 7: 30 Minutes Post-CACp-value: 0.4017ANCOVA
Comparison: Day 7: All Post-CAC Time Pointsp-value: 0.4497ANCOVA
Comparison: Day 8: Pre-CACp-value: 0.165ANCOVA
Comparison: Day 8: 5 Minutes Post-CACp-value: 0.3494ANCOVA
Comparison: Day 8: 7 Minutes Post-CACp-value: 0.4781ANCOVA
Comparison: Day 8: 10 Minutes Post-CACp-value: 0.9847ANCOVA
Comparison: Day 8: 15 Minutes Post-CACp-value: 0.9731ANCOVA
Comparison: Day 8: 20 Minutes Post-CACp-value: 0.6984ANCOVA
Comparison: Day 8: 25 Minutes Post-CACp-value: 0.6265ANCOVA
Comparison: Day 8: 30 Minutes Post-CACp-value: 0.7848ANCOVA
Comparison: Day 8: All Post-CAC Time Pointsp-value: 0.5789ANCOVA
Secondary
Chemosis
Chemosis evaluated by the investigator. Chemosis was evaluated on a 0-4 scale (with half unit increments allowed). A lower score was indicative of less chemosis.
Time frame: Day 7 and 8
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 | Chemosis | Day 7, Pre-Conjunctival Allergen Challenge | 0.390 score on a scale | Standard Deviation 0.3703 |
| Group 1 | Chemosis | Day 7, 10 Minutes Post Conjunctival Allergen Challenge | 0.765 score on a scale | Standard Deviation 0.4306 |
| Group 1 | Chemosis | Day 7, 15 Minutes Post Conjunctival Allergen Challenge | 0.669 score on a scale | Standard Deviation 0.5391 |
| Group 1 | Chemosis | Day 7, 20 Minutes Post Conjunctival Allergen Challenge | 0.691 score on a scale | Standard Deviation 0.5709 |
| Group 1 | Chemosis | Day 7, 25 Minutes Post Conjunctival Allergen Challenge | 0.691 score on a scale | Standard Deviation 0.6001 |
| Group 1 | Chemosis | Day 7, 30 Minutes Post Conjunctival Allergen Challenge | 0.676 score on a scale | Standard Deviation 0.6047 |
| Group 1 | Chemosis | Day 8, pre-Conjunctival Allergen Challenge | 0.081 score on a scale | Standard Deviation 0.228 |
| Group 1 | Chemosis | Day 8, 10 Minutes Post Conjunctival Allergen Challenge | 0.574 score on a scale | Standard Deviation 0.6262 |
| Group 1 | Chemosis | Day 8, 15 Minutes Post Conjunctival Allergen Challenge | 0.632 score on a scale | Standard Deviation 0.7288 |
| Group 1 | Chemosis | Day 8, 20 Minutes Post Conjunctival Allergen Challenge | 0.684 score on a scale | Standard Deviation 0.7792 |
| Group 1 | Chemosis | Day 8, 25 Minutes Post Conjunctival Allergen Challenge | 0.566 score on a scale | Standard Deviation 0.7444 |
| Group 1 | Chemosis | Day 8, 30 Minutes Post Conjunctival Allergen Challenge | 0.551 score on a scale | Standard Deviation 0.8137 |
| Group 2 | Chemosis | Day 8, 25 Minutes Post Conjunctival Allergen Challenge | 0.590 score on a scale | Standard Deviation 0.5674 |
| Group 2 | Chemosis | Day 7, Pre-Conjunctival Allergen Challenge | 0.465 score on a scale | Standard Deviation 0.3787 |
| Group 2 | Chemosis | Day 8, pre-Conjunctival Allergen Challenge | 0.104 score on a scale | Standard Deviation 0.1925 |
| Group 2 | Chemosis | Day 7, 10 Minutes Post Conjunctival Allergen Challenge | 0.840 score on a scale | Standard Deviation 0.4711 |
| Group 2 | Chemosis | Day 8, 20 Minutes Post Conjunctival Allergen Challenge | 0.708 score on a scale | Standard Deviation 0.4571 |
| Group 2 | Chemosis | Day 7, 15 Minutes Post Conjunctival Allergen Challenge | 0.708 score on a scale | Standard Deviation 0.4762 |
| Group 2 | Chemosis | Day 8, 10 Minutes Post Conjunctival Allergen Challenge | 0.674 score on a scale | Standard Deviation 0.4994 |
| Group 2 | Chemosis | Day 7, 20 Minutes Post Conjunctival Allergen Challenge | 0.778 score on a scale | Standard Deviation 0.4259 |
| Group 2 | Chemosis | Day 8, 30 Minutes Post Conjunctival Allergen Challenge | 0.493 score on a scale | Standard Deviation 0.6196 |
| Group 2 | Chemosis | Day 7, 25 Minutes Post Conjunctival Allergen Challenge | 0.785 score on a scale | Standard Deviation 0.5146 |
| Group 2 | Chemosis | Day 8, 15 Minutes Post Conjunctival Allergen Challenge | 0.764 score on a scale | Standard Deviation 0.4265 |
| Group 2 | Chemosis | Day 7, 30 Minutes Post Conjunctival Allergen Challenge | 0.757 score on a scale | Standard Deviation 0.4075 |
Comparison: Day 7: Pre-CACp-value: 0.3322ANCOVA
Comparison: Day 7: 10 Minutes Pre-CACp-value: 0.8026ANCOVA
Comparison: Day 7: 15 Minutes Pre-CACp-value: 0.9981ANCOVA
Comparison: Day 7: 20 Minutes Post-CACp-value: 0.5645ANCOVA
Comparison: Day 7: 25 Minutes Post-CACp-value: 0.5455ANCOVA
Comparison: Day 7: 30 Minutes Post-CACp-value: 0.698ANCOVA
Comparison: Day 7: All Post-CAC Time Pointsp-value: 0.6115ANCOVA
Comparison: Day 8: Pre-CACp-value: 0.4528ANCOVA
Comparison: Day 8: 10 Minutes Post-CACp-value: 0.7551ANCOVA
Comparison: Day 8: 15 Minutes Post-CACp-value: 0.5318ANCOVA
Comparison: Day 8: 20 Minutes Post-CACp-value: 0.9748ANCOVA
Comparison: Day 8: 25 Minutes Post-CACp-value: 0.7706ANCOVA
Comparison: Day 8: 30 Minutes Post-CACp-value: 0.3414ANCOVA
Comparison: Day 8: All Post-CAC Time Pointsp-value: 0.4361ANCOVA
Secondary
Ciliary Redness
Ciliary redness evaluated by the investigator. Ciliary redness was evaluated on a 0-4 scale (with half unit increments allowed). A lower score was indicative of less redness.
Time frame: Day 7 and 8
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 | Ciliary Redness | Day 7, Pre-Conjunctival Allergen Challenge | 0.912 score on a scale | Standard Deviation 0.6243 |
| Group 1 | Ciliary Redness | Day 7, 10 Minutes Post Conjunctival Allergen Challenge | 1.838 score on a scale | Standard Deviation 0.8368 |
| Group 1 | Ciliary Redness | Day 7, 15 Minutes Post Conjunctival Allergen Challenge | 1.691 score on a scale | Standard Deviation 0.9925 |
| Group 1 | Ciliary Redness | Day 7, 20 Minutes Post Conjunctival Allergen Challenge | 1.713 score on a scale | Standard Deviation 0.9417 |
| Group 1 | Ciliary Redness | Day 7, 25 Minutes Post Conjunctival Allergen Challenge | 1.654 score on a scale | Standard Deviation 0.915 |
| Group 1 | Ciliary Redness | Day 7, 30 Minutes Post Conjunctival Allergen Challenge | 1.603 score on a scale | Standard Deviation 0.9869 |
| Group 1 | Ciliary Redness | Day 8, pre-Conjunctival Allergen Challenge | 0.581 score on a scale | Standard Deviation 0.6053 |
| Group 1 | Ciliary Redness | Day 8, 10 Minutes Post Conjunctival Allergen Challenge | 1.691 score on a scale | Standard Deviation 0.8189 |
| Group 1 | Ciliary Redness | Day 8, 15 Minutes Post Conjunctival Allergen Challenge | 1.699 score on a scale | Standard Deviation 0.7804 |
| Group 1 | Ciliary Redness | Day 8, 20 Minutes Post Conjunctival Allergen Challenge | 1.625 score on a scale | Standard Deviation 0.8556 |
| Group 1 | Ciliary Redness | Day 8, 25 Minutes Post Conjunctival Allergen Challenge | 1.463 score on a scale | Standard Deviation 0.9027 |
| Group 1 | Ciliary Redness | Day 8, 30 Minutes Post Conjunctival Allergen Challenge | 1.346 score on a scale | Standard Deviation 0.8528 |
| Group 2 | Ciliary Redness | Day 8, 25 Minutes Post Conjunctival Allergen Challenge | 1.569 score on a scale | Standard Deviation 0.7806 |
| Group 2 | Ciliary Redness | Day 7, Pre-Conjunctival Allergen Challenge | 0.750 score on a scale | Standard Deviation 0.5445 |
| Group 2 | Ciliary Redness | Day 8, pre-Conjunctival Allergen Challenge | 0.521 score on a scale | Standard Deviation 0.4487 |
| Group 2 | Ciliary Redness | Day 7, 10 Minutes Post Conjunctival Allergen Challenge | 1.799 score on a scale | Standard Deviation 0.8341 |
| Group 2 | Ciliary Redness | Day 8, 20 Minutes Post Conjunctival Allergen Challenge | 1.792 score on a scale | Standard Deviation 0.7688 |
| Group 2 | Ciliary Redness | Day 7, 20 Minutes Post Conjunctival Allergen Challenge | 1.625 score on a scale | Standard Deviation 0.842 |
| Group 2 | Ciliary Redness | Day 7, 15 Minutes Post Conjunctival Allergen Challenge | 1.729 score on a scale | Standard Deviation 0.8353 |
| Group 2 | Ciliary Redness | Day 8, 10 Minutes Post Conjunctival Allergen Challenge | 1.743 score on a scale | Standard Deviation 0.7058 |
| Group 2 | Ciliary Redness | Day 8, 30 Minutes Post Conjunctival Allergen Challenge | 1.458 score on a scale | Standard Deviation 0.8007 |
| Group 2 | Ciliary Redness | Day 7, 25 Minutes Post Conjunctival Allergen Challenge | 1.583 score on a scale | Standard Deviation 0.7488 |
| Group 2 | Ciliary Redness | Day 8, 15 Minutes Post Conjunctival Allergen Challenge | 1.931 score on a scale | Standard Deviation 0.731 |
| Group 2 | Ciliary Redness | Day 7, 30 Minutes Post Conjunctival Allergen Challenge | 1.493 score on a scale | Standard Deviation 0.8608 |
Comparison: Day 7: Pre-CACp-value: 0.3259ANCOVA
Comparison: Day 7: 10 Minutes Post-CACp-value: 0.9785ANCOVA
Comparison: Day 7: 15 Minutes Post-CACp-value: 0.5112ANCOVA
Comparison: Day 7: 20 Minutes Post-CACp-value: 0.7771ANCOVA
Comparison: Day 7: 25 Minutes Post-CACp-value: 0.6232ANCOVA
Comparison: Day 7: 30 Minutes Post-CACp-value: 0.8895ANCOVA
Comparison: Day 7: All Post-CAC Time Pointsp-value: 0.8974ANCOVA
Comparison: Day 8: Pre-CACp-value: 0.9604ANCOVA
Comparison: Day 8: 10 minutes Post-CACp-value: 0.5301ANCOVA
Comparison: Day 8: 15 Minutes Post-CACp-value: 0.0386ANCOVA
Comparison: Day 8: 20 Minutes Post-CACp-value: 0.1034ANCOVA
Comparison: Day 8: 25 Minutes Post-CACp-value: 0.0985ANCOVA
Comparison: Day 8: 30 Minutes Post-CACp-value: 0.2342ANCOVA
Comparison: Day 8: All Post-CAC Time Pointsp-value: 0.3016ANCOVA
Secondary
Ear or Palate Pruritus
Ear or palate pruritus evaluated by the subject. Ear or palate pruritus was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less severity.
Time frame: Day 7 and 8
Population: Pre-Conjunctival Allergen Challenge not evaluated in subject 1-011 on visit 5B
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 | Ear or Palate Pruritus | Day 7, 10 Minutes Post Conjunctival Allergen Challenge | 1.26 score on a scale | Standard Deviation 1.355 |
| Group 1 | Ear or Palate Pruritus | Day 8, pre-Conjunctival Allergen Challenge | 0.06 score on a scale | Standard Deviation 0.239 |
| Group 1 | Ear or Palate Pruritus | Day 8, 10 Minutes Post Conjunctival Allergen Challenge | 1.18 score on a scale | Standard Deviation 1.336 |
| Group 1 | Ear or Palate Pruritus | Day 7, 20 Minutes Post Conjunctival Allergen Challenge | 1.00 score on a scale | Standard Deviation 1.073 |
| Group 1 | Ear or Palate Pruritus | Day 8, 15 Minutes Post Conjunctival Allergen Challenge | 1.15 score on a scale | Standard Deviation 1.282 |
| Group 1 | Ear or Palate Pruritus | Day 7, Pre-Conjunctival Allergen Challenge | 0.33 score on a scale | Standard Deviation 0.595 |
| Group 1 | Ear or Palate Pruritus | Day 8, 20 Minutes Post Conjunctival Allergen Challenge | 1.12 score on a scale | Standard Deviation 1.274 |
| Group 1 | Ear or Palate Pruritus | Day 7, 25 Minutes Post Conjunctival Allergen Challenge | 0.91 score on a scale | Standard Deviation 0.965 |
| Group 1 | Ear or Palate Pruritus | Day 8, 25 Minutes Post Conjunctival Allergen Challenge | 1.00 score on a scale | Standard Deviation 1.181 |
| Group 1 | Ear or Palate Pruritus | Day 7, 15 Minutes Post Conjunctival Allergen Challenge | 1.18 score on a scale | Standard Deviation 1.193 |
| Group 1 | Ear or Palate Pruritus | Day 8, 30 Minutes Post Conjunctival Allergen Challenge | 1.00 score on a scale | Standard Deviation 1.128 |
| Group 1 | Ear or Palate Pruritus | Day 7, 30 Minutes Post Conjunctival Allergen Challenge | 0.88 score on a scale | Standard Deviation 0.808 |
| Group 2 | Ear or Palate Pruritus | Day 8, 30 Minutes Post Conjunctival Allergen Challenge | 0.97 score on a scale | Standard Deviation 1.253 |
| Group 2 | Ear or Palate Pruritus | Day 7, Pre-Conjunctival Allergen Challenge | 0.19 score on a scale | Standard Deviation 0.401 |
| Group 2 | Ear or Palate Pruritus | Day 7, 10 Minutes Post Conjunctival Allergen Challenge | 1.22 score on a scale | Standard Deviation 1.245 |
| Group 2 | Ear or Palate Pruritus | Day 7, 15 Minutes Post Conjunctival Allergen Challenge | 1.11 score on a scale | Standard Deviation 1.214 |
| Group 2 | Ear or Palate Pruritus | Day 7, 20 Minutes Post Conjunctival Allergen Challenge | 1.08 score on a scale | Standard Deviation 1.105 |
| Group 2 | Ear or Palate Pruritus | Day 7, 25 Minutes Post Conjunctival Allergen Challenge | 0.94 score on a scale | Standard Deviation 1.094 |
| Group 2 | Ear or Palate Pruritus | Day 7, 30 Minutes Post Conjunctival Allergen Challenge | 0.83 score on a scale | Standard Deviation 0.971 |
| Group 2 | Ear or Palate Pruritus | Day 8, 10 Minutes Post Conjunctival Allergen Challenge | 1.33 score on a scale | Standard Deviation 1.352 |
| Group 2 | Ear or Palate Pruritus | Day 8, 15 Minutes Post Conjunctival Allergen Challenge | 1.28 score on a scale | Standard Deviation 1.344 |
| Group 2 | Ear or Palate Pruritus | Day 8, 20 Minutes Post Conjunctival Allergen Challenge | 1.19 score on a scale | Standard Deviation 1.283 |
| Group 2 | Ear or Palate Pruritus | Day 8, 25 Minutes Post Conjunctival Allergen Challenge | 1.08 score on a scale | Standard Deviation 1.204 |
| Group 2 | Ear or Palate Pruritus | Day 8, pre-Conjunctival Allergen Challenge | 0.19 score on a scale | Standard Deviation 0.401 |
Comparison: Day 7: Pre-CACp-value: 0.1259ANCOVA
Comparison: Day 7: 10 Minutes Post-CACp-value: 0.9234ANCOVA
Comparison: Day 7: 15 Minutes Post-CACp-value: 0.8816ANCOVA
Comparison: Day 7: 20 Minutes Post-CACp-value: 0.5703ANCOVA
Comparison: Day 7: 25 Minutes Post-CACp-value: 0.5428ANCOVA
Comparison: Day 7: 30 Minutes Post-CACp-value: 0.7454ANCOVA
Comparison: Day 7: All Post-CAC Time Pointsp-value: 0.8195ANCOVA
Comparison: Day 8: Pre-CACp-value: 0.0909ANCOVA
Comparison: Day 8: 10 Minutes Post-CACp-value: 0.4881ANCOVA
Comparison: Day 8: 15 Minutes Post-CACp-value: 0.3391ANCOVA
Comparison: Day 8: 20 Minutes Post-CACp-value: 0.6065ANCOVA
Comparison: Day 8: 25 Minutes Post-CACp-value: 0.3393ANCOVA
Comparison: Day 8: 30 Minutes Post-CACp-value: 0.8364ANCOVA
Comparison: Day 8: All Post-CAC Time Pointsp-value: 0.8858ANCOVA
Secondary
Episcleral Redness
Episcleral redness evaluated by the investigator. Episcleral redness was evaluated on a 0-4 scale (with half unit increments allowed). A lower score was indicative of less redness.
Time frame: Day 7 and 8
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 | Episcleral Redness | Day 7, Pre-Conjunctival Allergen Challenge | 1.029 score on a scale | Standard Deviation 0.6622 |
| Group 1 | Episcleral Redness | Day 7, 10 Minutes Post Conjunctival Allergen Challenge | 1.868 score on a scale | Standard Deviation 0.8217 |
| Group 1 | Episcleral Redness | Day 7, 15 Minutes Post Conjunctival Allergen Challenge | 1.757 score on a scale | Standard Deviation 0.9283 |
| Group 1 | Episcleral Redness | Day 7, 20 Minutes Post Conjunctival Allergen Challenge | 1.787 score on a scale | Standard Deviation 0.9656 |
| Group 1 | Episcleral Redness | Day 7, 25 Minutes Post Conjunctival Allergen Challenge | 1.721 score on a scale | Standard Deviation 0.9939 |
| Group 1 | Episcleral Redness | Day 7, 30 Minutes Post Conjunctival Allergen Challenge | 1.669 score on a scale | Standard Deviation 1.0275 |
| Group 1 | Episcleral Redness | Day 8, pre-Conjunctival Allergen Challenge | 0.507 score on a scale | Standard Deviation 0.5822 |
| Group 1 | Episcleral Redness | Day 8, 10 Minutes Post Conjunctival Allergen Challenge | 1.735 score on a scale | Standard Deviation 0.821 |
| Group 1 | Episcleral Redness | Day 8, 15 Minutes Post Conjunctival Allergen Challenge | 1.706 score on a scale | Standard Deviation 0.8404 |
| Group 1 | Episcleral Redness | Day 8, 20 Minutes Post Conjunctival Allergen Challenge | 1.647 score on a scale | Standard Deviation 0.8144 |
| Group 1 | Episcleral Redness | Day 8, 25 Minutes Post Conjunctival Allergen Challenge | 1.412 score on a scale | Standard Deviation 0.868 |
| Group 1 | Episcleral Redness | Day 8, 30 Minutes Post Conjunctival Allergen Challenge | 1.353 score on a scale | Standard Deviation 0.8575 |
| Group 2 | Episcleral Redness | Day 8, 25 Minutes Post Conjunctival Allergen Challenge | 1.583 score on a scale | Standard Deviation 0.7488 |
| Group 2 | Episcleral Redness | Day 7, Pre-Conjunctival Allergen Challenge | 0.910 score on a scale | Standard Deviation 0.5579 |
| Group 2 | Episcleral Redness | Day 8, pre-Conjunctival Allergen Challenge | 0.424 score on a scale | Standard Deviation 0.4544 |
| Group 2 | Episcleral Redness | Day 7, 10 Minutes Post Conjunctival Allergen Challenge | 1.819 score on a scale | Standard Deviation 0.8401 |
| Group 2 | Episcleral Redness | Day 8, 20 Minutes Post Conjunctival Allergen Challenge | 1.701 score on a scale | Standard Deviation 0.7508 |
| Group 2 | Episcleral Redness | Day 7, 15 Minutes Post Conjunctival Allergen Challenge | 1.778 score on a scale | Standard Deviation 0.8468 |
| Group 2 | Episcleral Redness | Day 8, 10 Minutes Post Conjunctival Allergen Challenge | 1.708 score on a scale | Standard Deviation 0.6827 |
| Group 2 | Episcleral Redness | Day 7, 20 Minutes Post Conjunctival Allergen Challenge | 1.701 score on a scale | Standard Deviation 0.8036 |
| Group 2 | Episcleral Redness | Day 8, 30 Minutes Post Conjunctival Allergen Challenge | 1.347 score on a scale | Standard Deviation 0.7495 |
| Group 2 | Episcleral Redness | Day 7, 25 Minutes Post Conjunctival Allergen Challenge | 1.618 score on a scale | Standard Deviation 0.75 |
| Group 2 | Episcleral Redness | Day 8, 15 Minutes Post Conjunctival Allergen Challenge | 1.896 score on a scale | Standard Deviation 0.7055 |
| Group 2 | Episcleral Redness | Day 7, 30 Minutes Post Conjunctival Allergen Challenge | 1.583 score on a scale | Standard Deviation 0.8345 |
Comparison: Day 7: Pre-CACp-value: 0.4927ANCOVA
Comparison: Day 7: 10 minutes Post-CACp-value: 0.8686ANCOVA
Comparison: Day 7: 15 Minutes Post-CACp-value: 0.5772ANCOVA
Comparison: Day 7: 20 Minutes Post-CACp-value: 0.97ANCOVA
Comparison: Day 7: 25 Minutes Post-CACp-value: 0.7516ANCOVA
Comparison: Day 7: 30 Minutes Post-CACp-value: 0.9532ANCOVA
Comparison: Day 7: All Post-CAC Time Pointsp-value: 0.7522ANCOVA
Comparison: Day 8: Pre-CACp-value: 0.6804ANCOVA
Comparison: Day 8: 10 Minutes Post-CACp-value: 0.6267ANCOVA
Comparison: Day 8: 15 Minutes Post-CACp-value: 0.0976ANCOVA
Comparison: Day 8: 20 Minutes Post-CACp-value: 0.4687ANCOVA
Comparison: Day 8: 25 Minutes Post-CACp-value: 0.0421ANCOVA
Comparison: Day 8: 30 Minutes Post-CACp-value: 0.6085ANCOVA
Comparison: Day 8: All Post-CAC Time Pointsp-value: 0.9634ANCOVA
Secondary
Eyelid Swelling
Eyelid swelling evaluated by the subject. Eyelid swelling was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less swelling.
Time frame: Day 7 and 8
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 | Eyelid Swelling | Day 7, Pre-Conjunctival Allergen Challenge | 0.45 score on a scale | Standard Deviation 0.711 |
| Group 1 | Eyelid Swelling | Day 7, 10 Minutes Post Conjunctival Allergen Challenge | 1.22 score on a scale | Standard Deviation 0.889 |
| Group 1 | Eyelid Swelling | Day 7, 15 Minutes Post Conjunctival Allergen Challenge | 1.25 score on a scale | Standard Deviation 0.915 |
| Group 1 | Eyelid Swelling | Day 7, 20 Minutes Post Conjunctival Allergen Challenge | 1.06 score on a scale | Standard Deviation 0.776 |
| Group 1 | Eyelid Swelling | Day 7, 25 Minutes Post Conjunctival Allergen Challenge | 0.96 score on a scale | Standard Deviation 0.711 |
| Group 1 | Eyelid Swelling | Day 7, 30 Minutes Post Conjunctival Allergen Challenge | 0.79 score on a scale | Standard Deviation 0.78 |
| Group 1 | Eyelid Swelling | Day 8, pre-Conjunctival Allergen Challenge | 0.41 score on a scale | Standard Deviation 0.621 |
| Group 1 | Eyelid Swelling | Day 8, 10 Minutes Post Conjunctival Allergen Challenge | 1.35 score on a scale | Standard Deviation 0.744 |
| Group 1 | Eyelid Swelling | Day 8, 15 Minutes Post Conjunctival Allergen Challenge | 1.29 score on a scale | Standard Deviation 0.74 |
| Group 1 | Eyelid Swelling | Day 8, 20 Minutes Post Conjunctival Allergen Challenge | 1.12 score on a scale | Standard Deviation 0.817 |
| Group 1 | Eyelid Swelling | Day 8, 25 Minutes Post Conjunctival Allergen Challenge | 0.94 score on a scale | Standard Deviation 0.766 |
| Group 1 | Eyelid Swelling | Day 8, 30 Minutes Post Conjunctival Allergen Challenge | 0.81 score on a scale | Standard Deviation 0.728 |
| Group 2 | Eyelid Swelling | Day 8, 25 Minutes Post Conjunctival Allergen Challenge | 1.10 score on a scale | Standard Deviation 0.893 |
| Group 2 | Eyelid Swelling | Day 7, Pre-Conjunctival Allergen Challenge | 0.22 score on a scale | Standard Deviation 0.404 |
| Group 2 | Eyelid Swelling | Day 8, pre-Conjunctival Allergen Challenge | 0.26 score on a scale | Standard Deviation 0.5 |
| Group 2 | Eyelid Swelling | Day 7, 10 Minutes Post Conjunctival Allergen Challenge | 1.39 score on a scale | Standard Deviation 0.871 |
| Group 2 | Eyelid Swelling | Day 8, 20 Minutes Post Conjunctival Allergen Challenge | 1.11 score on a scale | Standard Deviation 0.887 |
| Group 2 | Eyelid Swelling | Day 7, 15 Minutes Post Conjunctival Allergen Challenge | 1.33 score on a scale | Standard Deviation 0.837 |
| Group 2 | Eyelid Swelling | Day 8, 10 Minutes Post Conjunctival Allergen Challenge | 1.21 score on a scale | Standard Deviation 0.873 |
| Group 2 | Eyelid Swelling | Day 7, 20 Minutes Post Conjunctival Allergen Challenge | 1.25 score on a scale | Standard Deviation 0.841 |
| Group 2 | Eyelid Swelling | Day 8, 30 Minutes Post Conjunctival Allergen Challenge | 0.89 score on a scale | Standard Deviation 0.887 |
| Group 2 | Eyelid Swelling | Day 7, 25 Minutes Post Conjunctival Allergen Challenge | 1.22 score on a scale | Standard Deviation 0.857 |
| Group 2 | Eyelid Swelling | Day 8, 15 Minutes Post Conjunctival Allergen Challenge | 1.19 score on a scale | Standard Deviation 0.881 |
| Group 2 | Eyelid Swelling | Day 7, 30 Minutes Post Conjunctival Allergen Challenge | 0.97 score on a scale | Standard Deviation 0.836 |
Comparison: Day 7: Pre-CACp-value: 0.0603ANCOVA
Comparison: Day 7: 10 minutes Post-CACp-value: 0.4857ANCOVA
Comparison: Day 7: 15 Minutes Post-CACp-value: 0.9815ANCOVA
Comparison: Day 7: 20 Minutes Post-CACp-value: 0.6213ANCOVA
Comparison: Day 7: 25 Minutes Post-CACp-value: 0.1831ANCOVA
Comparison: Day 7: 30 Minutes Post-CACp-value: 0.6489ANCOVA
Comparison: Day 7: All Post-CAC Time Pointsp-value: 0.2622ANCOVA
Comparison: Day 8: Pre-CACp-value: 0.2397ANCOVA
Comparison: Day 8: 10 Minutes Post-CACp-value: 0.3202ANCOVA
Comparison: Day 8: 15 Minutes Post-CACp-value: 0.2663ANCOVA
Comparison: Day 8: 20 Minutes Post-CACp-value: 0.5672ANCOVA
Comparison: Day 8: 25 Minutes Post-CACp-value: 0.5055ANCOVA
Comparison: Day 8: 30 Minutes Post-CACp-value: 0.8143ANCOVA
Comparison: Day 8: All Post-CAC Time Pointsp-value: 0.6901ANCOVA
Secondary
Nasal Composite Score
A composite score of presence or absence of at least one nasal symptom evaluated by the subject
Time frame: Day 7 and 8
Population: Pre-Conjunctival Allergen Challenge not evaluated in subject 1-011 on visit 5B
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1 | Nasal Composite Score | Day 8, 30 Minutes Post Conjunctival Allergen Challenge | PResent | 31 Participants |
| Group 1 | Nasal Composite Score | Day 8, 20 Minutes Post Conjunctival Allergen Challenge | Absent | 4 Participants |
| Group 1 | Nasal Composite Score | Day 8, 20 Minutes Post Conjunctival Allergen Challenge | PResent | 30 Participants |
| Group 1 | Nasal Composite Score | Day 8, 25 Minutes Post Conjunctival Allergen Challenge | Absent | 2 Participants |
| Group 1 | Nasal Composite Score | Day 8, 25 Minutes Post Conjunctival Allergen Challenge | PResent | 32 Participants |
| Group 1 | Nasal Composite Score | Day 8, 30 Minutes Post Conjunctival Allergen Challenge | Absent | 3 Participants |
| Group 1 | Nasal Composite Score | Day 8, 15 Minutes Post Conjunctival Allergen Challenge | PResent | 32 Participants |
| Group 1 | Nasal Composite Score | Day 7, Pre-Conjunctival Allergen Challenge | Absent | 11 Participants |
| Group 1 | Nasal Composite Score | Day 7, Pre-Conjunctival Allergen Challenge | PResent | 22 Participants |
| Group 1 | Nasal Composite Score | Day 7, 10 Minutes Post Conjunctival Allergen Challenge | Absent | 2 Participants |
| Group 1 | Nasal Composite Score | Day 7, 10 Minutes Post Conjunctival Allergen Challenge | PResent | 32 Participants |
| Group 1 | Nasal Composite Score | Day 7, 15 Minutes Post Conjunctival Allergen Challenge | Absent | 2 Participants |
| Group 1 | Nasal Composite Score | Day 7, 15 Minutes Post Conjunctival Allergen Challenge | PResent | 32 Participants |
| Group 1 | Nasal Composite Score | Day 7, 20 Minutes Post Conjunctival Allergen Challenge | Absent | 3 Participants |
| Group 1 | Nasal Composite Score | Day 7, 20 Minutes Post Conjunctival Allergen Challenge | PResent | 31 Participants |
| Group 1 | Nasal Composite Score | Day 7, 25 Minutes Post Conjunctival Allergen Challenge | Absent | 5 Participants |
| Group 1 | Nasal Composite Score | Day 7, 25 Minutes Post Conjunctival Allergen Challenge | PResent | 29 Participants |
| Group 1 | Nasal Composite Score | Day 7, 30 Minutes Post Conjunctival Allergen Challenge | Absent | 4 Participants |
| Group 1 | Nasal Composite Score | Day 7, 30 Minutes Post Conjunctival Allergen Challenge | PResent | 30 Participants |
| Group 1 | Nasal Composite Score | Day 8, pre-Conjunctival Allergen Challenge | Absent | 18 Participants |
| Group 1 | Nasal Composite Score | Day 8, pre-Conjunctival Allergen Challenge | PResent | 16 Participants |
| Group 1 | Nasal Composite Score | Day 8, 10 Minutes Post Conjunctival Allergen Challenge | Absent | 1 Participants |
| Group 1 | Nasal Composite Score | Day 8, 10 Minutes Post Conjunctival Allergen Challenge | PResent | 33 Participants |
| Group 1 | Nasal Composite Score | Day 8, 15 Minutes Post Conjunctival Allergen Challenge | Absent | 2 Participants |
| Group 2 | Nasal Composite Score | Day 8, 10 Minutes Post Conjunctival Allergen Challenge | PResent | 34 Participants |
| Group 2 | Nasal Composite Score | Day 8, 15 Minutes Post Conjunctival Allergen Challenge | PResent | 33 Participants |
| Group 2 | Nasal Composite Score | Day 7, 15 Minutes Post Conjunctival Allergen Challenge | PResent | 34 Participants |
| Group 2 | Nasal Composite Score | Day 8, 20 Minutes Post Conjunctival Allergen Challenge | Absent | 4 Participants |
| Group 2 | Nasal Composite Score | Day 7, 30 Minutes Post Conjunctival Allergen Challenge | PResent | 32 Participants |
| Group 2 | Nasal Composite Score | Day 8, 20 Minutes Post Conjunctival Allergen Challenge | PResent | 32 Participants |
| Group 2 | Nasal Composite Score | Day 7, 20 Minutes Post Conjunctival Allergen Challenge | Absent | 3 Participants |
| Group 2 | Nasal Composite Score | Day 8, 25 Minutes Post Conjunctival Allergen Challenge | Absent | 5 Participants |
| Group 2 | Nasal Composite Score | Day 8, 10 Minutes Post Conjunctival Allergen Challenge | Absent | 2 Participants |
| Group 2 | Nasal Composite Score | Day 8, 25 Minutes Post Conjunctival Allergen Challenge | PResent | 31 Participants |
| Group 2 | Nasal Composite Score | Day 7, 20 Minutes Post Conjunctival Allergen Challenge | PResent | 33 Participants |
| Group 2 | Nasal Composite Score | Day 8, 30 Minutes Post Conjunctival Allergen Challenge | Absent | 6 Participants |
| Group 2 | Nasal Composite Score | Day 8, pre-Conjunctival Allergen Challenge | Absent | 26 Participants |
| Group 2 | Nasal Composite Score | Day 8, 30 Minutes Post Conjunctival Allergen Challenge | PResent | 30 Participants |
| Group 2 | Nasal Composite Score | Day 7, 25 Minutes Post Conjunctival Allergen Challenge | Absent | 4 Participants |
| Group 2 | Nasal Composite Score | Day 7, Pre-Conjunctival Allergen Challenge | Absent | 23 Participants |
| Group 2 | Nasal Composite Score | Day 8, 15 Minutes Post Conjunctival Allergen Challenge | Absent | 3 Participants |
| Group 2 | Nasal Composite Score | Day 7, Pre-Conjunctival Allergen Challenge | PResent | 13 Participants |
| Group 2 | Nasal Composite Score | Day 7, 25 Minutes Post Conjunctival Allergen Challenge | PResent | 32 Participants |
| Group 2 | Nasal Composite Score | Day 7, 10 Minutes Post Conjunctival Allergen Challenge | Absent | 2 Participants |
| Group 2 | Nasal Composite Score | Day 8, pre-Conjunctival Allergen Challenge | PResent | 10 Participants |
| Group 2 | Nasal Composite Score | Day 7, 10 Minutes Post Conjunctival Allergen Challenge | PResent | 34 Participants |
| Group 2 | Nasal Composite Score | Day 7, 30 Minutes Post Conjunctival Allergen Challenge | Absent | 4 Participants |
| Group 2 | Nasal Composite Score | Day 7, 15 Minutes Post Conjunctival Allergen Challenge | Absent | 2 Participants |
Comparison: Day 7: 10 minutes post-CACp-value: >0.9999Fisher Exact
Comparison: Day 7: 15 minutes post-CACp-value: >0.9999Fisher Exact
Comparison: Day 7: 20 minutes post-CACp-value: >0.9999Fisher Exact
Comparison: Day 7: 25 minutes post-CACp-value: 0.7312Fisher Exact
Comparison: Day 7: 30 minutes post-CACp-value: >0.9999Fisher Exact
Comparison: Day 8: 10 minutes post-CACp-value: >0.9999Fisher Exact
Comparison: Day 8: 15 minutes post-CACp-value: >0.9999Fisher Exact
Comparison: Day 8: 20 minutes post-CACp-value: >0.9999Fisher Exact
Comparison: Day 8: 25 minutes post-CACp-value: 0.4297Fisher Exact
Comparison: Day 8: 30 minutes post-CACp-value: 0.4791Fisher Exact
Secondary
Nasal Congestion
Nasal congestion evaluated by the subject. Nasal congestion was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less severity.
Time frame: Day 7 and 8
Population: Pre-Conjunctival Allergen Challenge not evaluated in subject 1-011 on visit 5B
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 | Nasal Congestion | Day 7, Pre-Conjunctival Allergen Challenge | 0.67 score on a scale | Standard Deviation 0.816 |
| Group 1 | Nasal Congestion | Day 7, 10 Minutes Post Conjunctival Allergen Challenge | 1.44 score on a scale | Standard Deviation 1.16 |
| Group 1 | Nasal Congestion | Day 7, 15 Minutes Post Conjunctival Allergen Challenge | 1.41 score on a scale | Standard Deviation 1.048 |
| Group 1 | Nasal Congestion | Day 7, 20 Minutes Post Conjunctival Allergen Challenge | 1.24 score on a scale | Standard Deviation 0.987 |
| Group 1 | Nasal Congestion | Day 7, 25 Minutes Post Conjunctival Allergen Challenge | 1.15 score on a scale | Standard Deviation 0.989 |
| Group 1 | Nasal Congestion | Day 7, 30 Minutes Post Conjunctival Allergen Challenge | 1.12 score on a scale | Standard Deviation 1.008 |
| Group 1 | Nasal Congestion | Day 8, pre-Conjunctival Allergen Challenge | 0.47 score on a scale | Standard Deviation 0.662 |
| Group 1 | Nasal Congestion | Day 8, 10 Minutes Post Conjunctival Allergen Challenge | 1.29 score on a scale | Standard Deviation 1.06 |
| Group 1 | Nasal Congestion | Day 8, 15 Minutes Post Conjunctival Allergen Challenge | 1.35 score on a scale | Standard Deviation 1.07 |
| Group 1 | Nasal Congestion | Day 8, 20 Minutes Post Conjunctival Allergen Challenge | 1.26 score on a scale | Standard Deviation 1.024 |
| Group 1 | Nasal Congestion | Day 8, 25 Minutes Post Conjunctival Allergen Challenge | 1.18 score on a scale | Standard Deviation 0.968 |
| Group 1 | Nasal Congestion | Day 8, 30 Minutes Post Conjunctival Allergen Challenge | 1.15 score on a scale | Standard Deviation 1.048 |
| Group 2 | Nasal Congestion | Day 8, 25 Minutes Post Conjunctival Allergen Challenge | 1.28 score on a scale | Standard Deviation 1.21 |
| Group 2 | Nasal Congestion | Day 7, Pre-Conjunctival Allergen Challenge | 0.42 score on a scale | Standard Deviation 0.906 |
| Group 2 | Nasal Congestion | Day 8, pre-Conjunctival Allergen Challenge | 0.33 score on a scale | Standard Deviation 0.717 |
| Group 2 | Nasal Congestion | Day 7, 10 Minutes Post Conjunctival Allergen Challenge | 1.47 score on a scale | Standard Deviation 1.23 |
| Group 2 | Nasal Congestion | Day 8, 20 Minutes Post Conjunctival Allergen Challenge | 1.28 score on a scale | Standard Deviation 1.279 |
| Group 2 | Nasal Congestion | Day 7, 15 Minutes Post Conjunctival Allergen Challenge | 1.36 score on a scale | Standard Deviation 1.099 |
| Group 2 | Nasal Congestion | Day 8, 10 Minutes Post Conjunctival Allergen Challenge | 1.36 score on a scale | Standard Deviation 1.199 |
| Group 2 | Nasal Congestion | Day 7, 20 Minutes Post Conjunctival Allergen Challenge | 1.22 score on a scale | Standard Deviation 1.072 |
| Group 2 | Nasal Congestion | Day 8, 30 Minutes Post Conjunctival Allergen Challenge | 1.22 score on a scale | Standard Deviation 1.222 |
| Group 2 | Nasal Congestion | Day 7, 25 Minutes Post Conjunctival Allergen Challenge | 1.22 score on a scale | Standard Deviation 1.174 |
| Group 2 | Nasal Congestion | Day 8, 15 Minutes Post Conjunctival Allergen Challenge | 1.39 score on a scale | Standard Deviation 1.293 |
| Group 2 | Nasal Congestion | Day 7, 30 Minutes Post Conjunctival Allergen Challenge | 1.17 score on a scale | Standard Deviation 1.159 |
Comparison: Day 7: Pre-CACp-value: 0.8818ANCOVA
Comparison: Day 7: 10 minutes Post-CACp-value: 0.8679ANCOVA
Comparison: Day 7: 15 Minutes Post-CACp-value: 0.7856ANCOVA
Comparison: Day 7: 20 Minutes Post-CACp-value: 0.7507ANCOVA
Comparison: Day 7: 25 Minutes Post-CACp-value: 0.8189ANCOVA
Comparison: Day 7: 30 Minutes Post-CACp-value: 0.9206ANCOVA
Comparison: Day 7: All Post-CAC Time Pointsp-value: 0.9591ANCOVA
Comparison: Day 8: Pre-CACp-value: 0.5302ANCOVA
Comparison: Day 8: 10 Minutes Post-CACp-value: 0.7591ANCOVA
Comparison: Day 8: 15 Minutes Post-CACp-value: 0.8978ANCOVA
Comparison: Day 8: 20 Minutes Post-CACp-value: 0.7179ANCOVA
Comparison: Day 8: 25 Minutes Post-CACp-value: 0.7262ANCOVA
Comparison: Day 8: 30 Minutes Post-CACp-value: 0.8275ANCOVA
Comparison: Day 8: All Post-CAC Time Pointsp-value: 0.618ANCOVA
Secondary
Nasal Pruritus
Nasal Pruritus evaluated by the subject. Nasal pruritus was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less severity.
Time frame: Day 7 and 8
Population: Pre-Conjunctival Allergen Challenge not evaluated in subject 1-011 on visit 5B
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 | Nasal Pruritus | Day 7, Pre-Conjunctival Allergen Challenge | 0.30 score on a scale | Standard Deviation 0.467 |
| Group 1 | Nasal Pruritus | Day 7, 10 Minutes Post Conjunctival Allergen Challenge | 1.03 score on a scale | Standard Deviation 1.141 |
| Group 1 | Nasal Pruritus | Day 7, 15 Minutes Post Conjunctival Allergen Challenge | 0.91 score on a scale | Standard Deviation 0.965 |
| Group 1 | Nasal Pruritus | Day 7, 20 Minutes Post Conjunctival Allergen Challenge | 0.76 score on a scale | Standard Deviation 0.923 |
| Group 1 | Nasal Pruritus | Day 7, 25 Minutes Post Conjunctival Allergen Challenge | 0.76 score on a scale | Standard Deviation 0.89 |
| Group 1 | Nasal Pruritus | Day 7, 30 Minutes Post Conjunctival Allergen Challenge | 0.65 score on a scale | Standard Deviation 0.774 |
| Group 1 | Nasal Pruritus | Day 8, pre-Conjunctival Allergen Challenge | 0.24 score on a scale | Standard Deviation 0.554 |
| Group 1 | Nasal Pruritus | Day 8, 10 Minutes Post Conjunctival Allergen Challenge | 1.03 score on a scale | Standard Deviation 1.167 |
| Group 1 | Nasal Pruritus | Day 8, 15 Minutes Post Conjunctival Allergen Challenge | 1.03 score on a scale | Standard Deviation 1.087 |
| Group 1 | Nasal Pruritus | Day 8, 20 Minutes Post Conjunctival Allergen Challenge | 0.91 score on a scale | Standard Deviation 1.111 |
| Group 1 | Nasal Pruritus | Day 8, 25 Minutes Post Conjunctival Allergen Challenge | 0.68 score on a scale | Standard Deviation 0.912 |
| Group 1 | Nasal Pruritus | Day 8, 30 Minutes Post Conjunctival Allergen Challenge | 0.59 score on a scale | Standard Deviation 0.821 |
| Group 2 | Nasal Pruritus | Day 8, 25 Minutes Post Conjunctival Allergen Challenge | 0.69 score on a scale | Standard Deviation 1.009 |
| Group 2 | Nasal Pruritus | Day 7, Pre-Conjunctival Allergen Challenge | 0.06 score on a scale | Standard Deviation 0.232 |
| Group 2 | Nasal Pruritus | Day 8, pre-Conjunctival Allergen Challenge | 0.14 score on a scale | Standard Deviation 0.487 |
| Group 2 | Nasal Pruritus | Day 7, 10 Minutes Post Conjunctival Allergen Challenge | 1.11 score on a scale | Standard Deviation 1.116 |
| Group 2 | Nasal Pruritus | Day 8, 20 Minutes Post Conjunctival Allergen Challenge | 0.69 score on a scale | Standard Deviation 1.009 |
| Group 2 | Nasal Pruritus | Day 7, 15 Minutes Post Conjunctival Allergen Challenge | 1.03 score on a scale | Standard Deviation 1.082 |
| Group 2 | Nasal Pruritus | Day 8, 10 Minutes Post Conjunctival Allergen Challenge | 0.94 score on a scale | Standard Deviation 1.145 |
| Group 2 | Nasal Pruritus | Day 7, 20 Minutes Post Conjunctival Allergen Challenge | 0.89 score on a scale | Standard Deviation 0.95 |
| Group 2 | Nasal Pruritus | Day 8, 30 Minutes Post Conjunctival Allergen Challenge | 0.64 score on a scale | Standard Deviation 1.018 |
| Group 2 | Nasal Pruritus | Day 7, 25 Minutes Post Conjunctival Allergen Challenge | 0.83 score on a scale | Standard Deviation 0.971 |
| Group 2 | Nasal Pruritus | Day 8, 15 Minutes Post Conjunctival Allergen Challenge | 0.83 score on a scale | Standard Deviation 1.082 |
| Group 2 | Nasal Pruritus | Day 7, 30 Minutes Post Conjunctival Allergen Challenge | 0.75 score on a scale | Standard Deviation 0.967 |
Comparison: Day 7: Pre-CACp-value: 0.0111ANCOVA
Comparison: Day 7: 10 Minutes Post-CACp-value: 0.3391ANCOVA
Comparison: Day 7: 15 Minutes Post-CACp-value: 0.239ANCOVA
Comparison: Day 7: 20 Minutes Post-CACp-value: 0.3068ANCOVA
Comparison: Day 7: 25 Minutes Post-CACp-value: 0.4914ANCOVA
Comparison: Day 7: 30 Minutes Post-CACp-value: 0.5185ANCOVA
Comparison: Day 7: All Post-CAC Time Pointsp-value: 0.5262ANCOVA
Comparison: Day 8: Pre-CACp-value: 0.6098ANCOVA
Comparison: Day 8: 10 Minutes Post-CACp-value: 0.8849ANCOVA
Comparison: Day 8: 15 Minutes Post-CACp-value: 0.6941ANCOVA
Comparison: Day 8: 20 Minutes Post-CACp-value: 0.5728ANCOVA
Comparison: Day 8: 25 Minutes Post-CACp-value: 0.5931ANCOVA
Comparison: Day 8: 30 Minutes Post-CACp-value: 0.7513ANCOVA
Comparison: Day 8: All Post-CAC Time Pointsp-value: 0.7297ANCOVA
Secondary
Rhinorrhea
Rhinorrhea evaluated by the subject. Rhinorrhea was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less severity.
Time frame: Day 7 and 8
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 | Rhinorrhea | Day 7, Pre-Conjunctival Allergen Challenge | 0.33 score on a scale | Standard Deviation 0.595 |
| Group 1 | Rhinorrhea | Day 7, 10 Minutes Post Conjunctival Allergen Challenge | 1.35 score on a scale | Standard Deviation 1.152 |
| Group 1 | Rhinorrhea | Day 7, 15 Minutes Post Conjunctival Allergen Challenge | 1.18 score on a scale | Standard Deviation 0.904 |
| Group 1 | Rhinorrhea | Day 7, 20 Minutes Post Conjunctival Allergen Challenge | 0.97 score on a scale | Standard Deviation 0.87 |
| Group 1 | Rhinorrhea | Day 7, 25 Minutes Post Conjunctival Allergen Challenge | 0.85 score on a scale | Standard Deviation 0.821 |
| Group 1 | Rhinorrhea | Day 7, 30 Minutes Post Conjunctival Allergen Challenge | 0.85 score on a scale | Standard Deviation 0.784 |
| Group 1 | Rhinorrhea | Day 8, pre-Conjunctival Allergen Challenge | 0.29 score on a scale | Standard Deviation 0.579 |
| Group 1 | Rhinorrhea | Day 8, 10 Minutes Post Conjunctival Allergen Challenge | 1.29 score on a scale | Standard Deviation 0.938 |
| Group 1 | Rhinorrhea | Day 8, 15 Minutes Post Conjunctival Allergen Challenge | 1.26 score on a scale | Standard Deviation 0.963 |
| Group 1 | Rhinorrhea | Day 8, 20 Minutes Post Conjunctival Allergen Challenge | 1.09 score on a scale | Standard Deviation 0.933 |
| Group 1 | Rhinorrhea | Day 8, 25 Minutes Post Conjunctival Allergen Challenge | 1.00 score on a scale | Standard Deviation 0.853 |
| Group 1 | Rhinorrhea | Day 8, 30 Minutes Post Conjunctival Allergen Challenge | 0.94 score on a scale | Standard Deviation 0.776 |
| Group 2 | Rhinorrhea | Day 8, 25 Minutes Post Conjunctival Allergen Challenge | 0.92 score on a scale | Standard Deviation 1.18 |
| Group 2 | Rhinorrhea | Day 7, Pre-Conjunctival Allergen Challenge | 0.19 score on a scale | Standard Deviation 0.525 |
| Group 2 | Rhinorrhea | Day 8, pre-Conjunctival Allergen Challenge | 0.22 score on a scale | Standard Deviation 0.591 |
| Group 2 | Rhinorrhea | Day 7, 10 Minutes Post Conjunctival Allergen Challenge | 1.47 score on a scale | Standard Deviation 1.134 |
| Group 2 | Rhinorrhea | Day 8, 20 Minutes Post Conjunctival Allergen Challenge | 1.08 score on a scale | Standard Deviation 1.156 |
| Group 2 | Rhinorrhea | Day 7, 15 Minutes Post Conjunctival Allergen Challenge | 1.31 score on a scale | Standard Deviation 1.142 |
| Group 2 | Rhinorrhea | Day 8, 10 Minutes Post Conjunctival Allergen Challenge | 1.39 score on a scale | Standard Deviation 1.225 |
| Group 2 | Rhinorrhea | Day 7, 20 Minutes Post Conjunctival Allergen Challenge | 0.97 score on a scale | Standard Deviation 1.082 |
| Group 2 | Rhinorrhea | Day 8, 30 Minutes Post Conjunctival Allergen Challenge | 0.83 score on a scale | Standard Deviation 1.108 |
| Group 2 | Rhinorrhea | Day 7, 25 Minutes Post Conjunctival Allergen Challenge | 0.89 score on a scale | Standard Deviation 1.09 |
| Group 2 | Rhinorrhea | Day 8, 15 Minutes Post Conjunctival Allergen Challenge | 1.31 score on a scale | Standard Deviation 1.283 |
| Group 2 | Rhinorrhea | Day 7, 30 Minutes Post Conjunctival Allergen Challenge | 0.94 score on a scale | Standard Deviation 1.068 |
Comparison: Day 7: Pre-CACp-value: 0.66ANCOVA
Comparison: Day 7: 10 minutes Post-CACp-value: 0.6877ANCOVA
Comparison: Day 7: 15 Minutes Post-CACp-value: 0.334ANCOVA
Comparison: Day 7: 20 Minutes Post-CACp-value: 0.7874ANCOVA
Comparison: Day 7: 25 Minutes Post-CACp-value: 0.3812ANCOVA
Comparison: Day 7: 30 Minutes Post-CACp-value: 0.6987ANCOVA
Comparison: Day 7: All Post-CAC Time Pointsp-value: 0.6832ANCOVA
Comparison: Day 8: Pre-CACp-value: 0.8521ANCOVA
Comparison: Day 8: 10 Minutes Post-CACp-value: 0.7516ANCOVA
Comparison: Day 8: 15 Minutes Post-CACp-value: 0.6252ANCOVA
Comparison: Day 8: 20 Minutes Post-CACp-value: 0.8321ANCOVA
Comparison: Day 8: 25 Minutes Post-CACp-value: 0.8173ANCOVA
Comparison: Day 8: 30 Minutes Post-CACp-value: 0.5445ANCOVA
Comparison: Day 8: All Post-CAC Time Pointsp-value: 0.681ANCOVA
Secondary
Tearing/Watery Eyes
Tearing evaluated by the subject. Tearing was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less tearing.
Time frame: Day 7 and 8
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 | Tearing/Watery Eyes | Day 7, Pre-Conjunctival Allergen Challenge | 0.38 score on a scale | Standard Deviation 0.707 |
| Group 1 | Tearing/Watery Eyes | Day 7, 10 Minutes Post Conjunctival Allergen Challenge | 1.15 score on a scale | Standard Deviation 0.966 |
| Group 1 | Tearing/Watery Eyes | Day 7, 15 Minutes Post Conjunctival Allergen Challenge | 0.88 score on a scale | Standard Deviation 1.038 |
| Group 1 | Tearing/Watery Eyes | Day 7, 20 Minutes Post Conjunctival Allergen Challenge | 0.72 score on a scale | Standard Deviation 0.898 |
| Group 1 | Tearing/Watery Eyes | Day 7, 25 Minutes Post Conjunctival Allergen Challenge | 0.71 score on a scale | Standard Deviation 0.93 |
| Group 1 | Tearing/Watery Eyes | Day 7, 30 Minutes Post Conjunctival Allergen Challenge | 0.65 score on a scale | Standard Deviation 0.875 |
| Group 1 | Tearing/Watery Eyes | Day 8, pre-Conjunctival Allergen Challenge | 0.37 score on a scale | Standard Deviation 0.81 |
| Group 1 | Tearing/Watery Eyes | Day 8, 10 Minutes Post Conjunctival Allergen Challenge | 1.07 score on a scale | Standard Deviation 1.074 |
| Group 1 | Tearing/Watery Eyes | Day 8, 15 Minutes Post Conjunctival Allergen Challenge | 1.04 score on a scale | Standard Deviation 1.09 |
| Group 1 | Tearing/Watery Eyes | Day 8, 20 Minutes Post Conjunctival Allergen Challenge | 0.87 score on a scale | Standard Deviation 0.864 |
| Group 1 | Tearing/Watery Eyes | Day 8, 25 Minutes Post Conjunctival Allergen Challenge | 0.76 score on a scale | Standard Deviation 0.809 |
| Group 1 | Tearing/Watery Eyes | Day 8, 30 Minutes Post Conjunctival Allergen Challenge | 0.65 score on a scale | Standard Deviation 0.803 |
| Group 2 | Tearing/Watery Eyes | Day 8, 25 Minutes Post Conjunctival Allergen Challenge | 1.00 score on a scale | Standard Deviation 0.956 |
| Group 2 | Tearing/Watery Eyes | Day 7, Pre-Conjunctival Allergen Challenge | 0.21 score on a scale | Standard Deviation 0.437 |
| Group 2 | Tearing/Watery Eyes | Day 8, pre-Conjunctival Allergen Challenge | 0.28 score on a scale | Standard Deviation 0.553 |
| Group 2 | Tearing/Watery Eyes | Day 7, 10 Minutes Post Conjunctival Allergen Challenge | 1.38 score on a scale | Standard Deviation 1.024 |
| Group 2 | Tearing/Watery Eyes | Day 8, 20 Minutes Post Conjunctival Allergen Challenge | 1.01 score on a scale | Standard Deviation 0.906 |
| Group 2 | Tearing/Watery Eyes | Day 7, 15 Minutes Post Conjunctival Allergen Challenge | 1.22 score on a scale | Standard Deviation 1.003 |
| Group 2 | Tearing/Watery Eyes | Day 8, 10 Minutes Post Conjunctival Allergen Challenge | 1.15 score on a scale | Standard Deviation 0.97 |
| Group 2 | Tearing/Watery Eyes | Day 7, 20 Minutes Post Conjunctival Allergen Challenge | 1.07 score on a scale | Standard Deviation 0.965 |
| Group 2 | Tearing/Watery Eyes | Day 8, 30 Minutes Post Conjunctival Allergen Challenge | 0.88 score on a scale | Standard Deviation 0.952 |
| Group 2 | Tearing/Watery Eyes | Day 7, 25 Minutes Post Conjunctival Allergen Challenge | 0.94 score on a scale | Standard Deviation 1.034 |
| Group 2 | Tearing/Watery Eyes | Day 8, 15 Minutes Post Conjunctival Allergen Challenge | 1.13 score on a scale | Standard Deviation 0.929 |
| Group 2 | Tearing/Watery Eyes | Day 7, 30 Minutes Post Conjunctival Allergen Challenge | 0.85 score on a scale | Standard Deviation 0.909 |
Comparison: Day 7: Pre-CACp-value: 0.4032ANCOVA
Comparison: Day 7: 10 Minutes Post-CACp-value: 0.2946ANCOVA
Comparison: Day 7: 15 Minutes Post-CACp-value: 0.2863ANCOVA
Comparison: Day 7: 20 Minutes Post-CACp-value: 0.0891ANCOVA
Comparison: Day 7: 25 Minutes Post-CACp-value: 0.5347ANCOVA
Comparison: Day 7: 30 Minutes Post-CACp-value: 0.3733ANCOVA
Comparison: Day 7: All Post-CAC Time Pointsp-value: 0.2506ANCOVA
Comparison: Day 8: Pre-CACp-value: 0.8667ANCOVA
Comparison: Day 8: 10 Minutes Post-CACp-value: 0.764ANCOVA
Comparison: Day 8: 15 Minutes Post-CACp-value: 0.8008ANCOVA
Comparison: Day 8: 20 Minutes Post-CACp-value: 0.4729ANCOVA
Comparison: Day 8: 25 Minutes Post-CACp-value: 0.4742ANCOVA
Comparison: Day 8: 30 Minutes Post-CACp-value: 0.2922ANCOVA
Comparison: Day 8: All Post-CAC Time Pointsp-value: 0.3657ANCOVA