Allergic Conjunctivitis
Conditions
Keywords
Allergic conjunctivitis
Brief summary
The purpose of this study is to evaluate patient perceptions of olopatadine 0.2% dosed once daily in patients previously treated with twice-daily, topical, ocular, anti-allergy medications.
Interventions
DRUGOlopatadine hydrochloride ophthalmic solution, 0.2% (Pataday®)
Commercially marketed ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 12 years of age or older. * History (within the past 24 months) of allergic conjunctivitis. * Active signs and symptoms of ocular allergies. * Ocular health within normal limits, as determined by the investigator or subinvestigator. * Willing to avoid contact lens wear each study visit immediately prior to study medication instillation and for 10 minutes after instillation of study drug. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Contraindications or hypersensitivity to study medication or its components. * One sighted eye or not correctable to 0.6 logMAR or better in both eyes at the screening visit. * Known history of recurrent corneal erosion syndrome. * Ocular trauma or surgical intervention within 6 months prior to Visit 1. * Participation in any other investigational study within 30 days before Visit 1. * Pregnant or nursing. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Patient Satisfaction | Day 0 | Overall satisfaction was assessed by the patient on a questionnaire. The patient was instructed to select a single response to the statement, Overall, how satisfied are you with your current eye allergy medication? A 5-point scale was used: very satisfied, satisfied, undecided, dissatisfied, very dissatisfied. Results are reported as the percentage of patients who responded, very satisfied or satisfied. |
Participant flow
Recruitment details
Patients were recruited from 12 US study centers. Eligible patients having a history of allergic conjunctivitis and treated with protocol-specified anti-allergy medications for at least 7 days within 6 months prior to Visit 1 were enrolled. Investigators reviewed files to identify patients.
Pre-assignment details
215 patients were enrolled. All patients received the same treatment.
Participants by arm
| Arm | Count |
|---|---|
| Olopatadine 0.2% 1 drop self-administered in each eye once daily in the morning for 7 days | 215 |
| Total | 215 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Olopatadine 0.2% |
|---|---|
| Age, Categorical <=18 years | 7 Participants |
| Age, Categorical >=65 years | 81 Participants |
| Age, Categorical Between 18 and 65 years | 127 Participants |
| Age Continuous | 55.03 years STANDARD_DEVIATION 18.58 |
| Sex: Female, Male Female | 141 Participants |
| Sex: Female, Male Male | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 215 |
| serious Total, serious adverse events | 2 / 215 |
Outcome results
Primary
Overall Patient Satisfaction
Overall satisfaction was assessed by the patient on a questionnaire. The patient was instructed to select a single response to the statement, Overall, how satisfied are you with your current eye allergy medication? A 5-point scale was used: very satisfied, satisfied, undecided, dissatisfied, very dissatisfied. Results are reported as the percentage of patients who responded, very satisfied or satisfied.
Time frame: Day 0
Population: All subjects who used the study medication at least once (intent to treat).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Olopatadine 0.2% | Overall Patient Satisfaction | 70.1 Percentage of Participants |
Primary
Overall Patient Satisfaction
Overall satisfaction was assessed by the patient on a questionnaire. The patient was instructed to select a single response to the statement, Overall, how satisfied were you with olopatadine 0.2%? A 5-point scale was used: very satisfied, satisfied, undecided, dissatisfied, very dissatisfied. Results are reported as the percentage of patients who responded, very satisfied or satisfied.
Time frame: Day 7
Population: All subjects who used the study medication at least once (intent to treat).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Olopatadine 0.2% | Overall Patient Satisfaction | 89.3 Percentage of Participants |