Conjunctivitis, Allergic
Conditions
Brief summary
This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and efficacy of Relestat Ophthalmic Solution 0.05% in patients with allergic conjunctivitis who are treated with Relestat as standard of care in clinical practice.
Interventions
DRUGRelestat Ophthalmic Solution 0.05%
Relestat Ophthalmic Solution 0.05% prescribed as local standard of care in clinical practice.
Sponsors
Allergan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with Allergic Conjunctivitis treated with Relestat Ophthalmic Solution in clinical practice.
Exclusion criteria
* None.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Reporting Adverse Events | Up to 10 Months | An adverse event is any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. |
| Change From Baseline in Eye Symptoms Total Score on a 4-Point Scale | Baseline, 2 Weeks | Itchiness, conjunctival hyperaemia (redness), lacrimation (tearing), and foreign body sensation were each evaluated on a 4-point scale ranging from 0 (best) to 3 (worst). The eye symptom total score is the sum of the individual symptom scores and ranges from 0 (best) to 12 (worst). A negative number change from baseline indicates an improvement. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Relestat Ophthalmic Solution 0.05% Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice. | 745 |
| Total | 745 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 37 |
| Overall Study | Protocol Violation | 65 |
Baseline characteristics
| Characteristic | Relestat Ophthalmic Solution 0.05% |
|---|---|
| Age, Customized 20 to 29 years | 129 Participants |
| Age, Customized <20 years | 143 Participants |
| Age, Customized 30 to 39 years | 139 Participants |
| Age, Customized 40 to 49 years | 127 Participants |
| Age, Customized 50 to 59 years | 84 Participants |
| Age, Customized 60 to 69 years | 73 Participants |
| Age, Customized ≥70 years | 50 Participants |
| Sex: Female, Male Female | 487 Participants |
| Sex: Female, Male Male | 258 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 745 |
| serious Total, serious adverse events | 0 / 745 |
Outcome results
Primary
Change From Baseline in Eye Symptoms Total Score on a 4-Point Scale
Itchiness, conjunctival hyperaemia (redness), lacrimation (tearing), and foreign body sensation were each evaluated on a 4-point scale ranging from 0 (best) to 3 (worst). The eye symptom total score is the sum of the individual symptom scores and ranges from 0 (best) to 12 (worst). A negative number change from baseline indicates an improvement.
Time frame: Baseline, 2 Weeks
Population: Efficacy Assessment Population: included all patients in the Safety Assessment Population whose data was available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relestat Ophthalmic Solution 0.05% | Change From Baseline in Eye Symptoms Total Score on a 4-Point Scale | Baseline | 5.58 Scores on a Scale | Standard Deviation 2.25 |
| Relestat Ophthalmic Solution 0.05% | Change From Baseline in Eye Symptoms Total Score on a 4-Point Scale | Change from Baseline at 2 Weeks | -4.06 Scores on a Scale | Standard Deviation 2.17 |
Primary
Percentage of Patients Reporting Adverse Events
An adverse event is any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
Time frame: Up to 10 Months
Population: Safety Assessment Population: included all patients who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relestat Ophthalmic Solution 0.05% | Percentage of Patients Reporting Adverse Events | 0.13 Percentage of Patients |