Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study was to evaluate the ocular safety of an investigational ophthalmic solution in subjects 2 years of age and older with asymptomatic eyes when administered once daily in both eyes for up to 6 weeks.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AL-4943A | Experimental | AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks |
|
| AL-4943A Vehicle | Placebo Comparator | AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AL-4943A Ophthalmic Solution | Drug |
| ||
| AL-4943A Ophthalmic Solution Vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | An adverse event was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator. | An average of 6 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Terri Pasquine | Alcon Research | Study Director |
Not provided
Of the 518 enrolled subjects, 18 subjects were exited from the study as screen failures. This reporting group includes all randomized subjects.
Subjects were recruited from 15 study centers located in the United States.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | AL-4943A | AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks |
| FG001 | AL-4943A Vehicle | AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This reporting group includes all randomized subjects who received study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AL-4943A | AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks |
| BG001 | AL-4943A Vehicle | AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adverse Events | An adverse event was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator. | This reporting group includes all randomized subjects who received study medication. | Posted | Number | participants | An average of 6 weeks |
|
Adverse Events (AE) were collected for the duration of the study (3 months). An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship with the treatment.
This reporting group includes all randomized subjects who received study medication. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AL-4943A | AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Terri Pasquine, Sr. Clinical Project Lead | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Inactive ingredients used as placebo |
|
| Pregnancy |
|
| Randomized in error |
|
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 0 |
| 330 |
| 0 |
| 330 |
| EG001 | AL-4943A Vehicle | AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks | 0 | 169 | 0 | 169 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| D006967 |
| Hypersensitivity |
| D007154 | Immune System Diseases |