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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004317-27 | EudraCT Number |
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The purpose of this study is to evaluate olopatadine 0.2% QD (once per day) compared to olopatadine 0.1% BID (twice per day) in the treatment of ocular itching associated with allergic conjunctivitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PATADAY | Experimental | Olopatadine hydrochloride ophthalmic solution 0.2% in the morning and olopatadine 0.2% vehicle in the evening, 1 drop in each eye for 14 days |
|
| PATANOL | Active Comparator | Olopatadine hydrochloride ophthalmic solution 0.1%, 1 drop in each eye in the morning and evening, for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olopatadine Hydrochloride Ophthalmic Solution 0.2% | Drug |
|
| |
| Olopatadine Hydrochloride Ophthalmic Solution 0.1% |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Worst Ocular Itching Score During the 24 Hours Prior at Day 14 | Severity of ocular itching was evaluated as the worst score observed in the past 24 hours prior to each study visit. Ocular itching was assessed by the participant on a scale from 0-4, where 0=None and 4=Incapacitating itch. One eye (study eye) contributed to the analysis. | Baseline, Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Master, Clinical Medicine | Alcon (China) Ophthalmic Product Co., Ltd. | Study Director |
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Of the 383 enrolled, 130 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants (253).
Participants were recruited from 10 study centers located in China.
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| ID | Title | Description |
|---|---|---|
| FG000 | PATADAY | Olopatadine hydrochloride ophthalmic solution 0.2% in the morning and olopatadine 0.2% Vehicle in the evening, 1 drop in each eye for 14 days |
| FG001 | PATANOL | Olopatadine hydrochloride ophthalmic solution 0.1%, 1 drop in each eye in the morning and evening, for 14 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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This analysis population includes all participants who were randomized, received drug, had at least one on-therapy visit, satisfied inclusion/exclusion criteria, and had no major protocol deviations (Per Protocol Set).
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| ID | Title | Description |
|---|---|---|
| BG000 | PATADAY | Olopatadine hydrochloride ophthalmic solution 0.2% in the morning and olopatadine 0.2% Vehicle in the evening, 1 drop in each eye for 14 days |
| BG001 | PATANOL | Olopatadine hydrochloride ophthalmic solution 0.1%, 1 drop in each eye in the morning and evening, for 14 days |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change From Baseline in Worst Ocular Itching Score During the 24 Hours Prior at Day 14 | Severity of ocular itching was evaluated as the worst score observed in the past 24 hours prior to each study visit. Ocular itching was assessed by the participant on a scale from 0-4, where 0=None and 4=Incapacitating itch. One eye (study eye) contributed to the analysis. | Per Protocol Set with non-missing data | Posted | Mean | Standard Error | units on a scale | Baseline, Day 14 |
|
Adverse events (AEs) were collected from the time of informed consent and for the duration of participation in the study (2 weeks). This analysis group includes all participants who received study treatment. Ocular adverse events are presented for both study eye and non-study eye combined. AEs are reported as pre-treatment and treatment-emergent.
An AE is defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-treatment | All subjects who consented to participate in the study prior to the initiation of study treatment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Lead, GCRA-Pharma | Alcon, a Novartis Company | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
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| ID | Term |
|---|---|
| D000069605 | Olopatadine Hydrochloride |
| ID | Term |
|---|---|
| D003990 | Dibenzoxepins |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
|
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| Olopatadine 0.2% Vehicle | Drug | Inactive ingredients used as placebo comparator |
|
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Itching Score | Ocular itching was assessed by the participant on a scale from 0-4, where 0=None and 4=Incapacitating itch. | Mean | Standard Deviation | units on a scale |
|
Olopatadine hydrochloride ophthalmic solution 0.1%, 1 drop in each eye in the morning and evening, for 14 days
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|
| 0 |
| 383 |
| 0 |
| 383 |
| EG001 | PATADAY | All subjects treated with olopatadine hydrochloride ophthalmic solution 0.2% | 0 | 126 | 0 | 126 |
| EG002 | PATANOL | All subjects treated with olopatadine hydrochloride ophthalmic solution 0.1% | 0 | 126 | 0 | 126 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| D007154 |
| Immune System Diseases |