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A study to evaluate the safety and efficacy of AGN-199201 alone, AGN-190584 alone and concurrent use of AGN-199201 and AGN-190584 in patients with presbyopia (inability to focus for near vision).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AGN-199201 | Experimental | 1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each. |
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| AGN-190584 | Experimental | 1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each. |
|
| AGN-199201 + AGN-190584 in One Eye | Experimental | 1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each. |
|
| AGN-199201 + AGN-190584 in Both Eyes | Experimental | 1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGN-199201 | Drug | 1 to 2 drops of AGN-199201 ophthalmic solution in the eye(s) as per protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least a 2 Line Improvement From Baseline in Uncorrected Near Visual Acuity (UNVA) in the Non-Dominant Eye | UNVA is assessed without corrective lenses in the non-dominant eye. UNVA is measured using an eye chart and is reported as the number of lines read correctly. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of lines read correctly means that vision has improved. The percentages of patients with at least a 2 or more line improvement in UNVA in the non-dominant eye are presented. | Baseline, Day 3 |
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Inclusion Criteria:
-Presbyopia in each eye that impacts daily activities.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Newport Beach | California | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | AGN-199201 | 1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each. |
| FG001 | AGN-190584 | 1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each. |
| FG002 | AGN-199201 + AGN-190584 in One Eye | 1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each. |
| FG003 | AGN-199201 + AGN-190584 in Both Eyes | 1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | AGN-199201 | 1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each. |
| BG001 | AGN-190584 |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Percentage of Participants With at Least a 2 Line Improvement From Baseline in Uncorrected Near Visual Acuity (UNVA) in the Non-Dominant Eye | UNVA is assessed without corrective lenses in the non-dominant eye. UNVA is measured using an eye chart and is reported as the number of lines read correctly. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of lines read correctly means that vision has improved. The percentages of patients with at least a 2 or more line improvement in UNVA in the non-dominant eye are presented. | Modified Intent to Treat: all randomized patients with a baseline assessment and at least 1 postbaseline assessment of UNVA | Posted | Number | Percentage of Patients | Baseline, Day 3 |
|
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The Safety Population included all patients who received at least 1 dose of study treatment and was used to assess adverse events (AEs) and serious adverse events (SAEs).
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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 | AGN-199201 | 1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision Blurred | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| AGN-190584 | Drug | 1 to 2 drops of AGN-190584 ophthalmic solution in the eye(s) as per protocol. |
|
| AGN-199201 Vehicle | Drug | 1 to 2 drops of AGN-199201 vehicle in the eye(s) as per protocol. |
|
1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
| BG002 | AGN-199201 + AGN-190584 in One Eye | 1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each. |
| BG003 | AGN-199201 + AGN-190584 in Both Eyes | 1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | AGN-190584 | 1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each. |
| OG002 | AGN-199201 + AGN-190584 in One Eye | 1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each. |
| OG003 | AGN-199201 + AGN-190584 in Both Eyes | 1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each. |
|
|
| 0 |
| 15 |
| 5 |
| 15 |
| EG001 | AGN-190584 | 1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each. | 0 | 17 | 4 | 17 |
| EG002 | AGN-199201 + AGN-190584 in One Eye | 1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each. | 0 | 16 | 8 | 16 |
| EG003 | AGN-199201 + AGN-190584 in Both Eyes | 1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each. | 0 | 17 | 5 | 17 |
| Conjunctival Hyperaemia | Eye disorders | MedDRA version 17.1 | Systematic Assessment |
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| Lacrimation Increased | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Metamorphopsia | Eye disorders | MedDRA version 17.1 | Systematic Assessment |
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| Ocular Discomfort | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Eyelid Retraction | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Photophobia | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Eye Irritation | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Punctate Keratitis | Eye disorders | MedDRA version 17.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Product Taste Abnormal | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Discomfort | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
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| Blood Pressure Increased | Investigations | MedDRA version 17.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
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A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.