Presbyopia
Conditions
Brief summary
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).
Interventions
DRUGAGN-199201
1 to 2 drops of AGN-199201 ophthalmic solution in the eye(s) as per protocol.
DRUGAGN-190584
1 to 2 drops of AGN-190584 ophthalmic solution in the eye(s) as per protocol.
1 to 2 drops of AGN-199201 vehicle in the eye(s) as per protocol.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
-Presbyopia in each eye that impacts daily activities.
Exclusion criteria
* Use of any topical ophthalmic medications, including artificial tears * Contact lens use in either eye within 14 days or planned use during the study * History of eye surgery * Diagnosis of any type of glaucoma or ocular hypertension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With at Least a 2 Line Improvement From Baseline in Uncorrected Near Visual Acuity (UNVA) in the Non-Dominant Eye | Baseline, Day 3 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| 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. | 17 |
| 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. | 16 |
| 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. | 17 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | AGN-199201 + AGN-190584 in One Eye | AGN-199201 + AGN-190584 in Both Eyes | Total | AGN-199201 | AGN-190584 |
|---|---|---|---|---|---|
| Age, Continuous | 48.7 Years STANDARD_DEVIATION 4.16 | 49.1 Years STANDARD_DEVIATION 3.97 | 49.2 Years STANDARD_DEVIATION 3.81 | 49.9 Years STANDARD_DEVIATION 3.88 | 49.1 Years STANDARD_DEVIATION 3.47 |
| Sex: Female, Male Female | 7 Participants | 10 Participants | 43 Participants | 13 Participants | 13 Participants |
| Sex: Female, Male Male | 9 Participants | 7 Participants | 22 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 15 | 4 / 17 | 8 / 16 | 5 / 17 |
| serious Total, serious adverse events | 0 / 15 | 0 / 17 | 0 / 16 | 0 / 17 |
Outcome results
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.
Time frame: Baseline, Day 3
Population: Modified Intent to Treat: all randomized patients with a baseline assessment and at least 1 postbaseline assessment of UNVA
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AGN-199201 | Percentage of Participants With at Least a 2 Line Improvement From Baseline in Uncorrected Near Visual Acuity (UNVA) in the Non-Dominant Eye | 46.7 Percentage of Patients |
| AGN-190584 | Percentage of Participants With at Least a 2 Line Improvement From Baseline in Uncorrected Near Visual Acuity (UNVA) in the Non-Dominant Eye | 70.6 Percentage of Patients |
| AGN-199201 + AGN-190584 in One Eye | Percentage of Participants With at Least a 2 Line Improvement From Baseline in Uncorrected Near Visual Acuity (UNVA) in the Non-Dominant Eye | 56.3 Percentage of Patients |
| AGN-199201 + AGN-190584 in Both Eyes | Percentage of Participants With at Least a 2 Line Improvement From Baseline in Uncorrected Near Visual Acuity (UNVA) in the Non-Dominant Eye | 68.8 Percentage of Patients |