Presbyopia
Conditions
Keywords
Presbyopia, AGN-190584, Pilocarpine HCl 1.25%, Old Eye, Aged Eye
Brief summary
Currently available treatments for presbyopia (old eye) include nonsurgical options (spectacles or contact lenses) and surgical options, however, each has its own risks and limitations. The purpose of this study is to evaluate how effective AGN-190584 is in treating presbyopia compared to vehicle (placebo). AGN-190584 is an investigational drug being developed for the treatment of presbyopia. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to vehicle. Around 200 participants age 40-55 years with a diagnosis of presbyopia will be enrolled in the study in approximately 20 sites in the United States. Participants will receive AGN-190584 or vehicle in each eye twice daily for 14 days. There may be additional procedures for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a doctor's office. The effect of the treatment will be checked by medical assessments, vision/eye tests, checking for side effects and completing questionnaires.
Interventions
DRUGPilocarpine HCl
Pilocarpine HCl ophthalmic solution 1.25% ocular drops.
DRUGVehicle
Oxymetazoline HCl and pilocarpine HCl placebo ocular drops.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
\- Objective and subjective evidence of presbyopia.
Exclusion criteria
* Corneal abnormalities (including keratoconus, corneal scar, Fuchs' endothelial dystrophy, guttata, or edema) in either eye that are likely to interfere with visual acuity. * Narrow iridocorneal angles (Shaffer grade \<=2 or lower on gonioscopy examination), history of angle-closure glaucoma, or previous iridotomy. * Diagnosis of any type of glaucoma or ocular hypertension. * History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any intraocular surgery. * Use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Gaining 3 Lines or More in Mesopic, High-Contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) With No More Than 5-Letter Loss in Mesopic Corrected Distance Visual Acuity (CDVA) With the Same Refractive Correction | 3 hours after second dose on Day 14 | Visual acuity for near (40 centimeter \[cm\]) and distance (4 meter \[m\]) targets were measured in mesopic conditions using an eye chart. High contrast corrected distance visual acuity (CDVA) was assessed binocularly (in each eye) using the provided visual acuity charts for distance vision in a room with mesopic lighting conditions (10 to 11 lux) measured at the target. Both near vision and distance vision were measured to evaluate the effect of AGN-190584. A participant who gained 3 lines or more in mesopic, high contrast, binocular DCNVA with no more than 5-letter loss in mesopic CDVA with the same refractive correction was regarded as a responder. A participant with missing data was regarded as a non-responder. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Gaining 3 Lines or More in Photopic, High-Contrast, Binocular DCNVA With No More Than a 5-Letter Loss in Photopic CDVA With the Same Refractive Correction | 3 hours after second dose on Day 14 | Visual acuity for near (40 centimeter \[cm\]) and distance (4 meter \[m\]) targets were measured in photopic conditions using an eye chart. High contrast corrected distance visual acuity (CDVA) was assessed binocularly (in each eye) using the provided visual acuity charts for distance vision in a room with photopic lighting conditions (≥ 251 lux) measured at the target. Both near vision and distance vision were measured to evaluate the effect of AGN-190584. A participant who gained 3 lines or more in photopic, high contrast, binocular DCNVA with no more than 5-letter loss in photopic CDVA with the same refractive correction was regarded as a responder. A participant with missing data was regarded as a non-responder. |
| Percentage of Participants Gaining 2 Lines or More in Mesopic, High-Contrast, Binocular DCNVA With No More Than a 5-Letter Loss in Mesopic CDVA With the Same Refractive Correction | 3 hours after second dose on Day 14 | Visual acuity for near (40 centimeter \[cm\]) and distance (4 meter \[m\]) targets were measured in mesopic conditions using an eye chart. High contrast corrected distance visual acuity (CDVA) was assessed binocularly (in each eye) using the provided visual acuity charts for distance vision in a room with photopic lighting conditions (10 to 11 lux) measured at the target. Both near vision and distance vision were measured to evaluate the effect of AGN-190584. A participant who gained 2 lines or more in mesopic, high contrast, binocular DCNVA with no more than 5-letter loss in mesopic CDVA with the same refractive correction was regarded as a responder at that visit/timepoint. A participant with missing data was regarded as a non-responder. |
| Percentage of Participants Achieving 20/40 or Better in Mesopic, High-Contrast, Binocular DCNVA With No More Than a 5-Letter Loss in Mesopic CDVA With the Same Refractive Correction | 3 hours after second dose on Day 14 | Visual acuity for near (40 cm) target was measured in mesopic conditions using an eye chart. Both near vision and distance vision were measured to evaluate the effect of AGN-190584. A participant who achieved 20/40 or better in mesopic, high contrast, binocular DCNVA with no more than 5-letter loss in mesopic CDVA with the same refractive correction was regarded as a responder at that visit/timepoint. A participant with missing data was regarded as a non-responder. |
Countries
United States
Participant flow
Recruitment details
Participants took part at 22 investigational sites in the United States from 02 September 2021 to 11 February 2022.
Participants by arm
| Arm | Count |
|---|---|
| Vehicle Participants received vehicle, one drop bilaterally (in each eye), BID, with a gap of 6 hours between both doses, for up to 14 days. | 116 |
| AGN-190584 AGN-190584 ophthalmic solution, one drop bilaterally (in each eye), BID, with a gap of 6 hours between both doses, for up to 14 days. | 114 |
| Total | 230 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | COVID-19 Infection | 1 | 0 |
| Overall Study | COVID-19 Logistical Restrictions | 2 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 3 |
Baseline characteristics
| Characteristic | AGN-190584 | Total | Vehicle |
|---|---|---|---|
| Age, Continuous | 50.4 years STANDARD_DEVIATION 3.33 | 50.3 years STANDARD_DEVIATION 3.6 | 50.3 years STANDARD_DEVIATION 3.87 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 30 Participants | 59 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 84 Participants | 171 Participants | 87 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants | 31 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 93 Participants | 191 Participants | 98 Participants |
| Sex: Female, Male Female | 70 Participants | 132 Participants | 62 Participants |
| Sex: Female, Male Male | 44 Participants | 98 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 116 | 0 / 114 |
| other Total, other adverse events | 4 / 116 | 16 / 114 |
| serious Total, serious adverse events | 0 / 116 | 0 / 114 |
Outcome results
Primary
Percentage of Participants Gaining 3 Lines or More in Mesopic, High-Contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) With No More Than 5-Letter Loss in Mesopic Corrected Distance Visual Acuity (CDVA) With the Same Refractive Correction
Visual acuity for near (40 centimeter \[cm\]) and distance (4 meter \[m\]) targets were measured in mesopic conditions using an eye chart. High contrast corrected distance visual acuity (CDVA) was assessed binocularly (in each eye) using the provided visual acuity charts for distance vision in a room with mesopic lighting conditions (10 to 11 lux) measured at the target. Both near vision and distance vision were measured to evaluate the effect of AGN-190584. A participant who gained 3 lines or more in mesopic, high contrast, binocular DCNVA with no more than 5-letter loss in mesopic CDVA with the same refractive correction was regarded as a responder. A participant with missing data was regarded as a non-responder.
Time frame: 3 hours after second dose on Day 14
Population: ITT Population included all randomized participants. Percentages are rounded off to whole number at single decimal.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vehicle | Percentage of Participants Gaining 3 Lines or More in Mesopic, High-Contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) With No More Than 5-Letter Loss in Mesopic Corrected Distance Visual Acuity (CDVA) With the Same Refractive Correction | 7.8 percentage of participants |
| AGN-190584 | Percentage of Participants Gaining 3 Lines or More in Mesopic, High-Contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) With No More Than 5-Letter Loss in Mesopic Corrected Distance Visual Acuity (CDVA) With the Same Refractive Correction | 35.1 percentage of participants |
p-value: <0.000195% CI: [17.3, 37.4]Chi-squared
Secondary
Percentage of Participants Achieving 20/40 or Better in Mesopic, High-Contrast, Binocular DCNVA With No More Than a 5-Letter Loss in Mesopic CDVA With the Same Refractive Correction
Visual acuity for near (40 cm) target was measured in mesopic conditions using an eye chart. Both near vision and distance vision were measured to evaluate the effect of AGN-190584. A participant who achieved 20/40 or better in mesopic, high contrast, binocular DCNVA with no more than 5-letter loss in mesopic CDVA with the same refractive correction was regarded as a responder at that visit/timepoint. A participant with missing data was regarded as a non-responder.
Time frame: 3 hours after second dose on Day 14
Population: ITT Population included all randomized participants. Percentages are rounded off to whole number at single decimal.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vehicle | Percentage of Participants Achieving 20/40 or Better in Mesopic, High-Contrast, Binocular DCNVA With No More Than a 5-Letter Loss in Mesopic CDVA With the Same Refractive Correction | 24.1 percentage of participants |
| AGN-190584 | Percentage of Participants Achieving 20/40 or Better in Mesopic, High-Contrast, Binocular DCNVA With No More Than a 5-Letter Loss in Mesopic CDVA With the Same Refractive Correction | 44.7 percentage of participants |
p-value: 0.00195% CI: [8.6, 32.6]Chi-squared
Secondary
Percentage of Participants Gaining 2 Lines or More in Mesopic, High-Contrast, Binocular DCNVA With No More Than a 5-Letter Loss in Mesopic CDVA With the Same Refractive Correction
Visual acuity for near (40 centimeter \[cm\]) and distance (4 meter \[m\]) targets were measured in mesopic conditions using an eye chart. High contrast corrected distance visual acuity (CDVA) was assessed binocularly (in each eye) using the provided visual acuity charts for distance vision in a room with photopic lighting conditions (10 to 11 lux) measured at the target. Both near vision and distance vision were measured to evaluate the effect of AGN-190584. A participant who gained 2 lines or more in mesopic, high contrast, binocular DCNVA with no more than 5-letter loss in mesopic CDVA with the same refractive correction was regarded as a responder at that visit/timepoint. A participant with missing data was regarded as a non-responder.
Time frame: 3 hours after second dose on Day 14
Population: ITT Population included all randomized participants. Percentages are rounded off to whole number at single decimal.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vehicle | Percentage of Participants Gaining 2 Lines or More in Mesopic, High-Contrast, Binocular DCNVA With No More Than a 5-Letter Loss in Mesopic CDVA With the Same Refractive Correction | 25.9 percentage of participants |
| AGN-190584 | Percentage of Participants Gaining 2 Lines or More in Mesopic, High-Contrast, Binocular DCNVA With No More Than a 5-Letter Loss in Mesopic CDVA With the Same Refractive Correction | 60.5 percentage of participants |
p-value: <0.000195% CI: [22.7, 46.7]Chi-squared
Secondary
Percentage of Participants Gaining 3 Lines or More in Photopic, High-Contrast, Binocular DCNVA With No More Than a 5-Letter Loss in Photopic CDVA With the Same Refractive Correction
Visual acuity for near (40 centimeter \[cm\]) and distance (4 meter \[m\]) targets were measured in photopic conditions using an eye chart. High contrast corrected distance visual acuity (CDVA) was assessed binocularly (in each eye) using the provided visual acuity charts for distance vision in a room with photopic lighting conditions (≥ 251 lux) measured at the target. Both near vision and distance vision were measured to evaluate the effect of AGN-190584. A participant who gained 3 lines or more in photopic, high contrast, binocular DCNVA with no more than 5-letter loss in photopic CDVA with the same refractive correction was regarded as a responder. A participant with missing data was regarded as a non-responder.
Time frame: 3 hours after second dose on Day 14
Population: ITT Population included all randomized participants. Percentages are rounded off to whole number at single decimal.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vehicle | Percentage of Participants Gaining 3 Lines or More in Photopic, High-Contrast, Binocular DCNVA With No More Than a 5-Letter Loss in Photopic CDVA With the Same Refractive Correction | 6.0 percentage of participants |
| AGN-190584 | Percentage of Participants Gaining 3 Lines or More in Photopic, High-Contrast, Binocular DCNVA With No More Than a 5-Letter Loss in Photopic CDVA With the Same Refractive Correction | 32.5 percentage of participants |
p-value: <0.000195% CI: [16.8, 36]Chi-squared