Trial Outcomes & Findings for A Study to Assess Safety and Efficacy in Participants Age 40 to 55 With Presbyopia (Old Eye) Who Receive AGN-190584 in Both Eyes Twice Daily (NCT NCT04983589)

Last Updated: 2023-03-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

230 participants

Primary outcome timeframe

3 hours after second dose on Day 14

Results posted on

2023-03-21

Participant Flow

Participants took part at 22 investigational sites in the United States from 02 September 2021 to 11 February 2022.

Participant milestones

Participant milestones
Measure	Vehicle Participants received vehicle, one drop bilaterally (in each eye), twice daily (BID), with a gap of 6 hours between both doses, for up to 14 days.	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.
Overall Study STARTED	116	114
Overall Study COMPLETED	113	111
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Vehicle Participants received vehicle, one drop bilaterally (in each eye), twice daily (BID), with a gap of 6 hours between both doses, for up to 14 days.	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.
Overall Study Withdrawal by Subject	0	3
Overall Study COVID-19 Infection	1	0
Overall Study COVID-19 Logistical Restrictions	2	0

Baseline Characteristics

A Study to Assess Safety and Efficacy in Participants Age 40 to 55 With Presbyopia (Old Eye) Who Receive AGN-190584 in Both Eyes Twice Daily

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vehicle n=116 Participants Participants received vehicle, one drop bilaterally (in each eye), BID, with a gap of 6 hours between both doses, for up to 14 days.	AGN-190584 n=114 Participants 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.	Total n=230 Participants Total of all reporting groups
Age, Continuous	50.3 years STANDARD_DEVIATION 3.87 • n=5 Participants	50.4 years STANDARD_DEVIATION 3.33 • n=7 Participants	50.3 years STANDARD_DEVIATION 3.60 • n=5 Participants
Sex: Female, Male Female	62 Participants n=5 Participants	70 Participants n=7 Participants	132 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants	44 Participants n=7 Participants	98 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	29 Participants n=5 Participants	30 Participants n=7 Participants	59 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	87 Participants n=5 Participants	84 Participants n=7 Participants	171 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants	17 Participants n=7 Participants	31 Participants n=5 Participants
Race (NIH/OMB) White	98 Participants n=5 Participants	93 Participants n=7 Participants	191 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vehicle n=116 Participants Participants received vehicle, one drop bilaterally (in each eye), BID, with a gap of 6 hours between both doses, for up to 14 days.	AGN-190584 n=114 Participants 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.
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	35.1 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Vehicle n=116 Participants Participants received vehicle, one drop bilaterally (in each eye), BID, with a gap of 6 hours between both doses, for up to 14 days.	AGN-190584 n=114 Participants 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.
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	32.5 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Vehicle n=116 Participants Participants received vehicle, one drop bilaterally (in each eye), BID, with a gap of 6 hours between both doses, for up to 14 days.	AGN-190584 n=114 Participants 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.
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	60.5 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Vehicle n=116 Participants Participants received vehicle, one drop bilaterally (in each eye), BID, with a gap of 6 hours between both doses, for up to 14 days.	AGN-190584 n=114 Participants 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.
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	44.7 percentage of participants

Adverse Events

Vehicle

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

AGN-190584

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Vehicle n=116 participants at risk Participants received vehicle, one drop bilaterally (in each eye), BID, with a gap of 6 hours between both doses, for up to 14 days.	AGN-190584 n=114 participants at risk 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.
Eye disorders EYE IRRITATION	0.00% 0/116 • SAEs and other AEs were collected from the time of study drug administration through study completion, an average of 15 days for each participant. Safety Population included all participants who received at least 1 administration of study treatment.	6.1% 7/114 • Number of events 16 • SAEs and other AEs were collected from the time of study drug administration through study completion, an average of 15 days for each participant. Safety Population included all participants who received at least 1 administration of study treatment.
Nervous system disorders HEADACHE	3.4% 4/116 • Number of events 4 • SAEs and other AEs were collected from the time of study drug administration through study completion, an average of 15 days for each participant. Safety Population included all participants who received at least 1 administration of study treatment.	8.8% 10/114 • Number of events 12 • SAEs and other AEs were collected from the time of study drug administration through study completion, an average of 15 days for each participant. Safety Population included all participants who received at least 1 administration of study treatment.

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Publication restrictions are in place

Restriction type: OTHER