Trial Outcomes & Findings for Safety and Efficacy of AGN-199201 and AGN-190584 in Patients With Presbyopia (NCT NCT02197806)

NCT ID: NCT02197806

Last Updated: 2015-12-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

65 participants

Primary outcome timeframe

Baseline, Day 3

Results posted on

2015-12-03

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.
Overall Study STARTED	15	17	16	17
Overall Study COMPLETED	15	16	16	16
Overall Study NOT COMPLETED	0	1	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.	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.
Overall Study Adverse Event	0	1	0	1

Baseline Characteristics

Safety and Efficacy of AGN-199201 and AGN-190584 in Patients With Presbyopia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AGN-199201 n=15 Participants 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.	AGN-190584 n=17 Participants 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 n=16 Participants 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 n=17 Participants 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.	Total n=65 Participants Total of all reporting groups
Age, Continuous	49.9 Years STANDARD_DEVIATION 3.88 • n=5 Participants	49.1 Years STANDARD_DEVIATION 3.47 • n=7 Participants	48.7 Years STANDARD_DEVIATION 4.16 • n=5 Participants	49.1 Years STANDARD_DEVIATION 3.97 • n=4 Participants	49.2 Years STANDARD_DEVIATION 3.81 • n=21 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	13 Participants n=7 Participants	7 Participants n=5 Participants	10 Participants n=4 Participants	43 Participants n=21 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants	7 Participants n=4 Participants	22 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline, Day 3

Population: Modified Intent to Treat: all randomized patients with a baseline assessment and at least 1 postbaseline assessment of UNVA

Outcome measures

Outcome measures
Measure	AGN-199201 n=15 Participants 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.	AGN-190584 n=17 Participants 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 n=16 Participants 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 n=16 Participants 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.
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	70.6 Percentage of Patients	56.3 Percentage of Patients	68.8 Percentage of Patients

Adverse Events

AGN-199201

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

AGN-190584

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

AGN-199201 + AGN-190584 in One Eye

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

AGN-199201 + AGN-190584 in Both Eyes

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Therapeutic Area Head,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	AGN-199201 n=15 participants at risk 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.	AGN-190584 n=17 participants at risk 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 n=16 participants at risk 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 n=17 participants at risk 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.
Eye disorders Vision Blurred	0.00% 0/15 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).	5.9% 1/17 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).	12.5% 2/16 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).	5.9% 1/17 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).
Eye disorders Conjunctival Hyperaemia	0.00% 0/15 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).	5.9% 1/17 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).	6.2% 1/16 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).	5.9% 1/17 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).
Eye disorders Lacrimation Increased	0.00% 0/15 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).	5.9% 1/17 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).	6.2% 1/16 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).	5.9% 1/17 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).
Eye disorders Metamorphopsia	0.00% 0/15 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).	0.00% 0/17 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).	0.00% 0/16 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).	5.9% 1/17 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).
Eye disorders Ocular Discomfort	0.00% 0/15 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).	0.00% 0/17 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).	12.5% 2/16 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).	0.00% 0/17 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).
Eye disorders Eyelid Retraction	26.7% 4/15 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).	0.00% 0/17 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).	6.2% 1/16 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).	0.00% 0/17 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).
Eye disorders Photophobia	0.00% 0/15 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).	0.00% 0/17 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).	6.2% 1/16 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).	0.00% 0/17 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).
Eye disorders Eye Irritation	0.00% 0/15 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).	5.9% 1/17 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).	0.00% 0/16 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).	0.00% 0/17 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).
Eye disorders Punctate Keratitis	6.7% 1/15 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).	0.00% 0/17 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).	0.00% 0/16 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).	0.00% 0/17 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).
Gastrointestinal disorders Nausea	0.00% 0/15 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).	0.00% 0/17 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).	0.00% 0/16 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).	5.9% 1/17 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).
General disorders Product Taste Abnormal	0.00% 0/15 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).	0.00% 0/17 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).	0.00% 0/16 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).	5.9% 1/17 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).
General disorders Discomfort	0.00% 0/15 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).	0.00% 0/17 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).	6.2% 1/16 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).	0.00% 0/17 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).
Infections and infestations Upper Respiratory Tract Infection	6.7% 1/15 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).	0.00% 0/17 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).	0.00% 0/16 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).	0.00% 0/17 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).
Investigations Blood Pressure Increased	0.00% 0/15 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).	5.9% 1/17 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).	0.00% 0/16 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).	0.00% 0/17 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).
Nervous system disorders Headache	0.00% 0/15 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).	0.00% 0/17 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).	12.5% 2/16 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).	17.6% 3/17 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).