Safety and Efficacy of AGN-199201 and AGN-190584 in Patients With Presbyopia
Overview
- Phase
- Phase 2
- Intervention
- AGN-199201
- Conditions
- Presbyopia
- Sponsor
- Allergan
- Enrollment
- 65
- Primary Endpoint
- Percentage of Participants With at Least a 2 Line Improvement From Baseline in Uncorrected Near Visual Acuity (UNVA) in the Non-Dominant Eye
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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).
Investigators
Eligibility Criteria
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
Arms & Interventions
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.
Intervention: AGN-199201
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.
Intervention: AGN-199201 Vehicle
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.
Intervention: AGN-190584
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.
Intervention: AGN-199201 Vehicle
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.
Intervention: AGN-199201
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.
Intervention: AGN-190584
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.
Intervention: AGN-199201 Vehicle
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.
Intervention: AGN-199201
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.
Intervention: AGN-190584
Outcomes
Primary Outcomes
Percentage of Participants With at Least a 2 Line Improvement From Baseline in Uncorrected Near Visual Acuity (UNVA) in the Non-Dominant Eye
Time Frame: 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.