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

Presbyopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02197806
• Other study ID #: 199201-007
• Status: Completed
• Phase: Phase 2
• First received: July 21, 2014
• Last updated: October 30, 2015
• Start date: July 2014
• Est. completion date: November 2014

Study information

• Verified date: October 2015
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: November 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Presbyopia

Intervention

Drug:
• AGN-199201
1 to 2 drops of AGN-199201 ophthalmic solution in the eye(s) as per protocol.
• AGN-190584
1 to 2 drops of AGN-190584 ophthalmic solution in the eye(s) as per protocol.
• AGN-199201 Vehicle
1 to 2 drops of AGN-199201 vehicle in the eye(s) as per protocol.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline, Day 3	No