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

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ClinicalTrials.gov Identifier: NCT02197806
Recruitment Status : Completed
First Posted : July 23, 2014
Results First Posted : December 3, 2015
Last Update Posted : December 3, 2015
Sponsor:
Information provided by (Responsible Party):
Allergan

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).

Condition or disease Intervention/treatment Phase
Presbyopia Drug: AGN-199201 Drug: AGN-190584 Drug: AGN-199201 Vehicle Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : July 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : November 2014

Arm Intervention/treatment
Experimental: 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.
Drug: AGN-199201
1 to 2 drops of AGN-199201 ophthalmic solution in the eye(s) as per protocol.

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

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

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

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

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

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

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

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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   40 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02197806


Locations
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United States, California
Newport Beach, California, United States
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02197806     History of Changes
Other Study ID Numbers: 199201-007
First Posted: July 23, 2014    Key Record Dates
Results First Posted: December 3, 2015
Last Update Posted: December 3, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions