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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Presbyopia
Interventions Drug: AGN-199201
Drug: AGN-190584
Drug: AGN-199201 Vehicle
Enrollment 65
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AGN-199201 AGN-190584 AGN-199201 + AGN-190584 in One Eye AGN-199201 + AGN-190584 in Both Eyes
Hide Arm/Group Description 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. 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. 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. 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.
Period Title: Overall Study
Started 15 17 16 17
Completed 15 16 16 16
Not Completed 0 1 0 1
Reason Not Completed
Adverse Event             0             1             0             1
Arm/Group Title AGN-199201 AGN-190584 AGN-199201 + AGN-190584 in One Eye AGN-199201 + AGN-190584 in Both Eyes Total
Hide Arm/Group Description 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. 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 15 17 16 17 65
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 17 participants 16 participants 17 participants 65 participants
49.9  (3.88) 49.1  (3.47) 48.7  (4.16) 49.1  (3.97) 49.2  (3.81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 17 participants 16 participants 17 participants 65 participants
Female
13
  86.7%
13
  76.5%
7
  43.8%
10
  58.8%
43
  66.2%
Male
2
  13.3%
4
  23.5%
9
  56.3%
7
  41.2%
22
  33.8%
1.Primary Outcome
Title Percentage of Participants With at Least a 2 Line Improvement From Baseline in Uncorrected Near Visual Acuity (UNVA) in the Non-Dominant Eye
Hide Description 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.
Time Frame Baseline, Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat: all randomized patients with a baseline assessment and at least 1 postbaseline assessment of UNVA
Arm/Group Title AGN-199201 AGN-190584 AGN-199201 + AGN-190584 in One Eye AGN-199201 + AGN-190584 in Both Eyes
Hide Arm/Group Description:
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.
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.
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.
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 Number of Participants Analyzed 15 17 16 16
Measure Type: Number
Unit of Measure: Percentage of Patients
46.7 70.6 56.3 68.8
Time Frame [Not Specified]
Adverse Event Reporting Description 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).
 
Arm/Group Title AGN-199201 AGN-190584 AGN-199201 + AGN-190584 in One Eye AGN-199201 + AGN-190584 in Both Eyes
Hide Arm/Group Description 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. 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. 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. 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.
All-Cause Mortality
AGN-199201 AGN-190584 AGN-199201 + AGN-190584 in One Eye AGN-199201 + AGN-190584 in Both Eyes
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
AGN-199201 AGN-190584 AGN-199201 + AGN-190584 in One Eye AGN-199201 + AGN-190584 in Both Eyes
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/17 (0.00%)   0/16 (0.00%)   0/17 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AGN-199201 AGN-190584 AGN-199201 + AGN-190584 in One Eye AGN-199201 + AGN-190584 in Both Eyes
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/15 (33.33%)   4/17 (23.53%)   8/16 (50.00%)   5/17 (29.41%) 
Eye disorders         
Vision Blurred * 1  0/15 (0.00%)  1/17 (5.88%)  2/16 (12.50%)  1/17 (5.88%) 
Conjunctival Hyperaemia  1  0/15 (0.00%)  1/17 (5.88%)  1/16 (6.25%)  1/17 (5.88%) 
Lacrimation Increased * 1  0/15 (0.00%)  1/17 (5.88%)  1/16 (6.25%)  1/17 (5.88%) 
Metamorphopsia  1  0/15 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
Ocular Discomfort * 1  0/15 (0.00%)  0/17 (0.00%)  2/16 (12.50%)  0/17 (0.00%) 
Eyelid Retraction * 1  4/15 (26.67%)  0/17 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Photophobia * 1  0/15 (0.00%)  0/17 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Eye Irritation * 1  0/15 (0.00%)  1/17 (5.88%)  0/16 (0.00%)  0/17 (0.00%) 
Punctate Keratitis  1  1/15 (6.67%)  0/17 (0.00%)  0/16 (0.00%)  0/17 (0.00%) 
Gastrointestinal disorders         
Nausea * 1  0/15 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
General disorders         
Product Taste Abnormal * 1  0/15 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
Discomfort * 1  0/15 (0.00%)  0/17 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Infections and infestations         
Upper Respiratory Tract Infection * 1  1/15 (6.67%)  0/17 (0.00%)  0/16 (0.00%)  0/17 (0.00%) 
Investigations         
Blood Pressure Increased  1  0/15 (0.00%)  1/17 (5.88%)  0/16 (0.00%)  0/17 (0.00%) 
Nervous system disorders         
Headache * 1  0/15 (0.00%)  0/17 (0.00%)  2/16 (12.50%)  3/17 (17.65%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 17.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head,
Organization: Allergan, Inc
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02197806    
Other Study ID Numbers: 199201-007
First Submitted: July 21, 2014
First Posted: July 23, 2014
Results First Submitted: October 30, 2015
Results First Posted: December 3, 2015
Last Update Posted: December 3, 2015