A Study of the Concurrent Use of AGN-190584 and AGN-199201 in Participants With Presbyopia
Sponsor
Allergan (Industry)
Overall Status
Completed
CT.gov ID
NCT02595528
Collaborator
(none)
163
20
4
17.6
8.2
0.5
Study Details
Study Description
Brief Summary
This study will identify the optimum concentrations of AGN-199201 and AGN-190584 when dosed in combination once a day for the improvement of uncorrected near visual acuity in participants with presbyopia (inability to focus on items close-up).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
163 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Multicenter, Double-masked, Randomized, Vehicle-Controlled, Study of the Concurrent Use of AGN-190584 and AGN-199201 in Patients With Presbyopia
Actual Study Start Date
:
Apr 29, 2016
Actual Primary Completion Date
:
Oct 18, 2017
Actual Study Completion Date
:
Oct 18, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AGN-199201 and AGN-190584 Vehicle Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. |
Drug: AGN-199201 ophthalmic solution
1 drop of AGN-199201 ophthalmic solution Doses A, B, C in the eye.
Drug: AGN-190584 ophthalmic solution
1 drop AGN-190584 ophthalmic solution doses A, B and C in the eye.
Drug: AGN-190584 vehicle
Vehicle to AGN-190584
Drug: AGN-199201 + AGN-190584 Combination
1 drop AGN-199201 and AGN-190584 fixed combination ophthalmic solution in the eye.
Drug: AGN-199201 vehicle
Vehicle to AGN-199201
|
| Experimental: AGN-199201 and AGN-190584 Dose A Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. |
Drug: AGN-199201 ophthalmic solution
1 drop of AGN-199201 ophthalmic solution Doses A, B, C in the eye.
Drug: AGN-190584 ophthalmic solution
1 drop AGN-190584 ophthalmic solution doses A, B and C in the eye.
Drug: AGN-190584 vehicle
Vehicle to AGN-190584
Drug: AGN-199201 + AGN-190584 Combination
1 drop AGN-199201 and AGN-190584 fixed combination ophthalmic solution in the eye.
Drug: AGN-199201 vehicle
Vehicle to AGN-199201
|
| Experimental: AGN-199201 and AGN-190584 Dose B Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. |
Drug: AGN-199201 ophthalmic solution
1 drop of AGN-199201 ophthalmic solution Doses A, B, C in the eye.
Drug: AGN-190584 ophthalmic solution
1 drop AGN-190584 ophthalmic solution doses A, B and C in the eye.
Drug: AGN-190584 vehicle
Vehicle to AGN-190584
Drug: AGN-199201 + AGN-190584 Combination
1 drop AGN-199201 and AGN-190584 fixed combination ophthalmic solution in the eye.
Drug: AGN-199201 vehicle
Vehicle to AGN-199201
|
| Experimental: AGN-199201 and AGN-190584 Dose C Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. |
Drug: AGN-199201 ophthalmic solution
1 drop of AGN-199201 ophthalmic solution Doses A, B, C in the eye.
Drug: AGN-190584 ophthalmic solution
1 drop AGN-190584 ophthalmic solution doses A, B and C in the eye.
Drug: AGN-190584 vehicle
Vehicle to AGN-190584
Drug: AGN-199201 + AGN-190584 Combination
1 drop AGN-199201 and AGN-190584 fixed combination ophthalmic solution in the eye.
Drug: AGN-199201 vehicle
Vehicle to AGN-199201
|
Outcome Measures
Primary Outcome Measures
- Weighted Average Change From Baseline in Mesopic, High Contrast Uncorrected Near Visual Acuity (UNVA) Letters [Baseline, Between hour 1 and hour 10 of each of the five 2-day dosing periods]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
40 Years
to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-Normal vision at distance, either natural or post corneal laser refractive surgery, with presbyopia in each eye and complaints of poor near vision that impacts activities of daily living.
Exclusion Criteria:
-
Use of any topical ophthalmic medications, including artificial tears other than the study medications during the study
-
Corneal abnormalities in either eye that interfere with visual acuity
-
History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery or any intraocular surgery
-
Diagnosis of glaucoma or ocular hypertension.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sall Research Medical Center | Artesia | California | United States | 90701 |
| 2 | Milton M. Hom, OD, FAAO | Azusa | California | United States | 91702 |
| 3 | WCCT Global, LLC | Costa Mesa | California | United States | 92626 |
| 4 | The Eye Research Foundation | Newport Beach | California | United States | 92663 |
| 5 | North Bay Eye Associates, Inc. | Petaluma | California | United States | 94954 |
| 6 | Martel Eye Medical Group | Rancho Cordova | California | United States | 95670 |
| 7 | West Coast Eye Care | San Diego | California | United States | 92115 |
| 8 | Corneal Consultants of Colorado, P.C. | Littleton | Colorado | United States | 80120 |
| 9 | Mid Florida Eye Center | Mount Dora | Florida | United States | 32757 |
| 10 | Clayton Eye Center | Morrow | Georgia | United States | 30260 |
| 11 | Price Vision Group | Indianapolis | Indiana | United States | 46260 |
| 12 | Specialized Eye Care | Baltimore | Maryland | United States | 21210 |
| 13 | Comprehensive Eye Care, Ltd | Washington | Missouri | United States | 63090 |
| 14 | Cleveland Eye Clinic | Brecksville | Ohio | United States | 44141 |
| 15 | Scott & Christie and Associates, PC | Cranberry Township | Pennsylvania | United States | 16066 |
| 16 | Total Eye Care, PA | Memphis | Tennessee | United States | 38119 |
| 17 | Cataract and Glaucoma Center | El Paso | Texas | United States | 79902 |
| 18 | Medical Center Ophthalmology Associates | San Antonio | Texas | United States | 78240 |
| 19 | Hoopes Durrie Rivera Research, LLC | Draper | Utah | United States | 84020 |
| 20 | The Eye Centers of Racine & Kenosha | Kenosha | Wisconsin | United States | 53142 |
Sponsors and Collaborators
- Allergan
Investigators
- Study Director: Haixia Liu, Allergan
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Allergan
ClinicalTrials.gov Identifier:
NCT02595528
Other Study ID Numbers:
- 199201-009
First Posted:
Nov 3, 2015
Last Update Posted:
Dec 22, 2020
Last Verified:
Nov 1, 2020
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Randomization and treatment assignment were based on a randomization scheme prepared by Allergan Biostatistics prior to the start of the study. |
| Arm/Group Title | AGN-190584 Vehicle and AGN-199201 | AGN-190584 Lower Dose and AGN-199201 | AGN-190584 Medium Dose and AGN-199201 | AGN-190584 Higher Dose and AGN-199201 |
|---|---|---|---|---|
| Arm/Group Description | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. |
| Period Title: Overall Study | ||||
| STARTED | 41 | 40 | 42 | 40 |
| COMPLETED | 39 | 37 | 41 | 36 |
| NOT COMPLETED | 2 | 3 | 1 | 4 |
Baseline Characteristics
| Arm/Group Title | AGN-190584 Vehicle and AGN-199201 | AGN-190584 Lower Dose and AGN-199201 | AGN-190584 Medium Dose and AGN-199201 | AGN-190584 Higher Dose and AGN-199201 | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. | Total of all reporting groups |
| Overall Participants | 41 | 39 | 42 | 39 | 161 |
| Age (Years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [Years] |
46.6
(2.9)
|
47.1
(2.7)
|
46.8
(2.8)
|
46.7
(2.3)
|
46.8
(2.6)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
32
78%
|
27
69.2%
|
29
69%
|
24
61.5%
|
112
69.6%
|
| Male |
9
22%
|
12
30.8%
|
13
31%
|
15
38.5%
|
49
30.4%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||
| Hispanic or Latino |
7
17.1%
|
11
28.2%
|
3
7.1%
|
9
23.1%
|
30
18.6%
|
| Not Hispanic or Latino |
34
82.9%
|
28
71.8%
|
39
92.9%
|
30
76.9%
|
131
81.4%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
1
2.6%
|
1
2.4%
|
0
0%
|
2
1.2%
|
| Asian |
3
7.3%
|
1
2.6%
|
0
0%
|
0
0%
|
4
2.5%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
6
14.6%
|
6
15.4%
|
13
31%
|
3
7.7%
|
28
17.4%
|
| White |
32
78%
|
30
76.9%
|
28
66.7%
|
36
92.3%
|
126
78.3%
|
| More than one race |
0
0%
|
1
2.6%
|
0
0%
|
0
0%
|
1
0.6%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Baseline UNVA severity (Count of Participants) | |||||
| ≤ 20/80 |
26
63.4%
|
28
71.8%
|
28
66.7%
|
26
66.7%
|
108
67.1%
|
| > 20/80 |
15
36.6%
|
11
28.2%
|
14
33.3%
|
13
33.3%
|
53
32.9%
|
Outcome Measures
| Title | Weighted Average Change From Baseline in Mesopic, High Contrast Uncorrected Near Visual Acuity (UNVA) Letters |
|---|---|
| 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. |
| Time Frame | Baseline, Between hour 1 and hour 10 of each of the five 2-day dosing periods |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified Intent-to-Treat (mITT) population: all randomized patients who were randomized with a baseline and at least 1 post baseline assessment of mesopic, high contrast, UNVA. |
| Arm/Group Title | AGN-190584 Vehicle | AGN-190584 Lower Dose | AGN-190584 Medium Dose | AGN-190584 Higher Dose |
|---|---|---|---|---|
| Arm/Group Description | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. |
| Measure Participants | 40 | 37 | 42 | 38 |
| AGN-199201 Vehicle |
1.12
(0.48)
|
3.83
(0.37)
|
5.26
(0.37)
|
5.42
(0.50)
|
| AGN-199201 Lower Dose |
1.24
(0.44)
|
3.94
(0.34)
|
5.37
(0.34)
|
5.52
(0.46)
|
| AGN-199201 Medium Dose |
1.47
(0.47)
|
4.16
(0.39)
|
5.56
(0.39)
|
5.70
(0.48)
|
| AGN-199201 Higher Dose |
1.34
(0.55)
|
3.99
(0.41)
|
5.36
(0.40)
|
5.46
(0.56)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | AGN-190584 Vehicle, AGN-190584 Lower Dose, AGN-190584 Medium Dose, AGN-190584 Higher Dose |
|---|---|---|
| Comments | AGN-190584 Quadratic | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0029 |
| Comments | ||
| Method | Mixed model for repeated measures | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares (LS) |
| Estimated Value | -2.5543 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | AGN-190584 Vehicle, AGN-190584 Lower Dose, AGN-190584 Medium Dose, AGN-190584 Higher Dose |
|---|---|---|
| Comments | AGN-190584 Linear | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Mixed model for repeated measures | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares (LS) |
| Estimated Value | 6.6961 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | AGN-190584 Vehicle, AGN-190584 Lower Dose, AGN-190584 Medium Dose, AGN-190584 Higher Dose |
|---|---|---|
| Comments | AGN-199201 Quadratic | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4126 |
| Comments | ||
| Method | Mixed model for repeated measures | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares (LS) |
| Estimated Value | -69.890 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | AGN-190584 Vehicle, AGN-190584 Lower Dose, AGN-190584 Medium Dose, AGN-190584 Higher Dose |
|---|---|---|
| Comments | AGN-199201 Linear | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3752 |
| Comments | ||
| Method | Mixed model for repeated measures | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares (LS) |
| Estimated Value | 10.5017 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | Adverse events were collected for 112 days. | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Safety Population: all subjects who received ≥ 1 administration of study treatment. | |||||||
| Arm/Group Title | AGN-190584 Vehicle and AGN-199201 | AGN-190584 Lower Dose and AGN-199201 | AGN-190584 Medium Dose and AGN-199201 | AGN-190584 Higher Dose and AGN-199201 | ||||
| Arm/Group Description | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. | ||||
All Cause Mortality |
||||||||
| AGN-190584 Vehicle and AGN-199201 | AGN-190584 Lower Dose and AGN-199201 | AGN-190584 Medium Dose and AGN-199201 | AGN-190584 Higher Dose and AGN-199201 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/41 (0%) | 0/39 (0%) | 0/42 (0%) | 0/39 (0%) | ||||
Serious Adverse Events |
||||||||
| AGN-190584 Vehicle and AGN-199201 | AGN-190584 Lower Dose and AGN-199201 | AGN-190584 Medium Dose and AGN-199201 | AGN-190584 Higher Dose and AGN-199201 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/41 (2.4%) | 1/39 (2.6%) | 0/42 (0%) | 1/39 (2.6%) | ||||
| Hepatobiliary disorders | ||||||||
| Cholecystitis | 0/41 (0%) | 1/39 (2.6%) | 0/42 (0%) | 0/39 (0%) | ||||
| Investigations | ||||||||
| Cervix carcinoma stage 0 | 1/41 (2.4%) | 0/39 (0%) | 0/42 (0%) | 0/39 (0%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Malignant melanoma | 0/41 (0%) | 0/39 (0%) | 0/42 (0%) | 1/39 (2.6%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| AGN-190584 Vehicle and AGN-199201 | AGN-190584 Lower Dose and AGN-199201 | AGN-190584 Medium Dose and AGN-199201 | AGN-190584 Higher Dose and AGN-199201 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 9/41 (22%) | 9/39 (23.1%) | 16/42 (38.1%) | 17/39 (43.6%) | ||||
| Eye disorders | ||||||||
| Lacrimation increased | 0/41 (0%) | 3/39 (7.7%) | 2/42 (4.8%) | 0/39 (0%) | ||||
| Foreign body sensation in eyes | 1/41 (2.4%) | 2/39 (5.1%) | 0/42 (0%) | 0/39 (0%) | ||||
| Punctate keratitis | 2/41 (4.9%) | 1/39 (2.6%) | 4/42 (9.5%) | 2/39 (5.1%) | ||||
| Visual impairment | 1/41 (2.4%) | 0/39 (0%) | 1/42 (2.4%) | 4/39 (10.3%) | ||||
| Visual acuity reduced | 0/41 (0%) | 0/39 (0%) | 1/42 (2.4%) | 2/39 (5.1%) | ||||
| Vitreous floaters | 0/41 (0%) | 0/39 (0%) | 0/42 (0%) | 2/39 (5.1%) | ||||
| General disorders | ||||||||
| Instillation site pain | 3/41 (7.3%) | 0/39 (0%) | 1/42 (2.4%) | 3/39 (7.7%) | ||||
| Infections and infestations | ||||||||
| Upper respiratory tract infection | 0/41 (0%) | 2/39 (5.1%) | 3/42 (7.1%) | 1/39 (2.6%) | ||||
| Nervous system disorders | ||||||||
| Headache | 5/41 (12.2%) | 4/39 (10.3%) | 8/42 (19%) | 7/39 (17.9%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
| Name/Title | Therapeutic Area Head |
|---|---|
| Organization | Allergan, Inc |
| Phone | 714-246-4500 |
| IR-CTRegistration@allergan.com |
Responsible Party:
Allergan
ClinicalTrials.gov Identifier:
NCT02595528
Other Study ID Numbers:
- 199201-009
First Posted:
Nov 3, 2015
Last Update Posted:
Dec 22, 2020
Last Verified:
Nov 1, 2020