A Safety, Efficacy and Pharmacokinetic Study of AGN-199201 and AGN-190584 in Patients With Presbyopia
Sponsor
Allergan (Industry)
Overall Status
Completed
CT.gov ID
NCT02780115
Collaborator
(none)
151
25
5
17.2
6
0.4
Study Details
Study Description
Brief Summary
This is a safety, efficacy and pharmacokinetics study of the fixed combination of AGN-199201 and AGN-190584 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
:
151 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety, Efficacy, and Pharmacokinetics of the Fixed Combination of AGN-199201 and AGN-190584 in Patients With Presbyopia
Actual Study Start Date
:
May 26, 2016
Actual Primary Completion Date
:
Oct 31, 2017
Actual Study Completion Date
:
Oct 31, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort 1: Vehicle Control Vehicle dosed in both eyes administered once daily during office visits 1 through 5. |
Drug: AGN-199201 Vehicle
Vehicle to AGN-199201
Drug: AGN-190584 Vehicle
Vehicle to AGN-190584
|
| Experimental: Cohort 2: AGN-199201 Dose A and AGN-190584 Dose A Fixed combinations of AGN-199201 Dose A and AGN-190584 Dose A dosed in both eyes administered once daily during office visits 1 through 5. |
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 of AGN-190584 ophthalmic solution Doses A, B, C in the eye.
|
| Experimental: Cohort 3: AGN-199201 Dose B and AGN-190584 Dose B Fixed combinations of AGN-199201 Dose B and AGN-190584 Dose B dosed in both eyes administered once daily during office visits 1 through 5. |
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 of AGN-190584 ophthalmic solution Doses A, B, C in the eye.
|
| Experimental: Cohort 4: AGN-199201 Dose C and AGN-190584 Dose C Fixed combinations of AGN-199201 Dose C and AGN-190584 Dose C dosed in both eyes administered once daily during office visits 1 through 5. |
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 of AGN-190584 ophthalmic solution Doses A, B, C in the eye.
|
| Experimental: Cohort 5: Vehicle, AGN-199201 Dose C and AGN-190584 Dose C Dominant eye dosed with Vehicle. Fixed combinations of AGN-199201 Dose C and AGN-190584 Dose C dosed in nondominant eye. Treatment administered once daily during office visits 1 through 5. |
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 of AGN-190584 ophthalmic solution Doses A, B, C in the eye.
Drug: AGN-199201 Vehicle
Vehicle to AGN-199201
Drug: AGN-190584 Vehicle
Vehicle to AGN-190584
|
Outcome Measures
Primary Outcome Measures
- Weighted Average Change From Baseline in Uncorrected Near Visual Acuity (UNVA) Letters in the Nondominant Eye [Baseline, Day 28]
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.
Secondary Outcome Measures
- Number of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs) [up to 65 days]
A Treatment Emergent Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Adverse Drug Reaction was a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded.
Eligibility Criteria
Criteria
Ages Eligible for Study:
40 Years
to 55 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 | Retina Institute of California Medical Group | Arcadia | California | United States | 91007 |
| 2 | Sall Research Medical Center | Artesia | California | United States | 90701 |
| 3 | WCCT Global, LLC | Cypress | California | United States | 90630 |
| 4 | Specialty Eye Care Medical Center | Glendale | California | United States | 91203 |
| 5 | Lugene Eye Institute | Glendale | California | United States | 91204 |
| 6 | The Eye Research Foundation | Newport Beach | California | United States | 92663 |
| 7 | Stanford Eye and Laser Center | Palo Alto | California | United States | 94303 |
| 8 | Wolstan and Golberg Eye Associates | Torrance | California | United States | 90505 |
| 9 | MedEye Associates | Miami | Florida | United States | 33143 |
| 10 | Central Florida Eye Institute | Ocala | Florida | United States | 34474 |
| 11 | Center for Sight | Sarasota | Florida | United States | 34239 |
| 12 | Clayton Eye Center | Morrow | Georgia | United States | 30260 |
| 13 | Silverstein Eye Centers | Louisville | Kentucky | United States | 40206 |
| 14 | The Eye Care Institute | Louisville | Kentucky | United States | 40206 |
| 15 | Specialized Eye Care | Baltimore | Maryland | United States | 21210 |
| 16 | James D. Branch | Winston-Salem | North Carolina | United States | 27101 |
| 17 | Devers Eye Institute | Portland | Oregon | United States | 97210 |
| 18 | Scott & Christie and Associates, PC | Cranberry Township | Pennsylvania | United States | 16066 |
| 19 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
| 20 | Total Eye Care, PA | Memphis | Tennessee | United States | 38119 |
| 21 | Cataract and Glaucoma Center | El Paso | Texas | United States | 79902 |
| 22 | University of Texas Medical Branch | Galveston | Texas | United States | 77555 |
| 23 | R and R Eye Research, LLC | San Antonio | Texas | United States | 78229 |
| 24 | Medical Center Ophthalmology Associates | San Antonio | Texas | United States | 78240 |
| 25 | Hoopes Durrie Rivera Research, LLC | Draper | Utah | United States | 84020 |
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:
NCT02780115
Other Study ID Numbers:
- 199201-010
First Posted:
May 23, 2016
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 | Cohort 1: Vehicle Control | Cohort 2: AGN-199201 Lower Dose and AGN-190584 Lower Dose | Cohort 3: AGN-199201 Medium Dose and AGN-190584 Medium Dose | Cohort 4: AGN-199201 Higher Dose and AGN-190584 Higher Dose | Cohort 5: Vehicle, AGN-199201 Higher Dose and AGN-190584 Higher Dose |
|---|---|---|---|---|---|
| Arm/Group Description | Vehicle dosed in both eyes administered once daily during office visits 1 through 5. | Fixed combinations of AGN-199201 Lower Dose and AGN-190584 Lower Dose dosed in both eyes administered once daily during office visits 1 through 5. | Fixed combinations of AGN-199201 Medium Dose and AGN-190584 Medium Dose dosed in both eyes administered once daily during office visits 1 through 5. | Fixed combinations of AGN-199201 Higher Dose and AGN-190584 Higher Dose dosed in both eyes administered once daily during office visits 1 through 5. | Dominant eye dosed with Vehicle. Fixed combinations of AGN-199201 Higher Dose and AGN-190584 Higher Dose dosed in nondominant eye. Treatment administered once daily during office visits 1 through 5. |
| Period Title: Overall Study | |||||
| STARTED | 28 | 30 | 30 | 32 | 31 |
| COMPLETED | 28 | 29 | 29 | 31 | 30 |
| NOT COMPLETED | 0 | 1 | 1 | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | Cohort 1: Vehicle Control | Cohort 2: AGN-199201 Lower Dose and AGN-190584 Lower Dose | Cohort 3: AGN-199201 Medium Dose and AGN-190584 Medium Dose | Cohort 4: AGN-199201 Higher Dose and AGN-190584 Higher Dose | Cohort 5: Vehicle, AGN-199201 Higher Dose and AGN-190584 Higher Dose | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | Vehicle dosed in both eyes administered once daily during office visits 1 through 5. | Fixed combinations of AGN-199201 Lower Dose and AGN-190584 Lower Dose dosed in both eyes administered once daily during office visits 1 through 5. | Fixed combinations of AGN-199201 Medium Dose and AGN-190584 Medium Dose dosed in both eyes administered once daily during office visits 1 through 5. | Fixed combinations of AGN-199201 Higher Dose and AGN-190584 Higher Dose dosed in both eyes administered once daily during office visits 1 through 5. | Dominant eye dosed with Vehicle. Fixed combinations of AGN-199201 Higher Dose and AGN-190584 Higher Dose dosed in nondominant eye. Treatment administered once daily during office visits 1 through 5. | Total of all reporting groups |
| Overall Participants | 28 | 30 | 30 | 32 | 31 | 151 |
| Age (Years) [Median (Standard Deviation) ] | ||||||
| Median (Standard Deviation) [Years] |
48.3
(3.9)
|
49.4
(2.7)
|
47.9
(3.9)
|
49.2
(3.8)
|
48.1
(3.4)
|
48.6
(3.6)
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
19
67.9%
|
20
66.7%
|
18
60%
|
25
78.1%
|
23
74.2%
|
105
69.5%
|
| Male |
9
32.1%
|
10
33.3%
|
12
40%
|
7
21.9%
|
8
25.8%
|
46
30.5%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||||
| Hispanic or Latino |
9
32.1%
|
10
33.3%
|
11
36.7%
|
9
28.1%
|
14
45.2%
|
53
35.1%
|
| Not Hispanic or Latino |
19
67.9%
|
20
66.7%
|
19
63.3%
|
23
71.9%
|
17
54.8%
|
98
64.9%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||||
| American Indian or Alaska Native |
1
3.6%
|
1
3.3%
|
0
0%
|
0
0%
|
0
0%
|
2
1.3%
|
| Asian |
0
0%
|
1
3.3%
|
0
0%
|
0
0%
|
1
3.2%
|
2
1.3%
|
| Native Hawaiian or Other Pacific Islander |
1
3.6%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
0.7%
|
| Black or African American |
3
10.7%
|
5
16.7%
|
5
16.7%
|
8
25%
|
4
12.9%
|
25
16.6%
|
| White |
23
82.1%
|
23
76.7%
|
25
83.3%
|
23
71.9%
|
26
83.9%
|
120
79.5%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
1
3.1%
|
0
0%
|
1
0.7%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Baseline UNVA severity (Count of Participants) | ||||||
| ≤ 20/80 |
20
71.4%
|
20
66.7%
|
18
60%
|
19
59.4%
|
22
71%
|
99
65.6%
|
| > 20/80 |
8
28.6%
|
10
33.3%
|
12
40%
|
13
40.6%
|
9
29%
|
52
34.4%
|
Outcome Measures
| Title | Weighted Average Change From Baseline in Uncorrected Near Visual Acuity (UNVA) Letters in the Nondominant Eye |
|---|---|
| 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, Day 28 |
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 | Cohort 1: Vehicle Control | Cohort 2: AGN-199201 Lower Dose and AGN-190584 Lower Dose | Cohort 3: AGN-199201 Medium Dose and AGN-190584 Medium Dose | Cohort 4: AGN-199201 Higher Dose and AGN-190584 Higher Dose | Cohort 5: Vehicle, AGN-199201 Higher Dose and AGN-190584 Higher Dose |
|---|---|---|---|---|---|
| Arm/Group Description | Vehicle dosed in both eyes administered once daily during office visits 1 through 5. | Fixed combinations of AGN-199201 Lower Dose and AGN-190584 Lower Dose dosed in both eyes administered once daily during office visits 1 through 5. | Fixed combinations of AGN-199201 Medium Dose and AGN-190584 Medium Dose dosed in both eyes administered once daily during office visits 1 through 5. | Fixed combinations of AGN-199201 Higher Dose and AGN-190584 Higher Dose dosed in both eyes administered once daily during office visits 1 through 5. | Dominant eye dosed with Vehicle. Fixed combinations of AGN-199201 Higher Dose and AGN-190584 Higher Dose dosed in nondominant eye. Treatment administered once daily during office visits 1 through 5. |
| Measure Participants | 28 | 30 | 30 | 32 | 31 |
| Least Squares Mean (Standard Error) [letters correctly read] |
3.00
(1.03)
|
4.96
(1.00)
|
7.77
(1.00)
|
7.54
(0.97)
|
7.81
(1.02)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Cohort 2: AGN-199201 Lower Dose and AGN-190584 Lower Dose |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1663 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Diff |
| Estimated Value | 1.96 | |
| Confidence Interval |
(2-Sided) 95% -0.83 to 4.74 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Cohort 3: AGN-199201 Medium Dose and AGN-190584 Medium Dose |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0009 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Diff |
| Estimated Value | 4.77 | |
| Confidence Interval |
(2-Sided) 95% 1.98 to 7.56 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Cohort 4: AGN-199201 Higher Dose and AGN-190584 Higher Dose |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0014 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Diff |
| Estimated Value | 4.54 | |
| Confidence Interval |
(2-Sided) 95% 1.79 to 7.29 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Cohort 5: Vehicle, AGN-199201 Higher Dose and AGN-190584 Higher Dose |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0008 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Diff |
| Estimated Value | 4.81 | |
| Confidence Interval |
(2-Sided) 95% 2.03 to 7.58 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs) |
|---|---|
| Description | A Treatment Emergent Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Adverse Drug Reaction was a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded. |
| Time Frame | up to 65 days |
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 | Cohort 1: Vehicle Control | Cohort 2: AGN-199201 Lower Dose and AGN-190584 Lower Dose | Cohort 3: AGN-199201 Medium Dose and AGN-190584 Medium Dose | Cohort 4: AGN-199201 Higher Dose and AGN-190584 Higher Dose | Cohort 5: Vehicle, AGN-199201 Higher Dose and AGN-190584 Higher Dose |
|---|---|---|---|---|---|
| Arm/Group Description | Vehicle dosed in both eyes administered once daily during office visits 1 through 5. | Fixed combinations of AGN-199201 Lower Dose and AGN-190584 Lower Dose dosed in both eyes administered once daily during office visits 1 through 5. | Fixed combinations of AGN-199201 Medium Dose and AGN-190584 Medium Dose dosed in both eyes administered once daily during office visits 1 through 5. | Fixed combinations of AGN-199201 Higher Dose and AGN-190584 Higher Dose dosed in both eyes administered once daily during office visits 1 through 5. | Dominant eye dosed with Vehicle. Fixed combinations of AGN-199201 Higher Dose and AGN-190584 Higher Dose dosed in nondominant eye. Treatment administered once daily during office visits 1 through 5. |
| Measure Participants | 28 | 30 | 30 | 32 | 31 |
| Count of Participants [Participants] |
8
28.6%
|
12
40%
|
15
50%
|
15
46.9%
|
10
32.3%
|
Adverse Events
| Time Frame | Adverse Events were collected for up to 65 days. | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Safety population: All patients who received ≥ 1 administration of study treatment | |||||||||
| Arm/Group Title | Cohort 1: Vehicle Control | Cohort 2: AGN-199201 Lower Dose and AGN-190584 Lower Dose | Cohort 3: AGN-199201 Medium Dose and AGN-190584 Medium Dose | Cohort 4: AGN-199201 Higher Dose and AGN-190584 Higher Dose | Cohort 5: Vehicle, AGN-199201 Higher Dose and AGN-190584 Higher Dose | |||||
| Arm/Group Description | Vehicle dosed in both eyes administered once daily during office visits 1 through 5. | Fixed combinations of AGN-199201 Lower Dose and AGN-190584 Lower Dose dosed in both eyes administered once daily during office visits 1 through 5. | Fixed combinations of AGN-199201 Medium Dose and AGN-190584 Medium Dose dosed in both eyes administered once daily during office visits 1 through 5. | Fixed combinations of AGN-199201 Higher Dose and AGN-190584 Higher Dose dosed in both eyes administered once daily during office visits 1 through 5. | Dominant eye dosed with Vehicle. Fixed combinations of AGN-199201 Higher Dose and AGN-190584 Higher Dose dosed in nondominant eye. Treatment administered once daily during office visits 1 through 5. | |||||
All Cause Mortality |
||||||||||
| Cohort 1: Vehicle Control | Cohort 2: AGN-199201 Lower Dose and AGN-190584 Lower Dose | Cohort 3: AGN-199201 Medium Dose and AGN-190584 Medium Dose | Cohort 4: AGN-199201 Higher Dose and AGN-190584 Higher Dose | Cohort 5: Vehicle, AGN-199201 Higher Dose and AGN-190584 Higher Dose | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/28 (0%) | 0/30 (0%) | 0/30 (0%) | 0/32 (0%) | 0/31 (0%) | |||||
Serious Adverse Events |
||||||||||
| Cohort 1: Vehicle Control | Cohort 2: AGN-199201 Lower Dose and AGN-190584 Lower Dose | Cohort 3: AGN-199201 Medium Dose and AGN-190584 Medium Dose | Cohort 4: AGN-199201 Higher Dose and AGN-190584 Higher Dose | Cohort 5: Vehicle, AGN-199201 Higher Dose and AGN-190584 Higher Dose | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/28 (0%) | 0/30 (0%) | 0/30 (0%) | 0/32 (0%) | 0/31 (0%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| Cohort 1: Vehicle Control | Cohort 2: AGN-199201 Lower Dose and AGN-190584 Lower Dose | Cohort 3: AGN-199201 Medium Dose and AGN-190584 Medium Dose | Cohort 4: AGN-199201 Higher Dose and AGN-190584 Higher Dose | Cohort 5: Vehicle, AGN-199201 Higher Dose and AGN-190584 Higher Dose | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 7/28 (25%) | 8/30 (26.7%) | 10/30 (33.3%) | 11/32 (34.4%) | 7/31 (22.6%) | |||||
| Eye disorders | ||||||||||
| Vision blurred | 0/28 (0%) | 2/30 (6.7%) | 3/30 (10%) | 3/32 (9.4%) | 2/31 (6.5%) | |||||
| General disorders | ||||||||||
| Instillation site pruritus | 0/28 (0%) | 4/30 (13.3%) | 0/30 (0%) | 1/32 (3.1%) | 2/31 (6.5%) | |||||
| Instillation site foreign body sensation | 3/28 (10.7%) | 3/30 (10%) | 1/30 (3.3%) | 0/32 (0%) | 1/31 (3.2%) | |||||
| Instillation site pain | 3/28 (10.7%) | 4/30 (13.3%) | 1/30 (3.3%) | 3/32 (9.4%) | 1/31 (3.2%) | |||||
| Instillation site lacrimation | 3/28 (10.7%) | 3/30 (10%) | 2/30 (6.7%) | 1/32 (3.1%) | 0/31 (0%) | |||||
| Infections and infestations | ||||||||||
| Upper respiratory tract infection | 1/28 (3.6%) | 0/30 (0%) | 5/30 (16.7%) | 1/32 (3.1%) | 1/31 (3.2%) | |||||
| Nervous system disorders | ||||||||||
| Headache | 3/28 (10.7%) | 5/30 (16.7%) | 6/30 (20%) | 10/32 (31.3%) | 6/31 (19.4%) | |||||
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 |
| Phone | 714-246-4500 |
| IR-CTRegistration@allergan.com |
Responsible Party:
Allergan
ClinicalTrials.gov Identifier:
NCT02780115
Other Study ID Numbers:
- 199201-010
First Posted:
May 23, 2016
Last Update Posted:
Dec 22, 2020
Last Verified:
Nov 1, 2020