Safety and Efficacy of ENV515 Travoprost Extended Release (XR) in Patients With Bilateral Ocular Hypertension or Primary Open Angle Glaucoma
Sponsor
Envisia Therapeutics (Industry)
Overall Status
Completed
CT.gov ID
NCT02371746
Collaborator
(none)
41
14
3
49.4
2.9
0.1
Study Details
Study Description
Brief Summary
This is a multiple cohort study that will evaluate the safety and efficacy of ENV515 travoprost XR in patients with open-angle glaucoma or ocular hypertension.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
41 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multi-Center, Three-Stage, Open-Label, Prospective, Active-Comparator-Controlled Phase 2a Study of ENV515 (Travoprost) Intracameral Implant in Patients With Bilateral Ocular Hypertension or Early Primary Open-Angle Glaucoma
Actual Study Start Date
:
Jan 1, 2015
Actual Primary Completion Date
:
Feb 13, 2019
Actual Study Completion Date
:
Feb 13, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort 1 ENV515-1 and ENV515-3 implants in Study Eye for 28 days |
Drug: ENV515-3 Travoprost XR
Drug: ENV515-1 Travoprost XR
|
| Experimental: Cohort 2 Two ENV515-3 implants in Study Eye for 12 months with optional 6 month and 3 month extensions (total of 21 months) |
Drug: ENV515-3 Travoprost XR
|
| Experimental: Cohort 3 One or two ENV515-3-2 implants in Study Eye with optional 6 months and additional 6 month extension (total of 24 months) |
Drug: ENV515-3-2 Travoprost XR
|
Outcome Measures
Primary Outcome Measures
- Summary of Change From Baseline Average Intraocular Pressure Diurnal Measurement by Treatment Group Population (Cohort 1) [Baseline and Day 25]
Average intraocular pressure (IOP) diurnal measurement is calculated by taking the average of the intraocular pressure measurements at 8AM, 10AM and 4PM. The protocol was later amended (Amendment 09) to a safety only study so the diurnal measurements were no longer collected for Cohorts 2 and 3; only the 8AM IOP was collected as a safety assessment only.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Diagnosis of either ocular hypertension or open angle glaucoma in both eyes.
-
Are currently treated with topical PGA for ocular hypertension in both eyes.
-
Patients who in the opinion of the Investigator: have an IOP in both eyes that is considered to be adequately controlled, can be safely withdrawn from IOP medications in both eyes during the washout period, and who are not considered to be at significant risk for disease progression throughout the trial.
Exclusion Criteria:
-
Eye surgery (including cataract surgery) within the past 3 months.
-
History of glaucoma related surgery.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chandler | Arizona | United States | 85225 | |
| 2 | Garden Grove | California | United States | 92843 | |
| 3 | Inglewood | California | United States | 90301 | |
| 4 | Redding | California | United States | 96002 | |
| 5 | Morrow | Georgia | United States | 30260 | |
| 6 | Indianapolis | Indiana | United States | 46260 | |
| 7 | Chesterfield | Missouri | United States | 63017 | |
| 8 | Kansas City | Missouri | United States | 64133 | |
| 9 | Cincinnati | Ohio | United States | 45242 | |
| 10 | Portland | Oregon | United States | 97210 | |
| 11 | Sioux Falls | South Dakota | United States | 57108 | |
| 12 | Austin | Texas | United States | 78731 | |
| 13 | Houston | Texas | United States | 77025 | |
| 14 | San Antonio | Texas | United States | 78229 |
Sponsors and Collaborators
- Envisia Therapeutics
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Envisia Therapeutics
ClinicalTrials.gov Identifier:
NCT02371746
Other Study ID Numbers:
- ENV515-01
First Posted:
Feb 26, 2015
Last Update Posted:
Oct 17, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Cohort 1 - Group 1 | Cohort 1 - Group 2 | Cohort 1 - Group 3 | Cohort 1 - Group 4 | Cohort 2 | Cohort 3 - Group 1 | Cohort 3 - Group 2 |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | 2 ENV515-3 implants (28.2 μg travoprost) in Study Eye for 28 days | 3 ENV515-3 implants (42.3 μg travoprost) in Study Eye for 28 days | 1 ENV515-1 implant (42.5 μg travoprost) in Study Eye for 28 days | 2 ENV515-1 implants (85.0 μg travoprost) in Study Eye for 28 days | 2 ENV515-3 implants (28.2 μg travoprost) in Study Eye for up to 21 months | 1 ENV515-3-2 implant (26.1 μg travoprost) in Study Eye for up to 24 months | 2 ENV515-3-2 implants (52.2 μg travoprost) in Study Eye for up to 24 months |
| Period Title: Overall Study | |||||||
| STARTED | 7 | 10 | 2 | 2 | 5 | 6 | 9 |
| COMPLETED | 7 | 10 | 2 | 2 | 5 | 6 | 8 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | Cohort 1 - Group 1 | Cohort 1 - Group 2 | Cohort 1 - Group 3 | Cohort 1 - Group 4 | Cohort 2 | Cohort 3 - Group 1 | Cohort 3 - Group 2 | Total |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 2 ENV515-3 implants (28.2 μg travoprost) in Study Eye for 28 days | 3 ENV515-3 implants (42.3 μg travoprost) in Study Eye for 28 days | 1 ENV515-1 implant (42.5 μg travoprost) in Study Eye for 28 days | 2 ENV515-3 implants (85.0 μg travoprost) in Study Eye for 28 days | 2 ENV515-3 implants (28.2 μg travoprost) in Study Eye for up to 21 months | 1 ENV515-3-2 implant (26.1 μg travoprost) in Study Eye for up to 24 months | 2 ENV515-3-2 implants (52.2 μg travoprost) in Study Eye for up to 24 months | Total of all reporting groups |
| Overall Participants | 7 | 10 | 2 | 2 | 5 | 6 | 9 | 41 |
| Age (Count of Participants) | ||||||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
0
0%
|
1
10%
|
0
0%
|
1
50%
|
3
60%
|
5
83.3%
|
3
33.3%
|
13
31.7%
|
| >=65 years |
7
100%
|
9
90%
|
2
100%
|
1
50%
|
2
40%
|
1
16.7%
|
6
66.7%
|
28
68.3%
|
| Age (Years) [Mean (Standard Deviation) ] | ||||||||
| Cohort 1 |
74.32
(4.729)
|
71.99
(4.213)
|
71.29
(7.128)
|
62.46
(8.188)
|
71.79
(5.619)
|
|||
| Cohorts 2 and 3 |
57.412
(11.4833)
|
59.472
(7.2299)
|
64.462
(10.4534)
|
61.203
(9.8634)
|
||||
| Sex: Female, Male (Count of Participants) | ||||||||
| Female |
5
71.4%
|
3
30%
|
2
100%
|
2
100%
|
4
80%
|
2
33.3%
|
6
66.7%
|
24
58.5%
|
| Male |
2
28.6%
|
7
70%
|
0
0%
|
0
0%
|
1
20%
|
4
66.7%
|
3
33.3%
|
17
41.5%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||||||
| Hispanic or Latino |
2
28.6%
|
0
0%
|
0
0%
|
1
50%
|
1
20%
|
0
0%
|
0
0%
|
4
9.8%
|
| Not Hispanic or Latino |
5
71.4%
|
10
100%
|
2
100%
|
1
50%
|
4
80%
|
6
100%
|
9
100%
|
37
90.2%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
1
10%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
2.4%
|
| Black or African American |
0
0%
|
2
20%
|
0
0%
|
0
0%
|
0
0%
|
1
16.7%
|
2
22.2%
|
5
12.2%
|
| White |
7
100%
|
7
70%
|
2
100%
|
2
100%
|
5
100%
|
5
83.3%
|
7
77.8%
|
35
85.4%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (Count of Participants) | ||||||||
| United States |
7
100%
|
10
100%
|
2
100%
|
2
100%
|
5
100%
|
6
100%
|
9
100%
|
41
100%
|
| Intraocular Pressure (mm Hg) (mm Hg) [Mean (Standard Deviation) ] | ||||||||
| Cohort 1 |
24.57
(2.370)
|
24.12
(2.277)
|
24.83
(3.064)
|
26.67
(1.414)
|
24.58
(2.267)
|
|||
| Cohorts 2 and 3 |
26.2
(2.39)
|
28.2
(2.99)
|
25.2
(1.56)
|
26.4
(2.50)
|
||||
Outcome Measures
| Title | Summary of Change From Baseline Average Intraocular Pressure Diurnal Measurement by Treatment Group Population (Cohort 1) |
|---|---|
| Description | Average intraocular pressure (IOP) diurnal measurement is calculated by taking the average of the intraocular pressure measurements at 8AM, 10AM and 4PM. The protocol was later amended (Amendment 09) to a safety only study so the diurnal measurements were no longer collected for Cohorts 2 and 3; only the 8AM IOP was collected as a safety assessment only. |
| Time Frame | Baseline and Day 25 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | Cohort 1 - Group 1 | Cohort 1 - Group 2 | Cohort 1 - Group 3 | Cohort 1 - Group 4 | Cohort 2 | Cohort 3 - Group 1 | Cohort 3 - Group 2 |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | 2 ENV515-3 implants (28.2 μg travoprost) in Study Eye for 28 days | 3 ENV515-3 implants (42.3 μg travoprost) in Study Eye for 28 days | 1 ENV515-1 implant (42.5 μg travoprost) in Study Eye for 28 days | 2 ENV515-1 implants (85.0 μg travoprost) in Study Eye for 28 days | 2 ENV515-3 implants (28.2 μg travoprost) in Study Eye for up to 21 months | 1 ENV515-3-2 implant (28.2 μg travoprost) in Study Eye for for up to 24 months | 2 ENV515-3-2 implants (52.2 μg travoprost) in Study Eye for up to 24 months |
| Measure Participants | 7 | 10 | 2 | 2 | 0 | 0 | 0 |
| Mean (Standard Deviation) [mm Hg] |
-5.10
(1.707)
|
-6.65
(2.076)
|
-3.17
(1.179)
|
-5.67
(0.000)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Cohort 1 - Group 1, Cohort 1 - Group 2, Cohort 1 - Group 3, Cohort 1 - Group 4 |
|---|---|---|
| Comments | estimatCohort 1 all Groups: Non-study eye: TRAVANTAN Z Cohort 1 - Group 1: Study Eye: 28.2 ug travoprost Cohort 1 - Group 2: Study Eye: 42.3 ug travoprost Cohort 1 - Group 3: Study Eye: 42 .5 ug travoprost Cohort 1 - Group 4: Study Eye: 85.0 ug travoprost | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Change from baseline |
| Estimated Value | 30.4 | |
| Confidence Interval |
(2-Sided) 95% -1.8 to 36.6 |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 1.84 |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment. | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit. | |||||||||||||
| Arm/Group Title | Cohort 1 - Group 1 | Cohort 1 - Group 2 | Cohort 2 - Group 3 | Cohort 1 - Group 4 | Cohort 2 | Cohort 3 - Group 1 | Cohort 3 - Group 2 | |||||||
| Arm/Group Description | 2 ENV515-3 implants (28.2 μg travoprost) in Study Eye for 28 days | 3 ENV515-3 implants (42.3 μg travoprost) in Study Eye for 28 days | 1 ENV515-1 implant (42.5 μg travoprost) in Study Eye for 28 days | 2 ENV515-1 implants (85.0 μg travoprost) in Study Eye for 28 days | 2 ENV515-3 implants (28.2 μg travoprost) in Study Eye for up to 21 months | 1 ENV515-3-2 implant (26.1 μg travoprost) in Study Eye for up to 24 months | 2 ENV515-3-2 implants (52.2 μg travoprost) in Study Eye for up to 24 months | |||||||
All Cause Mortality |
||||||||||||||
| Cohort 1 - Group 1 | Cohort 1 - Group 2 | Cohort 2 - Group 3 | Cohort 1 - Group 4 | Cohort 2 | Cohort 3 - Group 1 | Cohort 3 - Group 2 | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | |||||||
Serious Adverse Events |
||||||||||||||
| Cohort 1 - Group 1 | Cohort 1 - Group 2 | Cohort 2 - Group 3 | Cohort 1 - Group 4 | Cohort 2 | Cohort 3 - Group 1 | Cohort 3 - Group 2 | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/7 (0%) | 1/10 (10%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 4/9 (44.4%) | |||||||
| Eye disorders | ||||||||||||||
| Corneal edema | 0/7 (0%) | 0 | 0/10 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 |
| Corneal endothelial cell loss | 0/7 (0%) | 0 | 1/10 (10%) | 1 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/9 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||
| Cervical spinal stenosis | 0/7 (0%) | 0 | 0/10 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||
| Paget's disease of the right nipple | 0/7 (0%) | 0 | 0/10 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 |
| Nervous system disorders | ||||||||||||||
| Spinal cord compression | 0/7 (0%) | 0 | 0/10 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 |
| Reproductive system and breast disorders | ||||||||||||||
| Cystocele | 0/7 (0%) | 0 | 0/10 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/9 (11.1%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||||||||||
| Cohort 1 - Group 1 | Cohort 1 - Group 2 | Cohort 2 - Group 3 | Cohort 1 - Group 4 | Cohort 2 | Cohort 3 - Group 1 | Cohort 3 - Group 2 | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/7 (57.1%) | 7/10 (70%) | 2/2 (100%) | 2/2 (100%) | 5/5 (100%) | 6/6 (100%) | 9/9 (100%) | |||||||
| Blood and lymphatic system disorders | ||||||||||||||
| Haemorrhagic anaemia | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | |||||||
| Ear and labyrinth disorders | ||||||||||||||
| Meniere's disease | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | |||||||
| Vertigo | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | |||||||
| Eye disorders | ||||||||||||||
| Anterior chamber cell | 1/7 (14.3%) | 2/10 (20%) | 0/2 (0%) | 1/2 (50%) | 1/5 (20%) | 0/6 (0%) | 2/9 (22.2%) | |||||||
| Anterior chamber flare | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | |||||||
| Anterior chamber inflammation | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 2/9 (22.2%) | |||||||
| Blepharitis | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | |||||||
| Cataract | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 3/9 (33.3%) | |||||||
| Chalazion | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 2/6 (33.3%) | 0/9 (0%) | |||||||
| Conjunctival haemorrhage | 1/7 (14.3%) | 3/10 (30%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | |||||||
| Conjunctival hyperaemia | 1/7 (14.3%) | 3/10 (30%) | 0/2 (0%) | 0/2 (0%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | |||||||
| Conjunctival oedema | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | |||||||
| Conjunctivitis allergic | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | |||||||
| Corneal edema | 0/7 (0%) | 1/10 (10%) | 1/2 (50%) | 1/2 (50%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | |||||||
| Corneal endothelial cell loss | 0/7 (0%) | 1/10 (10%) | 0/2 (0%) | 0/2 (0%) | 2/5 (40%) | 2/6 (33.3%) | 4/9 (44.4%) | |||||||
| Corneal epithelial microcysts | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 2/9 (22.2%) | |||||||
| Corneal opacity | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | |||||||
| Corneal thickening | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | |||||||
| Eye allergy | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | |||||||
| Eye inflammation | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | |||||||
| Eye irritation | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | |||||||
| Eye pain | 0/7 (0%) | 1/10 (10%) | 0/2 (0%) | 0/2 (0%) | 1/5 (20%) | 1/6 (16.7%) | 1/9 (11.1%) | |||||||
| Eye pruritis | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | |||||||
| Eyelid oedema | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | |||||||
| Eyelid ptosis | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 1/2 (50%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | |||||||
| Foreign body sensation in eyes | 1/7 (14.3%) | 3/10 (30%) | 2/2 (100%) | 1/2 (50%) | 4/5 (80%) | 3/6 (50%) | 2/9 (22.2%) | |||||||
| Iris adhesions | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 1/6 (16.7%) | 2/9 (22.2%) | |||||||
| Iris disorder | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | |||||||
| Iritis | 0/7 (0%) | 2/10 (20%) | 0/2 (0%) | 1/2 (50%) | 1/5 (20%) | 3/6 (50%) | 4/9 (44.4%) | |||||||
| Keratitis | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | |||||||
| Lacrimation increased | 0/7 (0%) | 3/10 (30%) | 1/2 (50%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | |||||||
| Macular degeneration | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | |||||||
| Narrow anterior chamber angle | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | |||||||
| Ocular discomfort | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 1/5 (20%) | 0/6 (0%) | 2/9 (22.2%) | |||||||
| Ocular hyperaemia | 4/7 (57.1%) | 3/10 (30%) | 2/2 (100%) | 1/2 (50%) | 4/5 (80%) | 4/6 (66.7%) | 4/9 (44.4%) | |||||||
| Optic disc haemorrhage | 1/7 (14.3%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | |||||||
| Photophobia | 0/7 (0%) | 2/10 (20%) | 0/2 (0%) | 1/2 (50%) | 1/5 (20%) | 1/6 (16.7%) | 3/9 (33.3%) | |||||||
| Photopsia | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 1/6 (16.7%) | 1/9 (11.1%) | |||||||
| Posterior capsule opacification | 0/7 (0%) | 2/10 (20%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | |||||||
| Punctate keratitis | 3/7 (42.9%) | 1/10 (10%) | 2/2 (100%) | 1/2 (50%) | 2/5 (40%) | 0/6 (0%) | 0/9 (0%) | |||||||
| Recession of chamber angle of eye | 0/7 (0%) | 0/10 (0%) | 1/2 (50%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | |||||||
| Trichiasis | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | |||||||
| Vision blurred | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 2/5 (40%) | 0/6 (0%) | 0/9 (0%) | |||||||
| Visual acuity reduced | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | |||||||
| Vitreous floaters | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | |||||||
| Gastrointestinal disorders | ||||||||||||||
| Dental caries | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | |||||||
| Gastroesophageal reflux disease | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | |||||||
| Hiatus hernia | 0/7 (0%) | 1/10 (10%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | |||||||
| Large intestinal polyp | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | |||||||
| Nausea | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | |||||||
| Vomiting | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | |||||||
| General disorders | ||||||||||||||
| Chest pain | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | |||||||
| Instillation site pain | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | |||||||
| Oedema peripheral | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | |||||||
| Immune system disorders | ||||||||||||||
| Drug hypersensitivity | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | |||||||
| Seasonal allergy | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 1/5 (20%) | 0/6 (0%) | 1/9 (11.1%) | |||||||
| Infections and infestations | ||||||||||||||
| Bacterial infection | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | |||||||
| Bronchitis | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 1/5 (20%) | 1/6 (16.7%) | 0/9 (0%) | |||||||
| Conjunctivitis | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | |||||||
| Cystitis | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | |||||||
| Diverticulitis | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | |||||||
| Gingivitis | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | |||||||
| Herpes zoster | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 2/6 (33.3%) | 0/9 (0%) | |||||||
| Influenza | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 1/6 (16.7%) | 2/9 (22.2%) | |||||||
| Nasopharyngitis | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 1/6 (16.7%) | 1/9 (11.1%) | |||||||
| Oral herpes | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 1/2 (50%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | |||||||
| Pneumonia | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | |||||||
| Sinusitis | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 2/5 (40%) | 1/6 (16.7%) | 0/9 (0%) | |||||||
| Upper respiratory track infection | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 1/5 (20%) | 1/6 (16.7%) | 1/9 (11.1%) | |||||||
| Vulvovaginal mycotic infection | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | |||||||
| Injury, poisoning and procedural complications | ||||||||||||||
| Arthropod bite | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | |||||||
| Arthropod sting | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | |||||||
| Fall | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | |||||||
| Head injury | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | |||||||
| Limb injury | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | |||||||
| Meniscus injury | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | |||||||
| Procedural haemorrhage | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | |||||||
| Procedural pain | 1/7 (14.3%) | 1/10 (10%) | 1/2 (50%) | 1/2 (50%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | |||||||
| Investigations | ||||||||||||||
| Alanine aminotransferase increased | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | |||||||
| Eosinophil count increased | 0/7 (0%) | 1/10 (10%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | |||||||
| Intraocular pressure increased | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 1/6 (16.7%) | 1/9 (11.1%) | |||||||
| Metabolism and nutrition disorders | ||||||||||||||
| Diabetes mellitus | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 1/5 (20%) | 0/6 (0%) | 3/9 (33.3%) | |||||||
| Hypercholesterolemia | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 2/9 (22.2%) | |||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||
| Arthritis | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | |||||||
| Bursitis | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 1/5 (20%) | 1/6 (16.7%) | 0/9 (0%) | |||||||
| Intervertebral disc protrusion | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | |||||||
| Muscle spasms | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | |||||||
| Neck pain | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | |||||||
| Osteoarthritis | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | |||||||
| Osteopenia | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | |||||||
| Rheumatoid arthritis | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | |||||||
| Tendonitis | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | |||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||
| Breast cancer | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | |||||||
| Nervous system disorders | ||||||||||||||
| Headache | 0/7 (0%) | 1/10 (10%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 0/9 (0%) | |||||||
| Visual field defect | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | |||||||
| Psychiatric disorders | ||||||||||||||
| Depression | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | |||||||
| Renal and urinary disorders | ||||||||||||||
| Bladder prolapse | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | |||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||
| Cough | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 1/5 (20%) | 0/6 (0%) | 3/9 (33.3%) | |||||||
| Dyspnoea | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 1/5 (20%) | 0/6 (0%) | 0/9 (0%) | |||||||
| Oropharyngeal pain | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 2/5 (40%) | 0/6 (0%) | 1/9 (11.1%) | |||||||
| Upper respiratory tract congestion | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 1/6 (16.7%) | 0/9 (0%) | |||||||
| Vascular disorders | ||||||||||||||
| Hyperemia | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 1/6 (16.7%) | 2/9 (22.2%) | |||||||
| Hypertension | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 2/5 (40%) | 2/6 (33.3%) | 0/9 (0%) | |||||||
| Hypotension | 0/7 (0%) | 0/10 (0%) | 0/2 (0%) | 0/2 (0%) | 0/5 (0%) | 0/6 (0%) | 1/9 (11.1%) | |||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
| Name/Title | Kristin Blackwell, Consultant, Regulatory Affairs & Quality Assurance |
|---|---|
| Organization | Envisia Therapeutics, Inc. |
| Phone | 919-219-6448 |
| kristin.blackwell@envtx.com |
Responsible Party:
Envisia Therapeutics
ClinicalTrials.gov Identifier:
NCT02371746
Other Study ID Numbers:
- ENV515-01
First Posted:
Feb 26, 2015
Last Update Posted:
Oct 17, 2019
Last Verified:
Sep 1, 2019