Trial Outcomes & Findings for Safety and Performance of Miami InnFocus Drainage Implant (MIDI Arrow) Glaucoma Drainage Implant (NCT NCT01563237)
NCT ID: NCT01563237
Last Updated: 2021-06-24
Results Overview
The rate of success reflected sustained control of IOP over 24 Months from baseline
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
69 participants
Primary outcome timeframe
Months 6, 9, 12 and 24
Results posted on
2021-06-24
Participant Flow
Listing of Eyes under Study
Unit of analysis: Eyes
Participant milestones
| Measure |
First Studied Eye
Patients suffering from glaucoma that is inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 40 mm Hg.
|
Second Studied Eye
Patients suffering from glaucoma that is inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 40 mm Hg.
|
|---|---|---|
|
Overall Study
STARTED
|
64 69
|
5 5
|
|
Overall Study
COMPLETED
|
54 59
|
5 5
|
|
Overall Study
NOT COMPLETED
|
10 10
|
0 0
|
Reasons for withdrawal
| Measure |
First Studied Eye
Patients suffering from glaucoma that is inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 40 mm Hg.
|
Second Studied Eye
Patients suffering from glaucoma that is inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 40 mm Hg.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Medical Reasons
|
1
|
0
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
Safety and Performance of Miami InnFocus Drainage Implant (MIDI Arrow) Glaucoma Drainage Implant
Baseline characteristics by cohort
| Measure |
MIDI Arrow
n=67 Participants
Implantation of MIDI Arrow (MicroShunt) in the anterior chamber of the eye in patients with primary open angle glaucoma (POAG)
|
|---|---|
|
Age, Continuous
|
64.1 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
67 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Months 6, 9, 12 and 24Population: The Intent-to-Treat (ITT) population included all enrolled eyes who have signed the informed consent and attended the procedure visit to receive the assigned therapy under evaluation (MIDI Arrow).
The rate of success reflected sustained control of IOP over 24 Months from baseline
Outcome measures
| Measure |
Success With Respect to IOP
n=72 Implanted eyes
The rates of success reflected sustained control of IOP
|
|---|---|
|
Number of Eyes With Study Success
Month 6
|
50 Implanted eyes
|
|
Number of Eyes With Study Success
Month 9
|
52 Implanted eyes
|
|
Number of Eyes With Study Success
Month 12
|
50 Implanted eyes
|
|
Number of Eyes With Study Success
Month 24
|
51 Implanted eyes
|
SECONDARY outcome
Timeframe: At Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12 and Month 24Population: The Intent-to-Treat (ITT) population included all enrolled subject who have signed the informed consent and attended the procedure visit to receive the assigned therapy under evaluation (MIDI Arrow). IOP data collected after glaucoma re-operation was censored for this analysis
Intraocular Pressure (IOP) change in studied eye compared to baseline value at all timepoints thru 24 Months.
Outcome measures
| Measure |
Success With Respect to IOP
n=72 eyes
The rates of success reflected sustained control of IOP
|
|---|---|
|
IOP Change From Baseline
Month 12
|
15.6 mmHg
Standard Deviation 4.7
|
|
IOP Change From Baseline
IOP at Baseline
|
26 mmHg
Standard Deviation 7
|
|
IOP Change From Baseline
Day 1
|
9.2 mmHg
Standard Deviation 4.2
|
|
IOP Change From Baseline
Day 7
|
10.9 mmHg
Standard Deviation 5.2
|
|
IOP Change From Baseline
Week 3
|
13.2 mmHg
Standard Deviation 6.3
|
|
IOP Change From Baseline
Week 6
|
13.3 mmHg
Standard Deviation 5.2
|
|
IOP Change From Baseline
Month 3
|
13.8 mmHg
Standard Deviation 4.1
|
|
IOP Change From Baseline
Month 6
|
15 mmHg
Standard Deviation 3.9
|
|
IOP Change From Baseline
Month 9
|
15.4 mmHg
Standard Deviation 4.2
|
|
IOP Change From Baseline
Month 24
|
16.2 mmHg
Standard Deviation 5.8
|
Adverse Events
Study Eyes Selected to be Operated Within the Study
Serious events: 10 serious events
Other events: 68 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Study Eyes Selected to be Operated Within the Study
n=74 participants at risk
Patients suffering from glaucoma that is inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 40 mm Hg.
|
|---|---|
|
Investigations
Intraocular Pressure Increased
|
4.1%
3/74 • Number of events 3 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Surgical and medical procedures
Gallbladder Operation
|
1.4%
1/74 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Surgical and medical procedures
Medical Device Repositioning
|
1.4%
1/74 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Eye disorders
Macular Degeneration
|
1.4%
1/74 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Eye disorders
Macular Oedema
|
1.4%
1/74 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Eye disorders
Visual Acuity Reduced
|
1.4%
1/74 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Injury, poisoning and procedural complications
Conjunctival Filtering Bleb Leak
|
1.4%
1/74 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Hepatobiliary disorders
Perforation Bile Duct
|
1.4%
1/74 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Infections and infestations
Dacryocystitis
|
1.4%
1/74 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
Other adverse events
| Measure |
Study Eyes Selected to be Operated Within the Study
n=74 participants at risk
Patients suffering from glaucoma that is inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 40 mm Hg.
|
|---|---|
|
Investigations
Intraocular pressure increased
|
52.7%
39/74 • Number of events 64 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Eye disorders
Hyphaema
|
25.7%
19/74 • Number of events 19 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Eye disorders
Hypotony of eye
|
17.6%
13/74 • Number of events 15 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Eye disorders
Cataract
|
23.0%
17/74 • Number of events 17 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Eye disorders
Macular oedema
|
4.1%
3/74 • Number of events 6 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Eye disorders
Diplopia
|
2.7%
2/74 • Number of events 2 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Eye disorders
Keratitis
|
16.2%
12/74 • Number of events 12 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Eye disorders
Visual acuity reduced
|
5.4%
4/74 • Number of events 6 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Eye disorders
Eye irritation
|
6.8%
5/74 • Number of events 6 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Eye disorders
Ulcerative keratitis
|
6.8%
5/74 • Number of events 6 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Eye disorders
Eyelid ptosis
|
5.4%
4/74 • Number of events 4 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Eye disorders
Conjunctival haemorrhage
|
2.7%
2/74 • Number of events 2 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Eye disorders
Iris adhesions
|
2.7%
2/74 • Number of events 2 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Eye disorders
Conjunctivitis allergic
|
2.7%
2/74 • Number of events 2 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Eye disorders
Dry eye
|
1.4%
1/74 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Eye disorders
Retinopathy
|
2.7%
2/74 • Number of events 2 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Eye disorders
Eyelid irritation
|
1.4%
1/74 • Number of events 2 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Eye disorders
Allergic Keratitis
|
1.4%
1/74 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Eye disorders
Blepharitis
|
1.4%
1/74 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Eye disorders
Blepharospasm
|
1.4%
1/74 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Eye disorders
Choroidal detachment
|
1.4%
1/74 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Eye disorders
Corneal irritation
|
1.4%
1/74 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Eye disorders
Dacryostenosis acquired
|
1.4%
1/74 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Eye disorders
Eye Haemorrhage
|
1.4%
1/74 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Eye disorders
Eye Pain
|
1.4%
1/74 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Eye disorders
Lacrimal Disorder
|
1.4%
1/74 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Eye disorders
Macular Degeneration
|
1.4%
1/74 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Eye disorders
Narrow Anterior Chamber Angle
|
1.4%
1/74 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Eye disorders
Trichiasis
|
1.4%
1/74 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Investigations
Intraocular Pressure Decreased
|
2.7%
2/74 • Number of events 2 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
General disorders
Drug Intolerance
|
9.5%
7/74 • Number of events 7 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Injury, poisoning and procedural complications
Conjunctival Abrasion
|
1.4%
1/74 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Injury, poisoning and procedural complications
Conjunctival Filtering Bleb Leak
|
1.4%
1/74 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Injury, poisoning and procedural complications
Conjunctival Scar
|
1.4%
1/74 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Injury, poisoning and procedural complications
Procedural Haemorrhage
|
1.4%
1/74 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Injury, poisoning and procedural complications
Suture Related Complication
|
1.4%
1/74 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Infections and infestations
Conjunctivitis
|
4.1%
3/74 • Number of events 3 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Infections and infestations
Dacryocystitis
|
1.4%
1/74 • Number of events 2 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Infections and infestations
Infection
|
1.4%
1/74 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Infections and infestations
Sinusitis
|
1.4%
1/74 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Nervous system disorders
Visual Field Defect
|
2.7%
2/74 • Number of events 2 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Product Issues
Device Deployment Issue
|
4.1%
3/74 • Number of events 3 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Product Issues
Device Difficult To Use
|
1.4%
1/74 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Product Issues
Device Occlusion
|
1.4%
1/74 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Surgical and medical procedures
Gallbladder Operation
|
1.4%
1/74 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Surgical and medical procedures
Medical Device Repositioning
|
1.4%
1/74 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Surgical and medical procedures
Suture Removal
|
1.4%
1/74 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
|
Hepatobiliary disorders
Perforation Bile Duct
|
1.4%
1/74 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study of 24 Months.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) affecting the study eye. Adverse Events were collected and reported per eye.
|
Additional Information
Sharon Herbert, Associate Director of Clinical Operations
InnFocus, Inc.
Phone: (415) 268-9059
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place