A Prospective, Multicenter, Open Label Extension Study to Evaluate the Long Term Safety of OTX-TP
Phase: PHASE3
Conditions: Open Angle Glaucoma and Ocular Hypertension
Sponsor: Ocular Therapeutix, Inc.

TITLE: 
A PROSPECTIVE, MULTICENTER, OPEN LABEL 
EXTENSION STUDY TO EVALUATE THE LONG TERM 
SAFETY OF OTX-TP (SUSTAINED RELEASE 
TRAVOPROST INTRACANALICULAR INSERT) 
NCT#: NCT04061044 
DATE: JULY 11, 2019 

Hypertension, will receive OTX-TP in this trial to evaluate the long term 
safety of the OTX-TP drug product and will be followed for 
approximately 12 months.  
The study will be conducted at up to 15 qualified investigative sites in 
the United States.  
Study arms and treatments: 
OTX-TP: In the OTX-16-002 trial, subjects were randomized to receive 
either OTX-TP or a placebo vehicle. In this long term safety study, all 
subjects will receive OTX-TP in both eyes. Masking from the OTX-16-
002 will remain in place until all data review has been completed.  
Study Duration 
and Study Visits 
Each subject’s participation in the study is intended to last for 
approximately 12 months.  
Once a subject has successfully completed OTX-16-002, and has 
provided written informed consent, the subject will be screened for entry 
into this open label extension trial. Visit 1 is a screening and insertion 
visit that should take place within 7 days from when the subject exits the 
OTX-16-002 trial. This visit may be conducted on two separate days. At 
the end of Visit 1, subjects will have the OTX-TP intracanalicular insert 
placed in both eyes. 
Subjects in this study will not be randomized. All subjects will receive 
OTX-TP in both eyes. Subjects will be followed every 6 weeks during 
this study for approximately 12 months. 
All subjects will undergo follow-up visits at 1.5 months (Visit 2), 3 
months (Visit 3), 4.5 months (Visit 4), 6 months (Visit 5), 7.5 months 
(Visit 6), 9 months (Visit 7), 10.5 months (Visit 8), and 12 months (Visit 
9).  If at any visit, the investigator deems it necessary to initiate IOP-
lowering drops as rescue therapy due to an increase in IOP, the subject 
will begin the IOP-lowering drops at the Investigator’s discretion and 
continue to be followed until the intracanalicular insert is no longer 
present and patency is confirmed.   
Tear fluid samples will be collected at specified study visits, if possible.  
At visits where no insertion is required, tear fluid samples should be 
collected following the visualization assessment. At visits requiring an 
insertion, tear fluid samples should be collected approximately an hour 
prior to insertion, and again up to two hours post insertion.  
Insertions will be attempted at 3 months (Visit 3), 6 months (Visit 5), and 
9 months (Visit 7). Insert placement is to be performed after patency 
confirmation only if prior insert is not present, whether or not IOP is 
controlled. If IOP is controlled and insert is present, insertion may be 
deferred until the next study visit.  If IOP is not controlled and insert is 
present, the insert will be removed and another insert will be placed. 

If insertion is not successful at any visit, re-insertions may be attempted 
at the Investigator’s discretion within seven days of the failed attempt. If 
insertion is again unsuccessful, sites should discuss potential for re-
insertion with Ocular Therapeutix on a case by case basis. 
For subjects with Early Loss of Intracanalicular Insert: 
At any visit, including unscheduled visits, prior to the scheduled 
replacement visits (3 months, 6 months, and 9 months), if the 
intracanalicular insert is not visualized in one or both eyes by the 
Investigator, the Investigator will insert a new intracanalicular insert in 
the respective eye(s) after confirming patency. For any insert 
replacements, IOP assessments should be completed prior to 
replacement. The subject will continue to return for follow-up visits per 
the study schedule. The number of replacements will be tracked and 
documented on the appropriate Case Report Form (CRF). 
Inclusion Criteria Subjects must meet all of the following criteria to be eligible: 
- 
Had prior bilateral treatment and completion, through a minimum of 
week 12, of the OTX-16-002 trial  
- 
Are informed of the nature of the study and subject is able to comply 
with study requirements and visit schedule for one year  
- 
Have provided written informed consent, approved by the appropriate 
Institutional Review Board 
Exclusion 
Criteria 
Subjects who meet any of the following criteria are not eligible: 
- 
Had more than 1 replacement, per eye, during participation in the 
OTX-16-002 trial 
- 
Had punctal or canaliculi related adverse events during the OTX-16-
002 trial which required discontinuation (e.g., canaliculitis)  
- 
Used prohibited medications during the OTX-16-002 study, or the 
period between OTX-16-002 and this trial (with the exception of 
short term medication used to treat an adverse event or rescue 
therapy) 
- 
Missed more than 2 visits during participation in the OTX-16-002 
trial 
- 
Had IOP ≥ 34 mmHg at the Screening/Insertion Visit, or any visit 
during the OTX-16-002 trial 
- 
Require contact lens use at any point during the study including the 
Screening/Insertion Visit(s)  
- 
Have planned intraocular surgery or laser over the one year study 
period 
- 
Have a cup to disc ratio > 0.80 (horizontal or vertical measurement) 
in either eye 
- 
Are currently pregnant or breast-feeding or who wishes to become 
pregnant during the length of study participation 

- 
Are determined by the Investigator to be ineligible for reasons not 
already specified (e.g., systemic or other ocular disease/abnormality, 
not a candidate for topical prostaglandin, therapy, specifically 
travoprost) if the health of the subject or the validity of the study 
outcomes may be compromised by the subject’s enrollment 
- 
Are an employee of the site that is directly involved in the 
management, administration, or support of the study, or are an 
immediate family member of the same. 
- 
Are participating or plan to participate in any other investigational 
drug or device study during this study 
Pharmacokinetics 
Parameters 
The following pharmacokinetic parameters will be analyzed from tear 
fluid samples collected from subjects:  
The pharmacokinetic profile of travoprost and travoprost acid 
concentrations in tear fluid versus time.  
The maximum (Cmax) and minimum (Cmin) concentration of travoprost 
and travoprost acid in tear fluid. 
Calculations will be completed by the PK lab for tear fluid analysis.   
Safety 
Evaluations 
Safety evaluations include: 
- 
Adverse events  
- 
Subject ocular comfort assessment 
- 
Best corrected visual acuity (BCVA) 
- 
Slit lamp biomicroscopy including assessment and grade of ocular 
hyperemia (at slit lamp) and punctum exam 
- 
Intraocular pressure (IOP) 
- 
Fundus examination  
- 
Optical Coherence Tomography of optic nerve on nerve fiber layer 
- 
Automated perimetry 
- 
Number of subjects who need rescue therapy over the study period 
Exploratory 
Evaluations 
- 
Visualization of intracanalicular insert by the Investigator at each 
time point  
- 
Ease of placement of intracanalicular insert 
- 
Number of intracanalicular inserts required in each eye for the study 
period per subject 
Procedural 
Exclusion 
Criteria 
Unsuccessful punctal dilation of either eye (if needed) or punctum of 
either eye is too small to allow transient dilation to 0.7 mm prior for 
insertion of OTX-TP.