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Prostaglandin Analog
Travoprost Implant for Glaucoma
Phase 2
Waitlist Available
Research Sponsored by Ocular Therapeutix, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Are 18 years of age or older at the time of screening
Have a documented diagnosis of OHT, or OAG in the study eye
Timeline
Screening 3 weeks
Treatment Varies
Follow Up diurnal iop [time frame: diurnal iop at the 2 week visit] diurnal iop [time frame: diurnal iop at the 6 week visit] diurnal iop [time frame: diurnal iop at the 12 week visit]
Awards & highlights
Study Summary
This trial will look at the effectiveness and safety of a new drug for people with open angle glaucoma or ocular hypertension.
Who is the study for?
This trial is for adults with Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT). Participants must be willing to stop their glaucoma medications as per study rules and not be at risk by doing so. Pregnant or breastfeeding individuals, those unresponsive to certain eye pressure-lowering drugs, or with uncontrolled diseases like severe diabetes are excluded.Check my eligibility
What is being tested?
The trial tests two doses of OTX-TIC Travoprost Intracameral Implant against a known treatment, Durysta Bimatoprost Implant. It aims to see how well these treatments lower eye pressure in patients with OAG or OHT over time and monitor safety.See study design
What are the potential side effects?
Possible side effects may include redness, discomfort in the eyes, changes in vision, eye irritation or pain. There could also be risks associated with the implant procedure itself such as bleeding inside the eye.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have been diagnosed with high eye pressure or open-angle glaucoma in one eye.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ diurnal iop [time frame: diurnal iop at the 2 week visit] diurnal iop [time frame: diurnal iop at the 6 week visit] diurnal iop [time frame: diurnal iop at the 12 week visit]
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~diurnal iop [time frame: diurnal iop at the 2 week visit] diurnal iop [time frame: diurnal iop at the 6 week visit] diurnal iop [time frame: diurnal iop at the 12 week visit]
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy Outcome: IOP changes from Baseline
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: OTX-TIC Low DoseExperimental Treatment1 Intervention
Travoprost Intracameral Implant low dose
Group II: OTX-TIC High DoseExperimental Treatment1 Intervention
Travoprost Intracameral Implant high dose
Group III: DurystaActive Control1 Intervention
Bimatoprost Intracameral Implant 10 µg
Find a Location
Who is running the clinical trial?
Ocular Therapeutix, Inc.Lead Sponsor
53 Previous Clinical Trials
5,472 Total Patients Enrolled
4 Trials studying Ocular Hypertension
696 Patients Enrolled for Ocular Hypertension
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.Women who could become pregnant must have a negative pregnancy test before starting the study.I have been diagnosed with high eye pressure or open-angle glaucoma in one eye.Eye drops for my condition did not work for me.I do not have any uncontrolled illnesses like heart disease or diabetes.I am not pregnant, breastfeeding, and if I can have children, I use birth control.
Research Study Groups:
This trial has the following groups:- Group 1: OTX-TIC Low Dose
- Group 2: OTX-TIC High Dose
- Group 3: Durysta
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Ocular Hypertension Patient Testimony for trial: Trial Name: NCT05335122 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are research subjects still being recruited for this trial?
"That is correct. The online clinical trials database has the latest information on this trial, which as of 4/12/2022 was actively recruiting 105 patients from 9 different centres."
Answered by AI
How many individuals are currently enrolled in this clinical trial?
"To successfully carry out this research, a total of one-hundred and five participants that meet the pre-specified inclusion criteria are required. The sponsor, Ocular Therapeutix, Inc., will be conducting the trial at multiple locations including Ocular Therapeutiux, Inc. in Delray Beach, Florida and Ocular Therapeutix Inc in Carmel, Indiana."
Answered by AI
Has the FDA given the okay to OTX-TIC high dose Travoprost Intracameral Implant?
"Our company Power has given OTX-TIC high dose Travoprost Intracameral Implant a safety score of 2. This is due to the lack of efficacy data, as this medication is still in Phase 2 clinical trials."
Answered by AI
In how many different medical clinics is this clinical trial being performed?
"This trial is accepting patients at Ocular Therapeutiux, Inc. in Delray Beach, Florida; Ocular Therapeutix Inc in Carmel, Indiana; and Ocular Therapeutix Inc. in Oklahoma City, Oklahoma along with 9 other locations."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
Ocular Therapeutix, Inc.
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I want to see what can help me as an glaucoma suspect.
PatientReceived 1 prior treatment
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