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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
Must not have
Non-responsive to topical prostaglandins, prostamides or prostaglandin analogs
Have an uncontrolled systemic disease or a debilitating disease (e.g., cardiovascular, hypertension, uncontrolled diabetes)
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
Summary
This trial tests a small device that releases medication inside the eye to help patients with high eye pressure due to glaucoma or ocular hypertension. The medication helps fluid drain from the eye, reducing pressure and preventing vision problems.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
Eye drops for my condition did not work for me.
Select...
I do not have any uncontrolled illnesses like heart disease or diabetes.
Select...
I am not pregnant, breastfeeding, and if I can have children, I use birth control.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Ocular Hypertension aim to reduce intraocular pressure (IOP) by enhancing the outflow of aqueous humor or decreasing its production. Prostaglandin analogs like Travoprost, which is being studied in the OTX-TIC trial, increase the outflow of aqueous humor through the uveoscleral pathway, thereby lowering IOP.
Beta-blockers, such as timolol, reduce the production of aqueous humor by inhibiting beta-adrenergic receptors in the ciliary body. Carbonic anhydrase inhibitors decrease aqueous humor production by inhibiting the enzyme carbonic anhydrase.
These mechanisms are crucial for OHT patients as sustained high IOP can lead to optic nerve damage and glaucoma, potentially resulting in vision loss. Effective management of IOP helps to prevent these complications and preserve vision.
[Quantitative evaluation of uveoscleral outflow for optimization of glaucoma treatment].Latanoprostene bunod ophthalmic solution 0.024% for IOP lowering in glaucoma and ocular hypertension.Travoprost/timolol fixed combination in the management of open-angle glaucoma: a clinical review.
[Quantitative evaluation of uveoscleral outflow for optimization of glaucoma treatment].Latanoprostene bunod ophthalmic solution 0.024% for IOP lowering in glaucoma and ocular hypertension.Travoprost/timolol fixed combination in the management of open-angle glaucoma: a clinical review.
Find a Location
Who is running the clinical trial?
Ocular Therapeutix, Inc.Lead Sponsor
54 Previous Clinical Trials
6,297 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:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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
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