What side effects are associated with this type of intervention?

Common treatments for ocular hypertension, such as prostaglandin analogs (including Travoprost), primarily work by increasing the outflow of aqueous humor to reduce intraocular pressure. Known side effects of these medications can include eye redness, eyelash growth, changes in iris color, eye discomfort, and potential systemic effects like headache. Other treatments, such as beta-blockers, carbonic anhydrase inhibitors, and alpha agonists, may also be used and can have side effects like fatigue, dry mouth, and altered taste. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for Ocular Hypertension that work by increasing aqueous humor outflow to reduce intraocular pressure. These include prostaglandin analogs such as latanoprost, bimatoprost, and tafluprost, which are similar to travoprost being studied in the OTX-TIC trial. These medications are commonly used due to their efficacy in lowering IOP and their relatively favorable safety profiles.

What other types of research exist?

Promising alternatives to OTX-TIC (Travoprost) for Ocular Hypertension patients include Selective Laser Trabeculoplasty (SLT) and new pharmacologic agents like Varenicline nasal spray. SLT has shown comparable efficacy to medical therapy with fewer adverse events and better IOP stability. Varenicline nasal spray, although primarily for dry eye disease, represents a novel approach that may have potential applications in ocular hypertension due to its mechanism of action on tear production and ocular surface health.

← Back to Search

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

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

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 below

Select...

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]

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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] for reporting.

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

Awards & Highlights

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.

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

0 / 5Eligibility criteria met

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.