Travoprost Implant for Glaucoma

No longer recruiting at 29 trial locations

Overseen By Clinical Project Manager

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Ocular Therapeutix, Inc.

Must not be taking: Topical prostaglandins

Disqualifiers: Uncontrolled systemic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for individuals with Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT), conditions that can cause vision problems if not managed. Researchers aim to evaluate the effectiveness and safety of different doses of a travoprost implant (a type of eye implant) compared to an existing treatment called Durysta. Participants will receive either a high dose or low dose of the travoprost implant or the Durysta implant. Those diagnosed with OAG or OHT who can manage without their current glaucoma medications might be suitable for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in eye care.

Do I need to stop my current medications for the trial?

Yes, you will need to stop taking your current glaucoma medications as part of the study requirements, but only if the investigator believes it can be done safely.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the OTX-TIC Travoprost Intracameral Implant is generally well-tolerated. In a study involving patients with open-angle glaucoma or high eye pressure, most implants were mostly or completely absorbed within six months. Researchers closely monitored any side effects that appeared after treatment began, and no serious problems emerged.

Similarly, Durysta, the Bimatoprost Intracameral Implant, has already received approval for other eye conditions, indicating it has passed strict safety checks by the FDA.

While any treatment can have side effects, evidence so far suggests that both the OTX-TIC and Durysta implants are safe options for managing certain eye conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard eye drops used for treating glaucoma, the Travoprost Intracameral Implant (OTX-TIC) offers a unique delivery method, being implanted directly into the eye. This potentially allows for a sustained release of medication, which can improve patient adherence by reducing the need for daily eye drops. Researchers are particularly excited about the OTX-TIC's ability to deliver a targeted dose over a longer period, which could enhance effectiveness and reduce side effects compared to traditional treatments. Additionally, the implant comes in both high and low doses, providing flexibility in treatment options to better suit individual patient needs.

What evidence suggests that this trial's treatments could be effective for Open Angle Glaucoma or Ocular Hypertension?

Studies have shown that the travoprost intracameral implant, known as OTX-TIC, effectively lowers eye pressure in individuals with open-angle glaucoma (OAG) and ocular hypertension (OHT). In this trial, participants will receive either a high dose or a low dose of the OTX-TIC implant. Research indicates that these implants reduce eye pressure as well as, or even better than, the commonly used travoprost eye drops. The implants release medication slowly over time, offering a more convenient and consistent alternative to daily eye drops. This method may also avoid issues associated with eye drops, such as irritation or the hassle of daily application. Initial findings suggest that both high and low doses of OTX-TIC show promise for managing eye pressure in these conditions. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Women who could become pregnant must have a negative pregnancy test before starting the study.

Are willing to withhold glaucoma medications according to the study requirements, and in the opinion of the investigator can do so without significant risk

I have been diagnosed with high eye pressure or open-angle glaucoma in one eye.

Exclusion Criteria

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single sustained release dose of the OTX-TIC drug product (2 travoprost dose strengths) or a single injection of DurystaTM

12 weeks

Visits at Week 2, Week 6, and Week 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Durysta, Bimatoprost Intracameral Implant 10 µg
• OTX-TIC high dose Travoprost Intracameral Implant
• OTX-TIC low dose Travoprost Intracameral Implant

Trial Overview 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.

How Is the Trial Designed?

Group I: OTX-TIC Low Dose Experimental Treatment 1 Intervention

Travoprost Intracameral Implant low dose

Group II: OTX-TIC High Dose Experimental Treatment 1 Intervention

Travoprost Intracameral Implant high dose

Group III: Durysta Active Control 1 Intervention

Bimatoprost Intracameral Implant 10 µg

Who Is Running the Clinical Trial?

Ocular Therapeutix, Inc.

Lead Sponsor

Trials

55

Recruited

6,400+

Published Research Related to This Trial

The bimatoprost implant (Durysta™) is a biodegradable drug delivery system that provides sustained release of bimatoprost to lower intraocular pressure (IOP) for 4 to 6 months, making it a convenient treatment option for patients with open angle glaucoma or ocular hypertension.

Approved in March 2020, the implant represents a significant advancement in glaucoma treatment, allowing for prolonged IOP control without the need for daily eye drops, and its clinical development is still ongoing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bimatoprost Implant: First Approval. Shirley, M.[2020]

In a study of 122 eyes from 84 patients, bimatoprost sustained-release (SR) significantly reduced intraocular pressure (IOP) from 18.5 mmHg to 16.0 mmHg and decreased the number of required glaucoma medications from 2.1 to 1.2, indicating its efficacy in managing glaucoma.

Among 41 eyes from 31 patients with prior glaucoma surgeries, bimatoprost SR also reduced medication burden, showing a decrease from 1.9 to 1.0 medications, suggesting it is effective even for patients who have undergone previous surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of bimatoprost sustained-release intracameral implant on intraocular pressure and medication burden in patients with prior glaucoma surgery. Bowers, ME., Wong, MK., Ventimiglia, J., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05335122?term=AREA%5BBasicSearch%5D(DURYSTA)&rank=4

A Study to Evaluate the Efficacy and Safety of OTX-TIC ... A Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant for Patients With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT).

2. ocutx.com ocutx.com/pipeline/otx-tic/

OTX-TIC OTX-TIC (travoprost intracameral hydrogel) is an investigational injectable product which is intended to have an extended duration of action aiming for long- ...

3. reviewofophthalmology.com reviewofophthalmology.com/article/a-medical-therapy-update

A Medical Therapy Update A study to evaluate the efficacy and safety of OTX-TIC (travoprost) intracameral implant for patients with open-angle glaucoma (OAG) or ocular ...

4. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/10600280241291911

Travoprost Intracameral Implant: A Review on the Novel ... Travoprost implants showed significant reductions in IOP compared with other treatment options with fewer limitations often associated with topical medications ...

5. ophthalmologytimes.com ophthalmologytimes.com/view/travoprost-intracameral-implant-shows-efficacy-in-topical-form

Travoprost intracameral implant shows efficacy in topical form One travoprost intracameral implant (OTX-TIC, Ocular Therapeutix) was as effective as the topical form of the drug in lowering IOP.

6. investors.ocutx.com investors.ocutx.com/static-files/7d4551c6-1158-4a4b-a13a-2198a210de00

Travoprost Intracameral Implant (OTX-TIC) for Open-angle ... Microparticles may still be seen. • Majority (64.5%) of PAXTRAVA 26 µg implants were significantly or fully bioresorbed by. Month 6. • Over 90% ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38345710/

Travoprost Intracameral Implant for Open-Angle Glaucoma ... Safety outcomes included treatment-emergent adverse events (TEAEs) and ophthalmic assessments. Results: A total of 590 patients were ...