Open Angle GlaucomaPhase 2NCT05335122

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)

A Phase 2 study testing OTX-TIC low dose Travoprost Intracameral Implant, OTX-TIC high dose Travoprost Intracameral Implant and Durysta, Bimatoprost Intracameral Implant 10 µg in people with Open Angle Glaucoma and Ocular Hypertension, run by Ocular Therapeutix, Inc. at 30 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To assess efficacy, and safety of a single sustained release dose of the OTX-TIC drug product (2 travoprost dose strengths) in subjects with Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT) Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Open Angle Glaucoma, Ocular Hypertension
What is being tested?: OTX-TIC low dose Travoprost Intracameral Implant, OTX-TIC high dose Travoprost Intracameral Implant and Durysta, Bimatoprost Intracameral Implant 10 µg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 83 participants
Where: 30 sitesUnited States
Study dates: 16 Mar 2022to 24 Jan 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Are 18 years of age or older at the time of screening
Provide written informed consent and are able to comply with all study requirements
Are willing to withhold glaucoma medications according to the study requirements, and in the opinion of the investigator can do so without significant risk
Have a negative pregnancy test result for women of childbearing potential at Baseline
Have a documented diagnosis of OHT, or OAG in the study eye

Who cannot join

Have an uncontrolled systemic disease or a debilitating disease (e.g., cardiovascular, hypertension, uncontrolled diabetes)
Are currently pregnant or breast-feeding or of childbearing potential without the use of adequate contraceptive methods during the length of the study
Non-responsive to topical prostaglandins, prostamides or prostaglandin analogs

Trial locations and contacts

30 sites in 1 country.

City, postcode or hospital

30 sites in 1 country

United States30 sites

Ocular Therapeutix, Inc.
Austin, Texas, 78701
Ocular Therapeutix Inc
Carmel, Indiana, 46032
Ocular Therapeutix, Inc.
Clearwater, Florida, 33761
Ocular Therapeutix, Inc.
Cleveland, Ohio, 44106
Ocular Therapeutix, Inc.
Cranberry Township, Pennsylvania, 16066
Ocular Therapeutix, Inc.
Dallas, Texas, 75231
Ocular Therapeutiux, Inc.
Delray Beach, Florida, 33484
Ocular Therapeutix, Inc.
Dothan, Alabama, 36301
Ocular Therapeutix, Inc.
Dover, New Jersey, 07801
Ocular Therapeutix, Inc.
Durham, North Carolina, 27710
Ocular Therapeutix, Inc.
El Paso, Texas, 79902
Ocular Therapeutiux, Inc.
Fargo, North Dakota, 58103
Ocular Therapeutix, Inc.
Fort Myers, Florida, 33901
Ocular Therapeutix, Inc.
Houston, Texas, 77030
Ocular Therapeutix, Inc.
Huntington Beach, California, 92647
Ocular Therapeutix, Inc.
Irvine, California, 92604
Ocular Therapeutix, Inc.
Kenosha, Wisconsin, 53142
Ocular Therapeutix, Inc.
Los Angeles, California, 90013
Ocular Therapeutix Inc
Oklahoma City, Oklahoma, 73112
Ocular Therapeutix, Inc.
Pasadena, California, 91107
Ocular Therapeutix, Inc.
Petaluma, California, 94954
Ocular Therapeutix, Inc.
Philadelphia, Pennsylvania, 19107
Ocular Therapeutix, Inc.
Redlands, California, 92373
Ocular Therapeutix, Inc.
Rock Island, Illinois, 61201
Ocular Therapeutix, Inc.
Roswell, Georgia, 30076
Ocular Therapeutix, Inc.
Saint Joseph, Michigan, 49085
Ocular Therapeutix, Inc.
Saint Joseph, Missouri, 49085
Ocular Therapeutix Inc.
St Louis, Missouri, 63110
Ocular Therapeutix, Inc.
Torrance, California, 90505
Ocular Therapeutix, Inc.
Troy, New York, 12108

Other trials in United States

About this study

Official title: A Prospective, Multi-center, Randomized, Parallel-group, Controlled Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant in Subjects With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT)

To assess efficacy, and safety of a single sustained release dose of the OTX-TIC drug product (2 travoprost dose strengths) in subjects with Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT)

Read the detailed description

This is a prospective, multi-center, randomized, parallel-group, controlled study to evaluate the efficacy, and safety of OTX-TIC (travoprost) intracameral implant in subjects with open angle glaucoma (OAG) or ocular hypertension (OHT). Approximately 105 subjects will be enrolled in this study at approximately 20 sites in the US. Subjects will be a randomized to one of three treatment groups OTX-TIC drug product (2 travoprost dose strengths) compared to a single injection of DurystaTM. Non study eyes will be treated with the PGA, if not contraindicated.

Conditions: Open Angle Glaucoma, Ocular Hypertension
Being tested: OTX-TIC low dose Travoprost Intracameral Implant, OTX-TIC high dose Travoprost Intracameral Implant, Durysta, Bimatoprost Intracameral Implant 10 µg
Medical subject headings: Glaucoma, Open-Angle, Ocular Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OTX-TIC low dose Travoprost Intracameral ImplantDrug
OTX-TIC implant is injected into the anterior chamber of the eye.
OTX-TIC high dose Travoprost Intracameral ImplantDrug
OTX-TIC implant is injected into the anterior chamber of the eye.
Durysta, Bimatoprost Intracameral Implant 10 µgDrug
Durysta is injected into the anterior chamber of the eye.

Study groups in NCT05335122
Study group	Role	What they receive
OTX-TIC Low Dose	Experimental	Travoprost Intracameral Implant low dose Receives: Drug: OTX-TIC low dose Travoprost Intracameral Implant
OTX-TIC High Dose	Experimental	Travoprost Intracameral Implant high dose Receives: Drug: OTX-TIC high dose Travoprost Intracameral Implant
Durysta	Active comparator	Bimatoprost Intracameral Implant 10 µg Receives: Drug: Durysta, Bimatoprost Intracameral Implant 10 µg

What is being measured

The primary outcome is the main question the study is designed to answer.

IOP Changes From Baseline in the Study Eye
IOP changes from baseline 8 AM, 10 AM, and 4 PM at Week 2, Week 6, and Week 12 in the study eye.
Measured: Baseline (8AM, 10 AM, 4 PM) to Week 2 (8 AM, 10 AM, 4 PM) Baseline (8AM, 10 AM, 4 PM) to Week 6 (8 AM, 10 AM, 4 PM) Baseline (8AM, 10 AM, 4 PM) to Week 12 (8 AM, 10 AM, 4 PM)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Mar 202224 Jan 2025

First posted19 Apr 2022
Study start16 Mar 2022
Primary completion24 Jan 2024
Study completion24 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Open Angle GlaucomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Parallel: Participants are assigned to one of three groups in parallel for the duration of the study
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 83 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05335122
Sponsor's protocol ID: OTX-TIC-2020-201
Status last verified: Aug 2026
First submitted: 12 Apr 2022
Last updated: 3 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
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Recruiting
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All Open Angle Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multi-center, Randomized, Parallel-group, Controlled Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant in Subjects With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT)
ClinicalTrials.gov ID: NCT05335122
Acronym / sponsor ID: OTX-TIC-2020-201
Conditions: Open Angle Glaucoma, Ocular Hypertension
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 83 participants (actual)
Lead sponsor: Ocular Therapeutix, Inc.Industry (pharma, biotech, devices)
Study start: 16 Mar 2022 (actual)
Primary completion: 24 Jan 2024 (actual)
Study completion: 24 Jan 2025 (actual)
First posted: 19 Apr 2022 (actual)
Results: Posted 3 Sep 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To assess efficacy, and safety of a single sustained release dose of the OTX-TIC drug product (2 travoprost dose strengths) in subjects with Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT)

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3
Model description: Parallel: Participants are assigned to one of three groups in parallel for the duration of the study

Arm	Type	Receives
OTX-TIC Low Dose	Experimental	Drug: OTX-TIC low dose Travoprost Intracameral ImplantTravoprost Intracameral Implant low dose
OTX-TIC High Dose	Experimental	Drug: OTX-TIC high dose Travoprost Intracameral ImplantTravoprost Intracameral Implant high dose
Durysta	Active comparator	Drug: Durysta, Bimatoprost Intracameral Implant 10 µgBimatoprost Intracameral Implant 10 µg

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Are 18 years of age or older at the time of screening
Provide written informed consent and are able to comply with all study requirements
Are willing to withhold glaucoma medications according to the study requirements, and in the opinion of the investigator can do so without significant risk
Have a negative pregnancy test result for women of childbearing potential at Baseline
Have a documented diagnosis of OHT, or OAG in the study eye

Key exclusion criteria (3 listed)

Have an uncontrolled systemic disease or a debilitating disease (e.g., cardiovascular, hypertension, uncontrolled diabetes)
Are currently pregnant or breast-feeding or of childbearing potential without the use of adequate contraceptive methods during the length of the study
Non-responsive to topical prostaglandins, prostamides or prostaglandin analogs

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OTX-TIC low dose Travoprost Intracameral ImplantOTX-TIC implant is injected into the anterior chamber of the eye.	Drug	OTX-TIC Low Dose
OTX-TIC high dose Travoprost Intracameral ImplantOTX-TIC implant is injected into the anterior chamber of the eye.	Drug	OTX-TIC High Dose
Durysta, Bimatoprost Intracameral Implant 10 µgDurysta is injected into the anterior chamber of the eye.	Drug	Durysta

Primary outcome

IOP Changes From Baseline in the Study Eye
Time frame: Baseline (8AM, 10 AM, 4 PM) to Week 2 (8 AM, 10 AM, 4 PM) Baseline (8AM, 10 AM, 4 PM) to Week 6 (8 AM, 10 AM, 4 PM) Baseline (8AM, 10 AM, 4 PM) to Week 12 (8 AM, 10 AM, 4 PM)
IOP changes from baseline 8 AM, 10 AM, and 4 PM at Week 2, Week 6, and Week 12 in the study eye.

Results and safety

Results posted to the registry on 3 Sep 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OTX-TIC 5 µg	16	16
OTX-TIC 26 µg	32	30
Durysta	34	32

Primary outcome: IOP Changes From Baseline in the Study Eye

Time frame: Baseline (8AM, 10 AM, 4 PM) to Week 2 (8 AM, 10 AM, 4 PM) Baseline (8AM, 10 AM, 4 PM) to Week 6 (8 AM, 10 AM, 4 PM) Baseline (8AM, 10 AM, 4 PM) to Week 12 (8 AM, 10 AM, 4 PM). Mean (Standard Deviation). Unit: Millimeter of Mercury (mmHg)

Measure	OTX-TIC 5 µg n = 16	OTX-TIC 26 µg n = 32	Durysta n = 34
Change from Baseline (8 AM) to Week 2 (8 AM)	-7.69 (3.807)	-7.66 (4.243)	-7.03 (3.567)
Change from Baseline (10 AM) to Week 2 (10 AM)	-6.37 (3.287)	-7.34 (4.786)	-6.21 (3.162)
Change from Baseline (4 PM) to Week 2 (4 PM)	-5.47 (3.507)	-6.23 (4.291)	-6.19 (3.071)
Change from Baseline (8 AM) to Week 6 (8 AM)	-7.81 (3.130)	-7.70 (3.692)	-7.09 (3.762)
Change from Baseline (10 AM) to Week 6 (10 AM)	-6.40 (3.318)	-7.00 (4.049)	-5.97 (3.665)
Change from Baseline (4 PM) to Week 6 (4 PM)	-5.53 (2.682)	-5.81 (3.823)	-5.87 (3.391)
Change from Baseline (8 AM) to Week 12 (8 AM)	0.68 (13.476)	-7.03 (3.610)	-6.13 (3.799)
Change from Baseline (10 AM) to Week 12 (10 AM)	-1.38 (9.366)	-6.12 (3.729)	-5.58 (3.170)

Population analysed: The analysis was performed on the mITT population according to the treatment received. The mITT population included all subjects who received an investigational product (OTX-TIC or Durysta) in the study eye \[SE\]. The SE is defined as the eye that meets the entry criteria. If both eyes qualify for study entry the SE will be selected on the basis of the eye with the highest IOP at baseline. Data collected after the receipt of IOP lowering medication (rescue therapy) will be treated as missing.

Adverse events

Time frame: From time of administration of study drug to last visit (up to 12 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OTX-TIC 5 µg	1 of 16 (6.3%)	12 of 16 (75%)	0 of 16
OTX-TIC 26 µg	6 of 32 (18.8%)	20 of 32 (62.5%)	0 of 32
Durysta	4 of 34 (11.8%)	8 of 34 (23.5%)	0 of 34

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

30 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

IOP Changes From Baseline in the Study Eye (time frame: Baseline (8AM, 10 AM, 4 PM) to Week 2 (8 AM, 10 AM, 4 PM) Baseline (8AM, 10 AM, 4 PM) to Week 6 (8 AM, 10 AM, 4 PM) Baseline (8AM, 10 AM, 4 PM) to Week 12 (8 AM, 10 AM, 4 PM)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05335122.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.