GlaucomaPhase 3NCT07495852
Trial to Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant
A Phase 3 study testing Gen 2 Travoprost Intracameral Implant and Timolol eye drops 0.5% in people with Glaucoma, run by Glaukos Corporation at 1 site in United States.
Trial summary
Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Gen 2 Travoprost Intracameral Implant and Timolol eye drops 0.5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 510 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2026to Mar 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Diagnosis of Ocular Hypertension or Open-Angle Glaucoma in the study eye
Who cannot join
- Prior incisional glaucoma surgery in the study eye
- Prior argon laser trabeculoplasty (ALT) in the study eye
- Prior minimally invasive glaucoma (MIGS) surgery in the study eye
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Glaukos Investigative Site
Dothan, Alabama, 36301
Luis Vargas, MD, 949-739-8749, ClinicalResearch@glaukos.com
About this study
Official title: Phase 3 Trial to Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant
Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant
Read the detailed description
Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant Compared to Timolol Ophthalmic Solution 0.5% Administered Twice Daily in Subjects with Open-Angle Glaucoma or Ocular Hypertension
- Conditions
- Glaucoma
- Being tested
- Gen 2 Travoprost Intracameral Implant, Timolol eye drops 0.5%, Sham Procedure, placebo eye drops
- Keywords
- Open Angle Glaucoma, Ocular hypertension
- Medical subject headings
- Glaucoma, Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gen 2 Travoprost Intracameral ImplantDrug
Also called Gen 2 Travoprost Intraocular Implant
Travoprost
Timolol eye drops 0.5%Drug
Also called Timolol maleate ophthalmic solution, 0.5%
Timolol 0.5%
Sham ProcedureProcedure or surgery
Sham implant administration
placebo eye dropsOther
Artificial Tears
| Study group | Role | What they receive |
|---|---|---|
| Cohort X Gen 2 Travoprost Intracameral Implant Arm | Experimental | Randomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and undergo an exchange procedure at month 12 and be followed for an additional 12 months Receives: Drug: Gen 2 Travoprost Intracameral Implant; Other: placebo eye drops |
| Cohort X Timolol Arm | Active comparator | Randomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will administer timolol 0.5% eye drops BID (plus sham procedure) in the study eye and undergo a sham exchange procedure at month 12 and be followed for an additional 12 months Receives: Drug: Timolol eye drops 0.5%; Procedure: Sham Procedure |
| Cohort Y Gen 2 Travoprost Intracameral Implant Arm | Active comparator | Randomized, double-masked, active-controlled, Phase 3 portion of the trial, subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and undergo an exchange procedure at month 24 and be followed for an additional 12 months Receives: Drug: Gen 2 Travoprost Intracameral Implant; Other: placebo eye drops |
| Cohort Y Timolol Arm | Active comparator | Randomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will receive timolol 0.5% eye drops BID (plus sham procedure) in the study eye and undergo a sham exchange procedure at month 24 and be followed for an additional 12 months Receives: Drug: Timolol eye drops 0.5%; Procedure: Sham Procedure |
| Cohort Z Gen 2 Travoprost Intracameral Implant Arm | Experimental | Randomized, double-masked, active-controlled, Phase 3 portion of the trial, subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and undergo an exchange procedure at month 36 and be followed for an additional 12 months Receives: Drug: Gen 2 Travoprost Intracameral Implant; Other: placebo eye drops |
| Cohort Z Timolol Arm | Active comparator | Randomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will administer timolol 0.5% eye drops BID (plus sham procedure) in the study eye and undergo an sham exchange procedure at month 36 and be followed for an additional 12 months Receives: Drug: Timolol eye drops 0.5%; Procedure: Sham Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure (IOP)
Change from baseline in diurnal IOP in the study eye at 8am and 10am at each of Day 11, Week 6, and Month 3 visits
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start17 Feb 2026
- Primary completionJun 2028 (estimated)
- Study completionMar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Glaukos CorporationThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized to undergo initial implant of an intracameral implant and prescription of artificial tears or a sham procedure and prescription of timolol. Subjects will be assessed for eligibility for an exchange procedure at 12, 24 or 36 months and followed for an additional 12 months
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 510 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glaukos Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495852
- Sponsor's protocol ID
- GLK-102-02
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Trial to Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant
- ClinicalTrials.gov ID
- NCT07495852
- Acronym / sponsor ID
- GLK-102-02
- Conditions
- Glaucoma
- Keywords
- Open Angle Glaucoma, Ocular hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 510 participants (estimated)
- Lead sponsor
- Glaukos CorporationIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Mar 2032 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant
Detailed description
Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant Compared to Timolol Ophthalmic Solution 0.5% Administered Twice Daily in Subjects with Open-Angle Glaucoma or Ocular Hypertension
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Subjects will be randomized to undergo initial implant of an intracameral implant and prescription of artificial tears or a sham procedure and prescription of timolol. Subjects will be assessed for eligibility for an exchange procedure at 12, 24 or 36 months and followed for an additional 12 months
| Arm | Type | Receives |
|---|---|---|
| Cohort X Gen 2 Travoprost Intracameral Implant Arm | Experimental | Drug: Gen 2 Travoprost Intracameral Implant, Other: placebo eye dropsRandomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and undergo an exchange procedure at month 12 and be followed for an additional 12 months |
| Cohort X Timolol Arm | Active comparator | Drug: Timolol eye drops 0.5%, Procedure: Sham ProcedureRandomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will administer timolol 0.5% eye drops BID (plus sham procedure) in the study eye and undergo a sham exchange procedure at month 12 and be followed for an additional 12 months |
| Cohort Y Gen 2 Travoprost Intracameral Implant Arm | Active comparator | Drug: Gen 2 Travoprost Intracameral Implant, Other: placebo eye dropsRandomized, double-masked, active-controlled, Phase 3 portion of the trial, subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and undergo an exchange procedure at month 24 and be followed for an additional 12 months |
| Cohort Y Timolol Arm | Active comparator | Drug: Timolol eye drops 0.5%, Procedure: Sham ProcedureRandomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will receive timolol 0.5% eye drops BID (plus sham procedure) in the study eye and undergo a sham exchange procedure at month 24 and be followed for an additional 12 months |
| Cohort Z Gen 2 Travoprost Intracameral Implant Arm | Experimental | Drug: Gen 2 Travoprost Intracameral Implant, Other: placebo eye dropsRandomized, double-masked, active-controlled, Phase 3 portion of the trial, subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and undergo an exchange procedure at month 36 and be followed for an additional 12 months |
| Cohort Z Timolol Arm | Active comparator | Drug: Timolol eye drops 0.5%, Procedure: Sham ProcedureRandomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will administer timolol 0.5% eye drops BID (plus sham procedure) in the study eye and undergo an sham exchange procedure at month 36 and be followed for an additional 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of Ocular Hypertension or Open-Angle Glaucoma in the study eye
Key exclusion criteria (3 listed)
- Prior incisional glaucoma surgery in the study eye
- Prior argon laser trabeculoplasty (ALT) in the study eye
- Prior minimally invasive glaucoma (MIGS) surgery in the study eye
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 |
|---|---|---|
| Gen 2 Travoprost Intracameral ImplantAlso: Gen 2 Travoprost Intraocular ImplantTravoprost | Drug | Cohort X Gen 2 Travoprost Intracameral Implant Arm, Cohort Y Gen 2 Travoprost Intracameral Implant Arm, Cohort Z Gen 2 Travoprost Intracameral Implant Arm |
| Timolol eye drops 0.5%Also: Timolol maleate ophthalmic solution, 0.5%Timolol 0.5% | Drug | Cohort X Timolol Arm, Cohort Y Timolol Arm, Cohort Z Timolol Arm |
| Sham ProcedureSham implant administration | Procedure or surgery | Cohort X Timolol Arm, Cohort Y Timolol Arm, Cohort Z Timolol Arm |
| placebo eye dropsArtificial Tears | Other | Cohort X Gen 2 Travoprost Intracameral Implant Arm, Cohort Y Gen 2 Travoprost Intracameral Implant Arm, Cohort Z Gen 2 Travoprost Intracameral Implant Arm |
Primary outcome
Intraocular pressure (IOP)
Time frame: 3 months
Change from baseline in diurnal IOP in the study eye at 8am and 10am at each of Day 11, Week 6, and Month 3 visits
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Glaucoma
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
Glaucoma
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
RecruitingPhase 2
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.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gen 2 Travoprost Intracameral Implant and Timolol eye drops 0.5% in people with Glaucoma, run by Glaukos Corporation at 1 site in United States.
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 1 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: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Director (949-739-8749, ClinicalResearch@glaukos.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure (IOP) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2026.