ClinicalTrials.gg
RecruitingNCT07495852Updated Mar 30, 2026

Trial to Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant

A Phase 3 interventional study of Gen 2 Travoprost Intracameral Implant and Timolol eye drops 0.5% in Glaucoma, sponsored by Glaukos Corporation. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-30.

Sponsored by Glaukos Corporation · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2026; still recruiting 8 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
510
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Glaucoma

Keywords

  • Open Angle Glaucoma
  • Ocular hypertension
03

In context

Glaucoma

1,419 studies on the registry are indexed under Glaucoma; 223 are open to participants now.

This study's planned enrollment of 510 is above the median of 61 across 964 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Glaukos Corporation is the lead sponsor of 67 studies on the registry; 14 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 7 (54%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of Ocular Hypertension or Open-Angle Glaucoma in the study eye

Exclusion criteria

Exclusion Criteria:

  • Prior incisional glaucoma surgery in the study eye
  • Prior argon laser trabeculoplasty () in the study eye
  • Prior minimally invasive glaucoma (MIGS) surgery in the study eye
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
510 participants (estimated)

Study arms

  • Experimental
    Cohort X Gen 2 Travoprost Intracameral Implant Arm

    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

    Drug: Gen 2 Travoprost Intracameral Implant · Other: placebo eye drops

  • Active comparator
    Cohort X Timolol Arm

    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

    Drug: Timolol eye drops 0.5% · Procedure: Sham Procedure

  • Active comparator
    Cohort Y Gen 2 Travoprost Intracameral Implant Arm

    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

    Drug: Gen 2 Travoprost Intracameral Implant · Other: placebo eye drops

  • Active comparator
    Cohort Y Timolol Arm

    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

    Drug: Timolol eye drops 0.5% · Procedure: Sham Procedure

  • Experimental
    Cohort Z Gen 2 Travoprost Intracameral Implant Arm

    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

    Drug: Gen 2 Travoprost Intracameral Implant · Other: placebo eye drops

  • Active comparator
    Cohort Z Timolol Arm

    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

    Drug: Timolol eye drops 0.5% · Procedure: Sham Procedure

Interventions

  • DrugGen 2 Travoprost Intracameral Implant

    Travoprost

    Also known as: Gen 2 Travoprost Intraocular Implant

  • Timolol 0.5%

    Also known as: Timolol maleate ophthalmic solution, 0.5%

  • ProcedureSham Procedure

    Sham implant administration

  • Otherplacebo eye drops

    Artificial Tears

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • Glaukos Investigative Site
    Dothan, Alabama 36301, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2026 (actual). Primary completion is estimated for Jun 2028, 28 months after the start.

Of 26 industry-sponsored phase 3 interventional studies under Glaucoma, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 26. This study's planned 28 months is above that.

Counting every sponsor, half of 33 studies reached it within 20 months; a quarter within 12 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 23, 2026
First posted
Mar 27, 2026
StartActual
Feb 17, 2026
Primary completionEst.
Jun 2028
CompletionEst.
Mar 2032
Last update
Mar 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07495852
Responsible party
Sponsor
First posted
Mar 27, 2026
Start date
Feb 17, 2026
Primary completion
Jun 2028 (estimated)
Completion
Mar 2032 (estimated)
Last update
Mar 30, 2026

Study contacts

Study Director
Contact
ClinicalResearch@glaukos.com
949-739-8749

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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