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RecruitingNCT07847073Updated Sep 29, 2026

Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients

A Phase 4 interventional study of Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA] and Timolol Maleate 0.25% Ophthalmic Solution in Open Angle Glaucoma (OAG) and Glaucoma, sponsored by Brett King. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Brett King · Phase 4, Interventional, and Other

Phase
Phase 4
Study type
Interventional
Enrollment
13
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to compare how two FDA-approved eye drops: netarsudil (Rhopressa) and timolol, protect nerve cells in the eye of adults with open-angle glaucoma. Both medications lower pressure inside the eye, but researchers want to learn if Rhopressa is more effective at slowing down or preventing the loss of retinal ganglion cells. These cells are essential for sight because they carry visual signals from the eye to the brain.

Participants in this study will complete a total of 6 study visits over 12 months:

  • Participants will spend 6 months using Rhopressa eye drops and 6 months using Timolol eye drops. The order of the two eye drops will be chosen randomly.
  • At scheduled study visits, researchers will examine participants' eyes and measure eye pressure.
  • Researchers will take detailed pictures of the back of the eye using a specialized high-resolution camera called adaptive optics optical coherence tomography (AO-OCT).
  • Participants will also complete specialized visual field testing to measure eye function.

Researchers will count and track individual nerve cells over time to determine if one medication offers better protection against cell loss than the other.

Read the detailed description

Glaucoma is a chronic, progressive optic neuropathy characterized by functional and structural alterations, specifically the degeneration and loss of retinal ganglion cells (RGCs). Currently, the main modifiable factor for intervention is aimed at lowering intraocular pressure (IOP). While IOP reduction slows disease progression, it does not halt neurodegeneration. Rho kinase (ROCK) inhibitors have been reported to provide benefit in neurodegenerative diseases. Netarsudil ophthalmic solution (Rhopressa) is a ROCK inhibitor approved for the treatment and management of open-angle glaucoma that lowers IOP and has reported protective effects on neural tissue. However, previous attempts to illustrate true cell loss or protection using clinical instrumentation have not demonstrated an effect to date.

High-resolution retinal imaging based on adaptive optics optical coherence tomography (AO-OCT) enables direct visualization, tracking, and quantification of individual ganglion cell layer (GCL) somas in the living human eye. Leveraging the unique imaging capabilities and extraordinary sensitivity of ultra-high-speed AO-OCT, this study will test the hypothesis that treatment with netarsudil is more effective at reducing glaucomatous ganglion cell loss while producing comparable intraocular pressure reduction to that of the comparator.

This prospective, randomized, investigator-masked, cross-over pilot study will compare RGC survival rates between two treatment groups (Rhopressa and Timolol). Thirteen subjects with open-angle glaucoma will be recruited. Following a screening assessment and medication washout period based on drug class, eligible subjects are randomized 1:1 into two age-matched cohorts:

  • Cohort 1: Receives Rhopressa (one drop once at night) for 6 months, then crosses over to receive Timolol 0.25% (one drop twice a day) for 6 months.
  • Cohort 2: Receives Timolol 0.25% (one drop twice a day) for 6 months, then crosses over to receive Rhopressa (one drop once at night) for 6 months.

At Visit 2 (baseline), Visit 4 (6 months), and Visit 6 (12 months), subjects undergo imaging using the Indiana AO-OCT system along with Goldmann applanation tonometry, standard clinical OCT, and OCT-guided microperimetry (MP-3). AO-OCT imaging is performed at the same retinal regions surrounding arcuate defects to enable longitudinal cellular-level analysis. Primary and secondary endpoints evaluate differences in the rate of change of RGC soma density, individual RGC counts, and GCL thickness between treatment periods.

02

Conditions studied

  • Open Angle Glaucoma (OAG)
  • Glaucoma

Keywords

  • glaucoma
  • rhopressa
  • ganglion cells
  • optometry
  • vision
  • IOP
  • eye pressure
  • timolol
03

Who can participate

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

Inclusion criteria

  • All subjects will be 18 years of age or older
  • Subjects must be diagnosed with open-angle glaucoma and have had an eye exam within the past year
  • Subjects with glaucoma will have structural (optic nerve and retinal nerve fiber layer) and functional (visual field testing) defects consistent with the diagnosis of glaucoma
  • Subjects will have a corrected acuity of 20/50 or better and be able to fixate
  • Naïve to medication subjects or post washout IOP between 18 and 34 mmHg
  • Spherical equivalent from +3 diopters to -6 diopters, with a cylinder of \<-3 diopters
  • Subject is willing and able to comply with the protocol requirements and to remain in the study for its full duration, including all scheduled visits and follow-up assessments

Exclusion criteria

Exclusion Criteria:

  • Subjects with a known intolerance to netarsudil ophthalmic solution
  • Subjects with a known intolerance to, or contraindication for, timolol maleate
  • Any subject whom the investigator determines to be at unacceptable risk for the washout or believes is unlikely to complete the study
  • Subjects with retinal disease or optic neuropathies other than glaucoma that, in the opinion of the investigator, could confound the study assessments or outcome
  • Female subjects who are pregnant, breastfeeding, or of childbearing age who are not sterile or using an acceptable method of contraception during the study
04

Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
13 participants (estimated)

Study arms

  • Experimental
    Rhopressa first, then Timolol

    Participants will instill netarsudil 0.02% (Rhopressa) ophthalmic solution (1 drop in the study eye once daily in the evening) for the first 6 months (Months 0-6). At the Month 6 visit, participants will cross over to instill timolol maleate 0.25% ophthalmic solution (1 drop in the study eye twice daily) for the remaining 6 months (Months 6-12).

    Drug: Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA] · Drug: Timolol Maleate 0.25% Ophthalmic Solution

  • Experimental
    Timolol first, then Rhopressa

    Participants will instill timolol maleate 0.25% ophthalmic solution (1 drop in the study eye twice daily) for the first 6 months (Months 0-6). At the Month 6 visit, participants will cross over to instill netarsudil 0.02% (Rhopressa) ophthalmic solution (1 drop in the study eye once daily in the evening) for the remaining 6 months (Months 6-12).

    Drug: Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA] · Drug: Timolol Maleate 0.25% Ophthalmic Solution

Interventions

  • DrugNetarsudil 0.02% Ophthalmic Solution [RHOPRESSA]

    Netarsudil ophthalmic solution (Rhopressa) is an FDA-approved Rho kinase inhibitor indicated for the treatment of ocular hypertension and open-angle glaucoma. In this study, participants will instill 1 drop of netarsudil 0.02% ophthalmic solution in the study eye once daily in the evening for 6 months.

    Also known as: Rhopressa

  • DrugTimolol Maleate 0.25% Ophthalmic Solution

    Timolol maleate ophthalmic solution is an FDA-approved non-selective beta-adrenergic receptor blocking agent indicated for the treatment of ocular hypertension and open-angle glaucoma. In this study, participants will instill 1 drop of timolol maleate 0.25% ophthalmic solution in the study eye twice daily (in the morning and evening) for 6 months.

    Also known as: Timoptic

05

What researchers measure

Primary outcomes

  1. Change in GC soma density (cells/mm²)

    Change in ganglion cell (GC) soma density during treatment with timolol versus netarsudil (Rhopressa)

    Time frame: Baseline, 6 months, and 12 months

Secondary outcomes

  1. Changes in GC soma counts (number of cells)

    Changes in ganglion cell (GC) soma counts during treatment with timolol versus netarsudil (Rhopressa)

    Time frame: Baseline, 6 months, and 12 months

  2. Changes in GCL thickness (micrometers (µm))

    Changes in ganglion cell layer (GCL) thickness during treatment with timolol versus netarsudil (Rhopressa)

    Time frame: Baseline, 6 months, and 12 months

06

Study locations

1 of 1 sites recruiting
  • Indiana University School Of Optometry
    Bloomington, Indiana 47405, United States
    • Brett J King, OD, FAAO, Dipl AAO(Glaucoma) · Contact · kingbrj@iu.edu · (812) 855-1344
    • Kaitlyn M Asher, CCRC, BS · Contact · kamasher@iu.edu · 2194067487
    • Donald T Miller, PhD · Sub investigator
    • Matthew Keller, OD · Sub investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT07847073
Lead sponsor
Brett King
Collaborators
Alcon Research
Responsible party
Brett King (Clinical Professor, Indiana University) — Sponsor-investigator
First posted
Sep 29, 2026
Start date
Oct 2026 (estimated)
Primary completion
Jan 2028 (estimated)
Completion
Jan 2028 (estimated)
Last update
Sep 29, 2026

Study contacts

Brett J King, OD, FAAO, Dipl AAO (Glaucoma)
Contact
kingbrj@iu.edu
(812) 855-1344
Kaitlyn M Asher, CCRC, BS
Contact
kamasher@iu.edu
2194067487

Oversight

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

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