Rocklatan vs Latanoprost Post-DSLT | NCT07465913

Studies
Rocklatan vs Latanoprost Post-DSLT

NCT07465913

Sponsor

Eye Centers of Southeast Texas

Status

Recruiting

Last Update Posted

May 22, 2026Actual

Enrollment

36Estimated

Phase

Phase 4

Conditions

Glaucoma

Interventions

Rocklatan 0.02%-0.005% Ophthalmic Solution
Latanoprost 0.005% Ophthalmic Solution

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 14, 2026Actual

Primary Completion Date

May 6, 2027Estimated

Completion Date

May 6, 2027Estimated

First Submitted Date

Mar 6, 2026

First Submission Date that Met QC Criteria

Mar 10, 2026

First Posted Date

Mar 12, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2026

Last Update Posted Date

May 22, 2026Actual

Name	Class
Sengi	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a randomized, double-masked, single-site, prospective, contralateral eye study designed to evaluate the outcomes of Direct Selective Laser Trabeculoplasty (DSLT) followed by the addition of combination netarsudil and latanoprost (Rocklatan) versus latanoprost monotherapy. The study will be conducted at one investigational site. The primary endpoint is the change in mean diurnal intraocular pressure (IOP) from baseline (post DSLT and post washout) at visit 3 between the two groups. Secondary endpoints include the change in mean IOP from baseline at each timepoint (8am, 12pm, 4pm) at visit 3 between groups, and the mean percentage decrease in IOP from baseline for each group. Assessments will be conducted at three key visits: Visit 1 (Screening Phase and DSLT Procedure on Day 0), Visit 2 (Baseline Visit post washout at Week 8), and Visit 3 (Follow-Up Visit 1 at Week 12). Each visit will include specific examinations and measurements such as visual field and OCT imaging, diurnal IOP measurements, and documentation of adverse events.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rocklatan	Experimental	netarsudil and latanoprost 0.02%/0.005%	Drug: Rocklatan 0.02%-0.005% Ophthalmic Solution
Lantanoprost	Active Comparator	0.005%	Drug: Latanoprost 0.005% Ophthalmic Solution

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rocklatan 0.02%-0.005% Ophthalmic Solution	Drug	netarsudil and latanoprost 0.02%/0.005%	Rocklatan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in mean diurnal intraocular pressure (IOP) from baseline		3 months post-treatment initiation

Secondary Outcomes

Measure	Description	Time Frame
Change in mean intraocular pressure (IOP) from baseline at each time of day	8am, 12pm, 4pm	3 months post-treatment initiation
Mean percentage decrease in intraocular pressure (IOP) from baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults (≥18 years) with a diagnosis of mild to moderate bilateral primary open-angle glaucoma (POAG) or open-angle glaucoma (OAG).
On 3 topical glaucoma medications at screening, one of which must be a prostaglandin analog.
Post-DSLT and post-washout, baseline intraocular pressure (IOP) 16-36 mmHg in both eyes.
Best-corrected visual acuity (BCVA) ≥20/60 in both eyes.
Ability and willingness to provide informed consent.

Exclusion Criteria:

Ocular hypertension only (no glaucomatous damage).
Inability or medical ineligibility for washout of ocular hypotensive medications.
Prior selective laser trabeculoplasty (SLT) within 12 months of screening.
History of glaucoma surgery (trabeculectomy, tube shunt, minimally invasive glaucoma surgery [MIGS] affecting outflow).
Narrow or closed angles with gonioscopy (Shaffer grading ≤2).
Active ocular infection, uveitis, or severe dry eye.
Corneal pathology interfering with IOP measurement.
Advanced glaucoma (threat to fixation).
Known hypersensitivity to Rocklatan, latanoprost, or study medication components.
Pregnancy or lactation.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kevin Talbot, MD	Eye Centers of Southeast Texas	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eye Centers of Southeast Texas	Recruiting	Beaumont	Texas	77707	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D005901	Glaucoma

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D000077338	Latanoprost
D009883	Ophthalmic Solutions

Ancestor Terms

ID	Term
D011461	Prostaglandins F, Synthetic
D011465	Prostaglandins, Synthetic
D011453	Prostaglandins
D015777	Eicosanoids

Browse Leaves

Not provided

Browse Branches

Not provided