Health TrialsbyHealthPanel

Rocklatan Adds Pressure Reduction After MIGS (Minimally Invasive Glaucoma Surgery)

ConditionPrimary Open Angle Glaucoma
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40+
SponsorCenter for Sight Las Vegas

About this trial

The primary objective of this study is to determine if the addition of Rocklatan post-Hydrus will provide additional intraocular pressure lowering.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 40 years and older

Subjects who have mild to moderate Open Angle Glaucoma (OAG)

Subjects who have undergone uncomplicated cataract surgery and Hydrus microstent implantation > 3 months prior to screening and within the last 2 years

Post-Hydrus subjects on 0-2 ocular hypotensive medication classes who can safely washout (if on ocular hypotensive medications)

Disqualifiers

History of intraocular surgery except for uneventful refractive surgery or uncomplicated cataract surgery and hydrus microstent implantation

Prior Selective Laser Trabeculoplasty (SLT) within 18 months of surgery

Secondary glaucoma excluding pseudoexfoliation and pigmentary dispersion syndrome

Severe Open Angle Glaucoma

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rocklatan (netarsudil 0.02% and latanoprost 0.005%)

    Drug

    Additional intraocular eye pressure lowering post-Hydrus

  • Systane

    Drug

    Placebo Comparator (artificial tears)

Treatment groups

68 Participants
are divided into 2 treatment groups
Group A: Placebo Comparator Systane Artificial TearsPlacebo comparator 1 intervention
Group B: FDA Approved Rocklatan (netarsudil 0.02% and latanoprost 0.005%)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mean diurnal intraocular pressure change from baseline

After Hydrus prior to study initiation drop

Time frame
After 28 days up to 35 days post initiation of Rocklatan vs placebo comparator

Secondary outcomes

1

Diurnal Intraocular pressure change from baseline and difference between intraocular pressure at each time point

Goldmann Applanation Tonometry

Time frame
After Hydrus prior to study drop and after 28 days up to 35 days post initiation of study drop for all time points 8am, 10am, 4pm (± 1 hour) between groups

Other outcomes

1

Change in corneal hysteresis from baseline

Ocular Response Analyzer

Time frame
Change from baseline after 28 days up to 35 days post initiation of study drop

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Center for Sight Las Vegas

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: