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Compares treatment options for Open Angle Glaucoma
Official title 24-hour Effect of Rocklatan Compared With Latanoprost in Open Angle Glaucoma and Ocular Hypertension Patients
ClinicalTrials.gov ID: NCT07325240
What this study is testing
What is Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution?
Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution is an investigational medicine, given as an once-daily, being studied as a potential treatment for open angle glaucoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the effect on 24-hour IOP reduction of netarsudil-latanoprost fixed combination in one eye compared to latanoprost alone in the contralateral eye, dosed daily, 1 drop at night (QD, PM) in adult subjects, at least 18 years of age, with open angle glaucoma (OAG) or ocular hypertension (OHT).
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosis of OHT or mild-to-moderate OAG in both eyes (OAG in one eye and OHT in the fellow eye is acceptable) based on VF, OCT and dilated fundus...
- Both eyes must qualify for the study with an IOP of ≥18 mmHg but ≤34 mmHg on history or at the screening visit
- Be able and willing to provide signed informed consent and follow study instructions
- Ability to cooperate with the examinations required for the study and be able to attend all study visits
- If a contact lens wearer, willing to remove contact lenses at least 24 hours prior to each of the study visits.
You likely can't join if
- Ocular:
- people with narrow angles (3 quadrants with Grade 2 or less according to Shaffer Scale), angle closure or a history of angle closure, or peripheral...
- Severe glaucomatous damage
- Difference in IOP between eyes \> 4 mmHg (unmedicated) at any baseline time point
- Use of more than two ocular hypotensive medications within 30 days of screening
- Chronic or recurrent inflammatory eye diseases in either eye
See the full eligibility criteria
- Diagnosis of OHT or mild-to-moderate OAG in both eyes (OAG in one eye and OHT in the fellow eye is acceptable) based on VF, OCT and dilated fundus examination within one year of the screening visit.
- Both eyes must qualify for the study with an IOP of ≥18 mmHg but ≤34 mmHg on history or at the screening visit
- Be able and willing to provide signed informed consent and follow study instructions
- Ability to cooperate with the examinations required for the study and be able to attend all study visits
- If a contact lens wearer, willing to remove contact lenses at least 24 hours prior to each of the study visits.
- Best-corrected visual acuity (BCVA) using ETDRS chart of +0.4 logMAR units (Snellen equivalent \~ 20/50) or better in each eye
- Ocular:
- people with narrow angles (3 quadrants with Grade 2 or less according to Shaffer Scale), angle closure or a history of angle closure, or peripheral iridotomy in either eye
- Severe glaucomatous damage
- Difference in IOP between eyes \> 4 mmHg (unmedicated) at any baseline time point
- Use of more than two ocular hypotensive medications within 30 days of screening
- Chronic or recurrent inflammatory eye diseases in either eye
- Ocular infection or ocular inflammation in the past 3 months in either eye
- Ocular trauma other than corneal abrasion within the past 6 months in either eye
- Clinically significant retinal disease (e.g., severe diabetic retinopathy, exudative or severe non-exudative macular degeneration, macular edema, retinal vein or artery occlusion) in either eye
- Cornea pathologic changes preventing reliable measurement (e.g., scarring, opacity, edema, keratoconus) in either eye
- Myopia greater than -6.00D, or hyperopia greater than +2.00D in either eye
- Central corneal thickness less than 480 μm or greater than 620 μm in either eye
- Previous intraocular surgery other than routine uncomplicated cataract surgery in either eye
- Previous glaucoma intraocular surgery or glaucoma laser procedures (except SLT performed more than 6 months ago) in either eye
- Unilateral intraocular surgery or glaucoma laser procedures
- Previous corneal refractive surgery in either eye (eg, radial keratotomy, PRK, LASIK, corneal cross-linking, etc.)
- Severe dry eye in either eye
- Use of ocular medications in either eye within 30 days of screening, with the exception of IOP-lowering medications (which must be washed out according to the provided schedule), and lubricating drops for dry eye (which...
- Known hypersensitivity to any component of the formulation (eg, benzalkonium chloride, etc.), or to topical anesthetic Systemic:
- Clinically significant systemic diseases which might interfere with the study
- Participation in any treatment study within 30 days prior to screening visit
- Changes of systemic medication that could have an effect on IOP within 30 days prior to screening, or anticipated during the study including, β-adrenergic antagonists, α-adrenergic agonists and antagonists, angiotensin...
- Recent change in medications that are known to affect IOP within 30 days prior to the screening visit and during the study including: systemic/inhaled steroids, calcium channel blockers, diuretics, and vasodilators
- Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. An adult woman is considered to be of childbearing potential unless she is one...
- people with a known hypersensitivity or contraindications to any of the ingredients in the study medications
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.