24-hour Effect of Rocklatan Compared With Latanoprost in Open Angle Glaucoma and Ocular Hypertension Patients

ConditionsOpen Angle Glaucoma Ocular Hypertension

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorMayo Clinic

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Subjects 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

Trial design

Design model

Parallel

Treatments tested in this trial

Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution
Drug
Subjects will receive netarsudil-latanoprost fixed combination ophthalmic solution 0.02%/0.005% in one eye and compare it to latanoprost 0.005% in the contralateral eye
Latanoprost 0.005% Ophthalmic Solution
Drug
latanoprost 0.005% solution will be applied in the contralateral eye, once daily, QD (PM) for 14 days

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: netarsudil-latanoprost armExperimental treatment 1 intervention

Group B: latanoprost armActive comparator 1 intervention

Trial outcomes

Primary outcomes

Change in mean Intraocular Pressure (IOP)

Change in mean IOP from baseline at each time point for Latanoprost

Time frame

Change in mean IOP after 2 weeks of treatment with Latanoprost compared to baseline

Change in mean IOP

Change in mean IOP from baseline at each time point for Rocklatan

Time frame

Change in mean IOP after 2 weeks of treatment with Rocklatan compared to baseline

Change in mean IOP

Change in mean IOP from Latanoprost at each time point for Rocklatan

Time frame

Change in mean IOP from baseline after 2 weeks of treatment with latanoprost minus change in mean IOP from baseline after 2 weeks of treatment with Rocklatan

Secondary outcomes

Change in mean nocturnal IOP

Change in mean nocturnal IOP (both absolute and % change) from baseline for Latanoprost

Time frame

Mean nocturnal IOP will be calculated based on the time points during the sleeping hours (11 PM - 7 AM) after 2 weeks of treatment with Latanoprost compared to baseline

Change in mean nocturnal IOP

Change in mean nocturnal IOP (both absolute and % change) from baseline for Rocklatan

Time frame

Mean nocturnal IOP will be calculated based on the time points during the sleeping hours (11 PM - 7 AM) after 2 weeks of treatment with Rocklatan compared to baseline

Change in mean diurnal IOP

Change in mean diurnal IOP (both absolute and % change) from baseline for Latanoprost

Time frame

Mean diurnal IOP will be calculated based on the time points during the sleeping hours (7 AM - 11 PM) after 2 weeks of treatment with Latanoprost compared to baseline

Change in mean diurnal IOP

Change in mean diurnal IOP (both absolute and % change) from baseline for Rocklatan

Time frame

Mean diurnal IOP will be calculated based on the time points during the sleeping hours (7 AM - 11 PM) after 2 weeks of treatment with Rocklatan compared to baseline

Other outcomes

24-hour IOP variability

24-hour IOP variability based on standard deviation and range of measurements from 12 time points over a 24-hour period, and circadian amplitude from cosinor analysis of the 24-hour curve

Time frame

During the time period of analysis, approximately 18 months

Diurnal IOP variability

Diurnal IOP variability based on standard deviation and range of measurements during the waking period

Time frame

During the time period of analysis, approximately 18 months

Nocturnal IOP variability

Nocturnal IOP variability based on standard deviation and range of measurements during the sleeping period

Time frame

During the time period of analysis, approximately 18 months

Sponsors and contacts

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

Mayo Clinic

Lead sponsor

Alcon Research

Collaborator

Source ClinicalTrials.gov

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