Health TrialsbyHealthPanel

Efficacy of Simbrinza and Rocklatan vs Cosopt and Latanoprost

ConditionOpen Angle Glaucoma
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorPrairie Eye Center

About this trial

A randomized, multi-site, parallel-group, prospective study of patients who are adults with a diagnosis of mild to moderate open-angle glaucoma (OAG), currently on an on-label use of combination topical medication of Cosopt and Latanoprost for a minimum of 1 month.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Optic disc or retinal nerve fiber layer (RNFL) structural abnormalities

Diffuse or focal narrowing, or notching, of the optic disc rim, especially at the inferior or superior poles, which forms the basis for the ISNT rule

Progressive narrowing of the neuroretinal rim with an associated increase in cupping of the optic disc

Diffuse or localized abnormalities of the parapapillary RNFL, especially at the inferior or superior poles

Disqualifiers

Patients with prior ocular procedures or intraocular surgery within 1 year prior to baseline (e.g. cataract surgery).

Patients with prior history of glaucoma surgeries or laser treatment except patients with history of SLT >1 yr prior to baseline.

Contraindications or known hypersensitivity to any or all the study medications including Rocklatan, Simbrinza, Cosopt and Latanoprost or related class of drugs.

Patients with known history or presence of uncontrolled systemic diseases including diseases that, in investigator's opinion, may make it unsafe or undesirable for the subject to participate in the study and/ or limit adherence.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Simbrinza 0.2%-1% Ophthalmic Suspension

    Drug

    brinzolamide and brimonidine tartrate

  • Rocklatan 0.02%-0.005% Ophthalmic Solution

    Drug

    netarsudil and latanoprost

  • Cosopt PF 2%-0.5% Ophthalmic Solution

    Drug

    dorzolamide hydrochloride and timolol maleate

  • Latanoprost 0.005% Ophthalmic Solution

    Drug

    Latanoprost

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Simbrinza and RocklatanExperimental treatment 2 interventions
Group B: Cosopt and LatanoprostActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Decrease in mean diurnal IOP

Mean diurnal IOP is determined as the average IOP measured at 8:30am, 12:00pm and 3:30pm

Time frame
from baseline at week 8

Secondary outcomes

1

Mean decrease in IOP at 8:30am

Time frame
from baseline at week 8
2

Mean decrease in IOP at 12:00pm

Time frame
from baseline at week 8
3

Mean decrease in IOP at 4:30pm

Time frame
from baseline at week 8

Other outcomes

1

Mean % IOP diurnal reduction

Determined as the percentage decrease in average IOP measured at 8:30am, 12:00pm and 3:30pm

Time frame
from baseline at week 8

Sponsors and contacts

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

Prairie Eye Center

Lead sponsor

Sengi

Collaborator

Source ClinicalTrials.gov
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