Efficacy of Simbrinza and Rocklatan vs Cosopt and Latanoprost

Last updated: May 14, 2025
Sponsor: Prairie Eye Center
Overall Status: Active - Recruiting

Phase

4

Condition

Glaucoma

Open Angle Glaucoma

Treatment

Simbrinza 0.2%-1% Ophthalmic Suspension

Latanoprost 0.005% Ophthalmic Solution

Cosopt PF 2%-0.5% Ophthalmic Solution

Clinical Study ID

NCT06883123
SY-25-01
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Inclusion

Inclusion criteria:

  • Adults aged Eighteen (18) years and older with a diagnosis of mild to moderateopen-angle glaucoma (OAG), currently on an on-label use of combination topicalmedication of Cosopt and Latanoprost for a minimum of 1 month. Evidence of opticnerve damage will be based on AAO Preferred Practice Patterns guidelines usingeither or both of the following:

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

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

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

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

  • Disc rim, parapapillary RNFL, or lamina cribrosa hemorrhages

  • Optic disc neural rim asymmetry of the two eyes consistent with loss of neuraltissue

  • Large extent of parapapillary atrophy

  • Reliable and reproducible visual field abnormality considered a valid representationof the subject's functional status

  • Visual field damage consistent with RNFL damage (e.g. nasal step, arcuate fielddefect, or paracentral depression in clusters of test sites)

  • Visual field loss across the horizontal midline in one hemifield that exceeds lossin the opposite hemifield (in early/ moderate cases)

  • Absence of other known explanations (e.g. optic disc drusen, optic nerve pit)

  • Mean diurnal IOP ≥ 18 mmHg and < 28 mmHg at baseline in at least one eye with aninter-eye IOP difference < 5 mmHg.

  • A central corneal thickness (CCT) within the range of 450-650 µm

Exclusion

Exclusion criteria:

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

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

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

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

  • Patients with known history or presence of significant ocular diseases includingcorneal diseases, dystrophies or abnormalities that would prevent accurate IOPreadings with GAT.

  • Patients with a history of uncontrolled IOP with the combination of either Rocklatan

  • Simbrinza or Cosopt + Latanoprost dual therapy.
  • Significant ocular surface findings (e.g. hyperemia, irritation) found during slitlamp examination that might affect the study.

  • Chronic use of any systemic medication for chronic diseases that may affect IOP.

  • Subjects who are pregnant, lactating or planning a pregnancy.

  • Any condition in the opinion in the investigator that would potentially confound theresults of this study

Study Design

Total Participants: 70
Treatment Group(s): 4
Primary Treatment: Simbrinza 0.2%-1% Ophthalmic Suspension
Phase: 4
Study Start date:
May 14, 2025
Estimated Completion Date:
April 01, 2026

Connect with a study center

  • Prairie Eye Center

    Springfield, Illinois 62704
    United States

    Active - Recruiting

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