Intraocular Pressure and Ocular Perfusion Pressure of Cosopt in Normal Tension Glaucoma

NCT01175902 | Completed Results DMC

• 1 other identifier: cosopt-IOP/OPP
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

To prove the non-inferiority of the fixed timolol-dorzolamide combination (Cosopt) compared to 0.005% latanoprost (Xalatan) in the aspects of intraocular pressure (IOP) and ocular perfusion pressure (OPP) in subjects with normal tension glaucoma (NTG) Clinical hypotheses. Primary hypothesis

• Cosopt group is non-inferior to Xalatan group in diurnal IOP reduction. Secondary hypothesis
• Cosopt group is non-inferior to Xalatan group in diurnal diastolic and systolic OPP.

Conditions

Normal Tension Glaucoma

Keywords

Normal tension glaucoma

Outcome Measures

Primary Outcomes (4)

• Intraocular Pressure (IOP), Period 1

  IOP (mean IOP) after 4 weeks of treatment

  4 weeks

• Intraocular Pressure (IOP), Period 2

  IOP (mean IOP) after treaemt from week 8 to week 12

  12 weeks

• Blood Pressure (BP), Period 1

  systolic and diastolic BP at 4 weeks after use of eyedrops

  4 weeks

• Blood Pressure (BP), Period 2

  systolic and diastolic BP measured after treaemt from week 8 to week 12

  12 weeks

Secondary Outcomes (2)

• Ocular Perfusion Pressure (OPP), Period 1

  4 weeks

• OPP, Period 2

  12 weeks

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Latanoprost first, then Dorzolamide/Timolol Patients first on Latanoprost eyedrops once a day, then on Dorzolamide/Timolol twice a day

Drug: dorzolamide/timolol; Drug: latanoprost

Arm 2

ACTIVE COMPARATOR

Dorzolamide/Timolol first, then Latanoprost Patients first on Dorzolamide/Timolol eyedrops twice a day, then on Latanoprost eyedrops once a day

Drug: dorzolamide/timolol; Drug: latanoprost

Interventions

dorzolamide/timolol DRUG

dorzolamide/timolol fixed combination eyedrop, 2 times a day

Also known as: Cosopt

Arm 1; Arm 2

latanoprost DRUG

compare with dorzolamide/timolol fixed combination eyedrop one time a day

Also known as: Xalatan

Arm 1; Arm 2

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ranging from 45 to 75 years
• best-corrected visual acuity no worse than 20/30 Snellen equivalent
• optic nerve head cupping (i.e., a vertical cup-to-disc ratio of more than 0.6) and/or notching of neuroretinal rim, and/or retinal nerve fiber defects characteristic of glaucoma
• visual field loss (i.e., a localized defect with at least three adjacent nonedge points depressed \>5 dB from the normal value, and a nucleus of at least one point depressed 10 dB from the normal value)
• repeated measurements of untreated IOP, which documented values less than 22 mmHg
• central corneal thickness ranging from 540 to 560 microns
• open-angle confirmed by gonioscopy

You may not qualify if:

• active or chronic systemic diseases and/or concomitant assumption of any medication known to affect IOP, BP and/or HR
• corneal abnormalities preventing reliable applanation tonometry
• severe ocular trauma, ocular inflammation or infection, intraocular surgery or argon laser treatment or laser trabeculoplasty
• myopic or other fundus changes preventing reliable optic disc evaluation,
• visual field defects caused by nonglaucomatous disease
• history of allergy to the ingredients of Cosopt or Xalatan eye drops

Sponsors & Collaborators

• The Catholic University of Korea: lead
• Seoul St. Mary's Hospital: collaborator

Study Sites (1)

Seoul St. Mary's hospital

Seoul, 137-070, South Korea

Location

Related Publications (1)

• Lee NY, Park HY, Park CK. Comparison of the Effects of Dorzolamide/Timolol Fixed Combination versus Latanoprost on Intraocular Pressure and Ocular Perfusion Pressure in Patients with Normal-Tension Glaucoma: A Randomized, Crossover Clinical Trial. PLoS One. 2016 Jan 12;11(1):e0146680. doi: 10.1371/journal.pone.0146680. eCollection 2016.

  PMID: 26756747 DERIVED

MeSH Terms

Conditions

Low Tension Glaucoma

Interventions

dorzolamide-timolol combination; Latanoprost

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases; Optic Nerve Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Chan Kee Park
• Organization: Seoul St. Mary's Hospital

ckpark@catholic.ac.kr

82222586208

Study Officials

• Chan Kee Park, M.D., PhD.

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Seoul St. Mary's Hospital

Study Record Dates

• First Submitted: July 26, 2010
• First Posted: August 5, 2010
• Study Start: March 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: January 8, 2015
• Results First Posted: December 12, 2014

Record last verified: 2014-12

Locations

KR (1)