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

Primary Purpose

Normal Tension Glaucoma

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
dorzolamide/timolol
latanoprost
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Normal Tension Glaucoma focused on measuring Normal tension glaucoma

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

The identification of NTG was based on reproducible glaucomatous visual field defects, corresponding to typical ONH changes.

Unilateral or bilateral visual field loss (description as below) as determined by at least two consecutive automated static threshold perimetry tests.

One eye is randomly selected in the cases where both eyes are treated.

Inclusion criteria:

  1. age ranging from 45 to 75 years
  2. best-corrected visual acuity no worse than 20/30 Snellen equivalent
  3. 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
  4. 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)
  5. repeated measurements of untreated IOP, which documented values less than 22 mmHg
  6. central corneal thickness ranging from 540 to 560 microns
  7. open-angle confirmed by gonioscopy

Exclusion criteria:

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

Sites / Locations

  • Seoul St. Mary's hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Intraocular Pressure (IOP), Period 1
IOP (mean IOP) after 4 weeks of treatment
Intraocular Pressure (IOP), Period 2
IOP (mean IOP) after treaemt from week 8 to week 12
Blood Pressure (BP), Period 1
systolic and diastolic BP at 4 weeks after use of eyedrops
Blood Pressure (BP), Period 2
systolic and diastolic BP measured after treaemt from week 8 to week 12

Secondary Outcome Measures

Ocular Perfusion Pressure (OPP), Period 1
OPP was calculated according to the following formula: OPP=(1/3 systolic BP + 2/3 diastolic BP) x 2/3 -IOP, diastolic OPP (DOPP)=diastolic BP-IOP
OPP, Period 2
OPP was calculated according to the following formula: OPP=(1/3 systolic BP + 2/3 diastolic BP) x 2/3 -IOP, diastolic OPP (DOPP)=diastolic BP-IOP OPP after treaemt from week 8 to week 12

Full Information

First Posted
July 26, 2010
Last Updated
December 12, 2014
Sponsor
The Catholic University of Korea
Collaborators
Seoul St. Mary's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01175902
Brief Title
Intraocular Pressure and Ocular Perfusion Pressure of Cosopt in Normal Tension Glaucoma
Official Title
To Prove the Non-inferiority of Cosopt Compared to Xalatan in the Aspects of Intraocular Pressure and Ocular Perfusion Pressure in Subjects With Normal Tension Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea
Collaborators
Seoul St. Mary's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Cosopt (dorzolamide/timolol fixed combination) has well known effect for IOP reduction in POAG and OHT.3-5 However, there is no study about the effect and safety of Cosopt in NTG, Cosopt is not used the first line drug in the management of NTG. In Korea, the prevalence of NTG is higher than western countries, the majority (about 80-90%) of open angle glaucoma patients have an IOP of 21 mmHg or less, so the study of NTG is important and searching of effective drug for the treatment of NTG is necessary. In this study, we would prove the non-inferiority of Cosopt compared to Xalatan,6 which is used as a first line drug in the management of NTG, in the aspects of IOP and OPP including diastolic OPP (DOPP). A prospective, interventional, randomized, crossover, single masked, single center study. Forty-four NTG patients were randomly allocated to one of two groups. Patients in group A were treated with Cosopt, lubricant, and Xalatan for 4 weeks each, whereas patients in group B were treated with Xalatan, lubricant, and Cosopt for 4 weeks each. Recruit NTG patients, who are not treated with the glaucoma medication recent 2 months. If treated, after washout period of 4 weeks, the patients can be included in the study. Baseline IOP, systolic and diastolic BP will be measured. (Day 1) After 4 weeks of treatment of Cosopt or Xalatan, all participants will be checked diurnal IOP, systolic and diastolic BP. IOP was measured by Goldmann applanation tonometry (mean of three consecutive readings) with the patient in a sitting position at the slit lamp. Every IOP will be measured by one masked glaucoma specialist who is unaware of the treatment assignments. After the IOP measurements, after a 5-minite rest, pulse rate and BP (systolic and diastolic) of radial artery were measured in the sitting position using a standard automated blood pressure cuff. During the period, all measuring instruments keep to be calibrated by the manufacturer's instruction. - OPP was calculated according to the following formula: OPP=(1/3 systolic BP + 2/3 diastolic BP) x 2/3 -IOP, diastolic OPP (DOPP)=diastolic BP-IOP. During the 4 weeks washout period, subjects will use lubricants.(Week 8) In this crossover study, with the other eye drops, the same measurement will be performed. (Week 12)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Normal Tension Glaucoma
Keywords
Normal tension glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Active Comparator
Arm Description
Latanoprost first, then Dorzolamide/Timolol Patients first on Latanoprost eyedrops once a day, then on Dorzolamide/Timolol twice a day
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
Dorzolamide/Timolol first, then Latanoprost Patients first on Dorzolamide/Timolol eyedrops twice a day, then on Latanoprost eyedrops once a day
Intervention Type
Drug
Intervention Name(s)
dorzolamide/timolol
Other Intervention Name(s)
Cosopt
Intervention Description
dorzolamide/timolol fixed combination eyedrop, 2 times a day
Intervention Type
Drug
Intervention Name(s)
latanoprost
Other Intervention Name(s)
Xalatan
Intervention Description
compare with dorzolamide/timolol fixed combination eyedrop one time a day
Primary Outcome Measure Information:
Title
Intraocular Pressure (IOP), Period 1
Description
IOP (mean IOP) after 4 weeks of treatment
Time Frame
4 weeks
Title
Intraocular Pressure (IOP), Period 2
Description
IOP (mean IOP) after treaemt from week 8 to week 12
Time Frame
12 weeks
Title
Blood Pressure (BP), Period 1
Description
systolic and diastolic BP at 4 weeks after use of eyedrops
Time Frame
4 weeks
Title
Blood Pressure (BP), Period 2
Description
systolic and diastolic BP measured after treaemt from week 8 to week 12
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Ocular Perfusion Pressure (OPP), Period 1
Description
OPP was calculated according to the following formula: OPP=(1/3 systolic BP + 2/3 diastolic BP) x 2/3 -IOP, diastolic OPP (DOPP)=diastolic BP-IOP
Time Frame
4 weeks
Title
OPP, Period 2
Description
OPP was calculated according to the following formula: OPP=(1/3 systolic BP + 2/3 diastolic BP) x 2/3 -IOP, diastolic OPP (DOPP)=diastolic BP-IOP OPP after treaemt from week 8 to week 12
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
The identification of NTG was based on reproducible glaucomatous visual field defects, corresponding to typical ONH changes. Unilateral or bilateral visual field loss (description as below) as determined by at least two consecutive automated static threshold perimetry tests. One eye is randomly selected in the cases where both eyes are treated. Inclusion criteria: 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 Exclusion criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chan Kee Park, M.D., PhD.
Organizational Affiliation
The Catholic University of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul St. Mary's hospital
City
Seoul
ZIP/Postal Code
137-070
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
26756747
Citation
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.
Results Reference
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Intraocular Pressure and Ocular Perfusion Pressure of Cosopt in Normal Tension Glaucoma

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