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

NCT ID: NCT01175902

Last Updated: 2015-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2014-10-31

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)

Conditions

Normal Tension Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

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

Group Type: ACTIVE_COMPARATOR

dorzolamide/timolol

Intervention Type: DRUG

dorzolamide/timolol fixed combination eyedrop, 2 times a day

latanoprost

Intervention Type: DRUG

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

Arm 2

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

Group Type: ACTIVE_COMPARATOR

dorzolamide/timolol

Intervention Type: DRUG

dorzolamide/timolol fixed combination eyedrop, 2 times a day

latanoprost

Intervention Type: DRUG

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

Interventions

dorzolamide/timolol

dorzolamide/timolol fixed combination eyedrop, 2 times a day

Intervention Type: DRUG

latanoprost

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

Intervention Type: DRUG

Other Intervention Names

Cosopt; Xalatan

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Seoul St. Mary's Hospital

OTHER

Sponsor Role: collaborator

The Catholic University of Korea

OTHER

Sponsor Role: lead

Responsible Party

Chan Kee Park

Seoul St. Mary's Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chan Kee Park, M.D., PhD.

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea

Locations

Seoul St. Mary's hospital

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 26756747 (View on PubMed)

Other Identifiers

cosopt-IOP/OPP

Identifier Type: -

Identifier Source: org_study_id