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Evaluation of Omeprazole Effect on Glaucoma

Primary Purpose

Glaucoma

Status
Unknown status
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Omeprazole
Placebo
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with glaucoma
  • 18 to 70 years
  • POAG patients, Pseudoexfoliation
  • no history of other systemic disease
  • no history of intraocular intervention
  • no history of H2 blocker or PPI consumption during the past month consuming 2 or less topical anti-glaucoma medication
  • no present immune deficiency
  • no addiction habit

Exclusion Criteria:

Sites / Locations

  • Ophthalmic Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Omeprazole

placebo

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 7, 2009
Last Updated
May 3, 2010
Sponsor
Shahid Beheshti University of Medical Sciences
Collaborators
Ophthalmic Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT01000220
Brief Title
Evaluation of Omeprazole Effect on Glaucoma
Official Title
Evaluation of Omeprazole Effect on Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Shahid Beheshti University of Medical Sciences
Collaborators
Ophthalmic Research Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Omeprazole is a safe drug listed in OTC drug due to its safety. It acts by irreversible inhibition of K/H ATP ase pump and also Na/K ATP ase, Na/H ATP ase.Considering these actions the effect of omeprazole on decreasing intra ocular pressure is an issue of debate.In this Randomized Clinical Trial conducted in labafinejad hospital, patients with glaucoma who need to take omeprazole due to GI problem are evaluated in two groups including placebo and drug users. The effect will be finally assessed.
Detailed Description
Omeprazole is a safe drug listed in OTC drug due to its safety. It acts by irreversible inhibition of K/H ATP ase pump and also Na/K ATP ase, Na/H ATP ase.Considering these actions the effect of omeprazole on decreasing intra ocular pressure is an issue of debate.In this Randomized Clinical Trial conducted in labafinejad hospital, patients with glaucoma who need to take omeprazole due to GI problem are evaluated in two groups including placebo and drug users. The effect will be finally assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized

8. Arms, Groups, and Interventions

Arm Title
Omeprazole
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Omeprazole
Intervention Type
Drug
Intervention Name(s)
Placebo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with glaucoma 18 to 70 years POAG patients, Pseudoexfoliation no history of other systemic disease no history of intraocular intervention no history of H2 blocker or PPI consumption during the past month consuming 2 or less topical anti-glaucoma medication no present immune deficiency no addiction habit Exclusion Criteria:
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yazdani Shahin, MD
Phone
+982122585952
Email
labbafi@hotmail.com
Facility Information:
Facility Name
Ophthalmic Research Center
City
Tehran
ZIP/Postal Code
166666
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shahin yazdani, MD
Phone
+98 21 22585952
Email
labbafi@hotmail.com

12. IPD Sharing Statement

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Evaluation of Omeprazole Effect on Glaucoma

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