Effect of Glucosamine on Intraocular Pressure

May 7, 2015 updated by: Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences
In this double blind clinical trial 92 patients suffering from rheumatoid arthritis are included. Those with the history of intraocular and corneal surgery, diabetic and heavy smokers are excluded from the study. Before starting the treatment all patients undergo complete ophthalmic exam, corneal biomechanical properties assessment by Ocular Response Analyzer (ORA) and corneal thickness measurement. Patients are randomly assigned to treatment and placebo groups. Those in the treatment groups receive glucosamine sulfate 1500 mg three times a day. Those in placebo arm receive alike capsule with the same schedule. At month 3 and 6 IOP(intraocular pressure), ORA and pachymetry would be checked again.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

41

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • History of rheumatoid arthritis based on ACR (American College of Rheumatology)FC(functional classes).
  • No history of using drugs tested in the study.

Exclusion Criteria:

  • History of any kind of corneal surgery.
  • History of intraocular surgery.
  • History of diabetes mellitus.
  • Heavy smokers.
  • Unwillingness to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Administration of the Placebo
Placebo three times a day.
Drug: Placebo three times a day
Other Names:
  • oral consumption
PLACEBO_COMPARATOR: Administration of the glucosamine sulfate
glucosamine sulfate 1500 mg three times a day
Drug: glucosamine sulfate 1500 mg three times a day
Other Names:
  • oral consumption

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular pressure changes
Time Frame: until 6 months
: Goldmann applanation tonometry
until 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
corneal biomechanical changes
Time Frame: until 6 months
Ocular Response Analyzer (ORA)
until 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (ANTICIPATED)

June 1, 2015

Study Registration Dates

First Submitted

September 25, 2014

First Submitted That Met QC Criteria

November 29, 2014

First Posted (ESTIMATE)

December 3, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

May 8, 2015

Last Update Submitted That Met QC Criteria

May 7, 2015

Last Verified

March 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 92182

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intraocular Pressure Changes After Glucosamine Sulfate Consumption.

Clinical Trials on Placebo three times a day

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Conditions

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Locations

3
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