Effect of Glucosamine on Intraocular Pressure

Phase 3

• Conditions: Intraocular Pressure Changes After Glucosamine Sulfate Consumption.
• Interventions: Drug: Placebo three times a day; Drug: glucosamine sulfate 1500 mg three times a day

• Registration Number: NCT02306083
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-03
• Study Start: 2014-07
• Study First Submitted: 2014-09-25
• Study First Submitted QC: 2014-11-29
• Study First Posted: 2014-12-03
• Last Update Submitted: 2015-05-07
• Last Update Posted: 2015-05-08
• Primary Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Administration of the Placebo	Placebo three times a day	Placebo three times a day.
Administration of the glucosamine sulfate	glucosamine sulfate 1500 mg three times a day	glucosamine sulfate 1500 mg three times a day

Primary Outcome Measures

Name	Time	Method
Intraocular pressure changes	until 6 months	: Goldmann applanation tonometry

Secondary Outcome Measures

Name	Time	Method
corneal biomechanical changes	until 6 months	Ocular Response Analyzer (ORA)

Trial Locations

Locations (1)

Islamic Republic OF Iran; 🇮🇷 Tehran, Iran, Islamic Republic of