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Effect of Glucosamine on Intraocular Pressure

Sponsor
Shahid Beheshti University of Medical Sciences (Other)
Overall Status
Unknown status
CT.gov ID
NCT02306083
Collaborator
(none)
41
Enrollment
1
Location
2
Arms

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Placebo three times a day
  • Drug: glucosamine sulfate 1500 mg three times a day
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
41 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Prevention
Study Start Date :
Jul 1, 2014
Anticipated Primary Completion Date :
Jun 1, 2015

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Intraocular pressure changes [until 6 months]

      : Goldmann applanation tonometry

    Secondary Outcome Measures

    1. corneal biomechanical changes [until 6 months]

      Ocular Response Analyzer (ORA)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Islamic Republic OF Iran Tehran Iran, Islamic Republic of

    Sponsors and Collaborators

    • Shahid Beheshti University of Medical Sciences

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zahra Rabbani Khah, clinical professor ,ophthalmic research center, Shahid Beheshti University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT02306083
    Other Study ID Numbers:
    • 92182
    First Posted:
    Dec 3, 2014
    Last Update Posted:
    May 8, 2015
    Last Verified:
    Mar 1, 2014

    Study Results

    No Results Posted as of May 8, 2015