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Efficacy of 0.05 % Cyclosporine Ophthalmic Emulsion Compare With Tear in Meibomian Gland Dysfunction

Primary Purpose

Meibomian Gland Dysfunction

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
0.05% cyclosporin eye drop
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meibomian Gland Dysfunction focused on measuring Cyclosporine, Unstable tear film, Meibomian gland, Meibomian gland dysfunction

Eligibility Criteria

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

Inclusion Criteria:

  • Males or females, of legal age of consent
  • Patient has a diagnosis of meibomian gland dysfunction with at least 1 symptom as the following; ocular burning, ocular discomfort, and grittiness

  • Had a slit-lamp diagnosis of meibomian gland dysfunction based on the presence of one of the following

    • meibomian gland inflammation by lid margin or tarsal erythema, bulbar conjunctiva hyperemia, telangiectasia or thickening irregularity of the eyelid margins
    • meibomian gland orifice inclusion (plugging) or abnormal of secretion
  • Non-invasive tear break up time (NTBUT) with Tear scope Plus(Keeler, Windsor, UK) ≤ 8 seconds
  • Ability to follow study instruction and likely to complete all required visits

Exclusion Criteria:

  • Age < 18 years old
  • Patients with severe ocular disease from Steven Johnson syndrome burn, limbal deficiency
  • Patients used cyclosporine within past 1 year
  • Patients used oral cyclosporine or anticholinergic drug within past 2 months
  • Patients with HIV or autoimmune disease
  • Patients with active ocular infections and patients with a history of herpes keratitis
  • Patients with known or suspected hypersensitivity to any of the ingredients in the formula (cyclosporine, glycerin, castor oil, polysorbate 80, carbomer 1342)
  • Female patients are pregnant or nursing
  • Patients who wear contact lenses

Sites / Locations

  • Department of Ophthalmology; Siriraj Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

NTBUT

Secondary Outcome Measures

OSDI score, FTBUT, lid inflammation, meibomian gland secretion and expressibility, bulbar and tarsal conjunctival injection,fluorescein staining, rose bengal staining

Full Information

First Posted
June 24, 2008
Last Updated
November 8, 2010
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT00705510
Brief Title
Efficacy of 0.05 % Cyclosporine Ophthalmic Emulsion Compare With Tear in Meibomian Gland Dysfunction
Official Title
Efficacy of 0.05 % Cyclosporine Ophthalmic Emulsion Compare With Tear in Meibomian Gland Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the efficacy of 0.05% cyclosporine ophthalmic emulsion (Restasis® , Allergan) versus an artificial tears alone in patients with meibomian gland dysfunction that have abnormal tear quality and quantity by subjective symptoms and signs including tear breakup time
Detailed Description
Meibomian gland dysfunction patients will divide into 2 groups. One group will have 0.05% cyclosporine opthalmic emulsion and the other will have non-preservative artificial tear twice daily, compare the result in 3 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction
Keywords
Cyclosporine, Unstable tear film, Meibomian gland, Meibomian gland dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
0.05% cyclosporin eye drop
Other Intervention Name(s)
Restasis eye drop, Cellufresh eye drop
Intervention Description
use the medication twice daily for 3 months
Primary Outcome Measure Information:
Title
NTBUT
Time Frame
0,1,2,3 month
Secondary Outcome Measure Information:
Title
OSDI score, FTBUT, lid inflammation, meibomian gland secretion and expressibility, bulbar and tarsal conjunctival injection,fluorescein staining, rose bengal staining
Time Frame
0,1,2,3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males or females, of legal age of consent Patient has a diagnosis of meibomian gland dysfunction with at least 1 symptom as the following; ocular burning, ocular discomfort, and grittiness Had a slit-lamp diagnosis of meibomian gland dysfunction based on the presence of one of the following meibomian gland inflammation by lid margin or tarsal erythema, bulbar conjunctiva hyperemia, telangiectasia or thickening irregularity of the eyelid margins meibomian gland orifice inclusion (plugging) or abnormal of secretion Non-invasive tear break up time (NTBUT) with Tear scope Plus(Keeler, Windsor, UK) ≤ 8 seconds Ability to follow study instruction and likely to complete all required visits Exclusion Criteria: Age < 18 years old Patients with severe ocular disease from Steven Johnson syndrome burn, limbal deficiency Patients used cyclosporine within past 1 year Patients used oral cyclosporine or anticholinergic drug within past 2 months Patients with HIV or autoimmune disease Patients with active ocular infections and patients with a history of herpes keratitis Patients with known or suspected hypersensitivity to any of the ingredients in the formula (cyclosporine, glycerin, castor oil, polysorbate 80, carbomer 1342) Female patients are pregnant or nursing Patients who wear contact lenses
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pinnita Prabhasawat, MD
Organizational Affiliation
Department of Ophthalmology, Siriraj H, Mahidol U
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology; Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

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Efficacy of 0.05 % Cyclosporine Ophthalmic Emulsion Compare With Tear in Meibomian Gland Dysfunction

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