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

NCT ID: NCT00705510

Last Updated: 2010-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-10-31

Brief Summary

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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

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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.

Conditions

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Meibomian Gland Dysfunction

Keywords

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Cyclosporine Unstable tear film Meibomian gland Meibomian gland dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Group Type ACTIVE_COMPARATOR

0.05% cyclosporin eye drop

Intervention Type DRUG

use the medication twice daily for 3 months

B

Group Type PLACEBO_COMPARATOR

0.05% cyclosporin eye drop

Intervention Type DRUG

use the medication twice daily for 3 months

Interventions

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0.05% cyclosporin eye drop

use the medication twice daily for 3 months

Intervention Type DRUG

Other Intervention Names

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Restasis eye drop, Cellufresh eye drop

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Department of Ophthalmology; Siriraj Hospital

Principal Investigators

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Pinnita Prabhasawat, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology, Siriraj H, Mahidol U

Locations

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Department of Ophthalmology; Siriraj Hospital

Bangkok, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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154/2551(EC1)

Identifier Type: -

Identifier Source: org_study_id