CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 139 enrolled
Drug / intervention
Manual Mini System +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00832130
NCT00832130N/ACompleted
CompareCT.gov

Randomized Clinical Trial for Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye

TearScience, Inc.·interventional·Posted Jan 29, 2009·Updated Dec 12, 2011

In Brief

A clinical study evaluating Manual Mini System and iHeat Portable Warm Compress Therapy for Chalazion and Dry Eye Syndromes. Completed, enrolled 139 participants across 11 sites.

Detailed Summary

The objective of this study is to evaluate the clinical utility, safety and effectiveness of the Manual Mini System compared to standardized warm compress therapy for application of controlled, localized heat therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye, and chalazia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChalazion, Dry Eye Syndromes
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 29, 2009
Enrollment StartFeb 1, 2009
Primary CompletionJun 1, 2009
Study CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 17.4 years ago

Interventions

Manual Mini Systemdevice

In-office device treatment for meibomian gland dysfunction by a physician

iHeat Portable Warm Compress Therapydevice

At-home daily warm compress therapy