NCT01284439

Brief Summary

To study effect of hydroxypropylmethylcellulose 0.3% and sodium hyaluronate 0.18% in the treatment of ocular surface disease in glaucoma patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

January 27, 2011

Status Verified

January 1, 2011

Enrollment Period

1 year

First QC Date

January 25, 2011

Last Update Submit

January 26, 2011

Conditions

Ocular Surface DiseaseGlaucoma

Outcome Measures

Primary Outcomes (1)

  • Ocular surface index score

    1 month

Secondary Outcomes (1)

  • Eye lid inflammation, corneal staining score, tear break up time and tear volume

    1 month

Study Arms (2)

TearA

EXPERIMENTAL
Drug: hydroxypropylmethylcellulose

TearB

EXPERIMENTAL
Drug: sodium hyaluronate

Interventions

hydroxypropylmethylcelluloseDRUG

TearA: QID to every 2 hous , 1-2 drops per each time , duration 1 month

TearA
sodium hyaluronateDRUG

QID to every 2 hous, 1-2 drops per each time, duration 1 month

TearB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • OSDI \> or equal 20 and eye lid inflammation , meibomian gland inflammation,conjunctival injection,follicle at tarsus , positive corneal staining , tear break up time less than 8 seconds , tear volume less than 5.5 mm.

You may not qualify if:

  • Age below 18 yo
  • Active infectious corneal disease
  • Post penetrating keratoplasty or glaucoma drainage device
  • Known allergy to medication
  • Lactation , Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology , Siriraj Hospital

Bangkok, Bangkok, Thailand

RECRUITING

MeSH Terms

Conditions

Glaucoma

Interventions

Hypromellose DerivativesHyaluronic Acid

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

CelluloseGlucansBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureGlycosaminoglycans

Study Officials

  • AssocProf Pinnita Tanthuvanit, MD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

AssocProf Pinnita Tanthuvanit

CONTACT

02-4198036

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 25, 2011

First Posted

January 27, 2011

Study Start

January 1, 2011

Primary Completion

January 1, 2012

Study Completion

February 1, 2012

Last Updated

January 27, 2011

Record last verified: 2011-01

Locations

TH(1)