NCT00405431

Brief Summary

The purpose of this study is to determine whether reducing inflammation of the surface of the eye with topical Restasis after glaucoma surgery will improve surgical outcomes and increase patient comfort.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2004

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2006

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

November 22, 2016

Status Verified

November 1, 2016

Enrollment Period

1.3 years

First QC Date

November 28, 2006

Last Update Submit

November 20, 2016

Conditions

Glaucoma

Keywords

glaucoma filtering surgeryrestasisconjunctival inflammation

Outcome Measures

Primary Outcomes (1)

  • intraocular pressure

    6 months

Secondary Outcomes (1)

  • ocular inflammation

    6 months

Study Arms (2)

1

ACTIVE COMPARATOR

Patients received restasis eyedrops during 6 month post-operative period

Drug: Restasis

2

PLACEBO COMPARATOR

Patients receive artificial tears (Endura) during 6 month post-operative period

Drug: Endura (artificial tears)

Interventions

RestasisDRUG

1 drop in study eye twice a day X 6 months

1
Endura (artificial tears)DRUG

1 drop in study eye twice a day X 6 months

Also known as: Endura
2

Eligibility Criteria

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

You may qualify if:

  • Patients with uncontrolled glaucoma scheduled for filtering surgery

You may not qualify if:

  • Under 18 years of age
  • Unable to understand informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wills Eye Glaucoma Service

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

  • Fakhraie G, Lopes JF, Spaeth GL, Almodin J, Ichhpujani P, Moster MR. Effects of postoperative cyclosporine ophthalmic emulsion 0.05% (Restasis) following glaucoma surgery. Clin Exp Ophthalmol. 2009 Dec;37(9):842-8. doi: 10.1111/j.1442-9071.2009.02134.x.

    PMID: 20092592RESULT

MeSH Terms

Conditions

Glaucoma

Interventions

CyclosporinsLubricant Eye Drops

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsOphthalmic SolutionsPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesLubricantsSpecialty Uses of Chemicals

Study Officials

  • Marlene R. Moster, MD

    Wills Eye Glaucoma Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Surgeon

Study Record Dates

First Submitted

November 28, 2006

First Posted

November 30, 2006

Study Start

March 1, 2004

Primary Completion

June 1, 2005

Study Completion

November 1, 2007

Last Updated

November 22, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will share

manuscript has been published.

Locations

US(1)