MedDataX Logo

Will Restasis Eye Drops Increase Your Chance of Having a Successful Surgery?

NCT ID: NCT00405431

Last Updated: 2016-11-22

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2007-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Continued use of glaucoma drops can alter the outer surface of the eye and result in swelling and irritation, changing the structure of the eye. This structural change has been found to be a significant risk factor for the failure of glaucoma surgery. A comparison of how well patients do after glaucoma surgery depending on whether they use Restasis (the only prescription medication approved by the FDA for treating dry eye) or artificial tears (which can be purchased without a prescription) for 6 months following their surgery.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glaucoma

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

glaucoma filtering surgery restasis conjunctival inflammation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Patients received restasis eyedrops during 6 month post-operative period

Group Type ACTIVE_COMPARATOR

Restasis

Intervention Type DRUG

1 drop in study eye twice a day X 6 months

2

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

Group Type PLACEBO_COMPARATOR

Endura (artificial tears)

Intervention Type DRUG

1 drop in study eye twice a day X 6 months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Restasis

1 drop in study eye twice a day X 6 months

Intervention Type DRUG

Endura (artificial tears)

1 drop in study eye twice a day X 6 months

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Endura

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with uncontrolled glaucoma scheduled for filtering surgery

Exclusion Criteria

* Under 18 years of age
* Unable to understand informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Allergan

INDUSTRY

Sponsor Role collaborator

Wills Eye

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Marlene Moster, MD

Attending Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marlene R. Moster, MD

Role: PRINCIPAL_INVESTIGATOR

Wills Eye Glaucoma Research Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Wills Eye Glaucoma Service

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 20092592 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB #03-598

Identifier Type: -

Identifier Source: org_study_id