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OpenTrials
Completed

NCT Number: NCT00405431

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

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wills Eye Glaucoma Service

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with uncontrolled glaucoma scheduled for filtering surgery

Exclusion criteria

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

Treatment and study plan

Restasis

Drug

1 drop in study eye twice a day X 6 months

Endura (artificial tears)

Drug

1 drop in study eye twice a day X 6 months

Other names: Endura

Primary outcomes

  1. intraocular pressure

    Time frame: 6 months

Secondary outcomes

  1. ocular inflammation

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Wills Eye

Other

Collaborators

  • Allergan

Registry information

Official study title

Influence of Post-Operative Cyclosporine 0.05% (Restasis) on the Success of Glaucoma Filtering Surgery

Important dates

Study start
2004
Primary completion
2005
Study completion
2007
First posted
Nov 30, 2006
Registry last updated
Nov 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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