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Completed

NCT Number: NCT01244334

Study of Difluprednate vs. Prednisolone Acetate on Visual Acuity, and Corneal Edema Following Cataract Surgery.

The purpose of this clinical research study is to investigate the efficacy of predosing patients undergoing cataract surgery with the potent corticosteroid difluprednate ophthalmic emulsion 0.05% compared to prednisolone acetate 1% on corneal edema (swelling), and retinal thickness.

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Key information

Conditions

Cataracts Cataract Corneal Diseases Corneal Edema Eye Diseases Lens Diseases Retinal Structural Change, Deposit and Degeneration Visual Acuity Reduced Transiently

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cincinnati Eye Institute, Edgewood, Kentucky, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Healthy male or female 21 years of age or older
  • Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 6-25 days between surgeries.
  • Willing and able to administer eye drops and record the times the drops were instilled
  • Understand and are willing to sign the Informed Consent form
  • Willing to complete the entire course of the study.

Exclusion criteria

  • Use of an eye medication or drops within 48 hours of the scheduled cataract surgery, other than the study medication or procedural solution required for surgery.
  • Known sensitivity to any of the ingredients in the study medications or similar medications.
  • Scheduled for 2nd eye cataract surgery earlier than 6 days or longer than 25 days apart.
  • Corneal edema in either eye.
  • Need for regional or general anesthesia during surgery.
  • Complicated cataract surgery, including use of iris hooks or iris stretchers.
  • Sight better than 20/100 in only one eye.
  • A history of previous intraocular surgery in either eye.
  • A history of uveitis, iritis, or intraocular inflammation.
  • Macular pathology of the retina.
  • Presence of glaucoma.
  • Any confirmed or suspected active viral, bacterial, or fungal keratoconjunctival disease.
  • History of steroid-related intraocular pressure (IOP) rise in the study eye.
  • Lack of an intact corneal epithelium.
  • Pupils that do not dilate to more than 5 mm prior to surgery or you require mechanical stretching of your pupil.
  • Diabetes mellitus.
  • Required use of a systemic steroidal or non-steroidal anti-inflammatory during the study period.
  • Doctor has determined the presence of a condition (i.e., UNCONTROLLED systemic disease) or a situation that may put the subject at significant risk, confound the study results or may interfere significantly with your participation in the study.
  • Females, who are pregnant, nursing an infant or planning a pregnancy.
  • Currently involved in another investigational study or have participated in one within the 30 days prior to entering this study.
  • Unable or unwilling to give signed informed consent prior to participation in any study-related procedures.

Treatment and study plan

Difluprednate ophthalmic emulsion 0.05%

Drug

Difluprednate ophthalmic emulsion 0.05%: 29 days total, total of 7 drops prior to surgery, and 3 more following surgery while at the surgery center, then Q2H on day of surgery, then QID for 1 week, then BID for 1 week, then stop.

Other names: Durezol

Prednisolone acetate 1%

Drug

Prednisolone acetate 1% : 29 days total, total of 7 drops prior to surgery, and 3 more following surgery while at the surgery center, then Q2H on day of surgery, then QID for 1 week, then BID for 1 week, then stop.

Other names: Prednisolone acetate

Primary outcomes

  1. Assess change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 1

    Time frame: Change from Baseline in visual acuity, corneal edema, and retinal thickness at Day 1

Secondary outcomes

  1. Assess change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 15

    Time frame: change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 15

Other outcomes

  1. change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 30

    Time frame: change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 30

Sponsors and collaborators

Lead sponsor

Edward J. Holland

Other

Collaborators

  • Alcon Research
  • Parsons Medical Communications
  • Sirion Therapeutics, Inc.

Registry information

Official study title

A Randomized, Masked Multi-center Safety & Efficacy Study of the Effects of Preoperative & Postoperative Cataract Surgery Use of Difluprednate Ophthalmic Emulsion, 0.05% Compared to Prednisolone Acetate Ophthalmic Suspension 1% on Visual Acuity & Corneal Edema.

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 19, 2010
Registry last updated
Aug 8, 2012

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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