Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01001806
Other study ID # 2009-0199
Secondary ID
Status Completed
Phase Phase 4
First received October 23, 2009
Last updated August 26, 2011
Start date October 2009
Est. completion date January 2010

Study information

Verified date August 2011
Source Bucci Laser Vision Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Approximately 126 subjects scheduled to undergo cataract surgery by phacoemulsification, will be randomized in an even allocation (1:1:1) to either Acuvail, Xibrom, or Nevanac. Subjects will be instructed to begin dosing the study medication in the operative eye the day before surgery and continue dosing on the day of surgery. Beginning one hour before surgery, 1 drop of study medication will be instilled by operating room staff approximately every 15 minutes for a total of 3 doses. At the designated time a paracentesis will be performed at the start of the cataract procedure and at least 0.15 cc of aqueous humor will be collected. The sample will be immediately stored on dry ice and shipped to a laboratory for analysis.


Recruitment information / eligibility

Status Completed
Enrollment 126
Est. completion date January 2010
Est. primary completion date December 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Subjects must be 18 years of age or older.

- Scheduled for cataract surgery by phacoemulsification.

- Subject must be willing to comply with all study requirements and be willing to give informed consent.

Exclusion Criteria:

- Any subject that has a history of uveitis or active iritis.

- Subject can have no previous eye surgery, with the exception of refractive surgery, but not within 6 months.

- No ocular use of prostaglandins within 2 weeks of surgery.

- Use of oral, injectable or topical ophthalmic steroids, nonsteroidal anti-inflammatory (NSAIDS) or immunosuppressants within 14 days prior to surgery.

- Contraindications to NSAIDS.

- Active ocular infection.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Ketorolac Tromethamine 0.45%
One drop BID the day before surgery and then 3 doses the day of surgery prior to surgery
bromfenac 0.09%
One day pre operative 1 drop BID then 3 doses pre op day of surgery
nepafenac 0.1%
One drop BID, 1 day pre operative and then 3 doses the day of surgery

Locations

Country Name City State
United States Bucci Laser Vision Institute Wilkes-Barre Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Frank A. Bucci, Jr., M.D. Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Peak Aqueous Penetration day 4 of treatment No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06005675 - User Acceptability Evaluation of Pseudophakic Patients Previously Implanted With the TECNIS Odyssey IOL
Active, not recruiting NCT01382641 - Show Improved Vision With the HOYA AF-1 Aspheric Intraocular Lens After Cataract Surgery Phase 4
Completed NCT01382823 - Laser Cataract Surgery With the Femtosecond Laser Technology Phase 4
Completed NCT05991960 - Evaluation of Real-World Data on the Performance of the TECNIS Odyssey™ IOL
Active, not recruiting NCT05574959 - Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens, Model DEN00V N/A
Completed NCT02492659 - Clinical Research of Femtosecond Laser-Assisted Cataract Surgery N/A
Completed NCT01279031 - Randomized Comparison of the Abbott WHITESTAR Signature System With Ellips Tranversal Ultrasound vs. the Alcon Infiniti With the Ozil Torsional Handpiece in Phacoemulsification: A Contralaterally-Controlled Trial Phase 4
Completed NCT00999492 - Selection of Aspheric Diffractive Multifocal Intraocular Lens (IOLS) Based on Corneal Wavefront Phase 4
Completed NCT01061463 - Occupational Cataracts and Lens Opacities in Interventional Cardiology : the O'CLOC Study N/A
Completed NCT01021761 - A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)in Patients Undergoing Phacoemulsification Phase 4
Completed NCT00542581 - Acrysof Toric SN60T3corneal Astigmatism Between 0.75 and 1.00 D. N/A
Completed NCT03708367 - A Post-Market Evaluation of LipiFlow Treatment in Cataract Surgery Practice N/A
Completed NCT05575063 - Clinical Investigation of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD) N/A
Recruiting NCT05531292 - PROOF-OF-CONCEPT STUDY FOR NEW INTRAOCULAR LENS, MODEL C0002 N/A
Completed NCT05058274 - Clinical Results of a Monofocal Aspheric Bitoric Intraocular Lens With Plate Haptics in Hyperopic Eyes (HIPER-AT-TORBI)
Completed NCT05053399 - Evaluation of the TECNIS Symfony® Toric Intraocular Lens N/A
Recruiting NCT02639845 - Eye Drop Application Monitor, Pilot Study N/A
Completed NCT01684007 - A Clinical Outcome Study of Two Multifocal Intraocular Lenses (IOL) in Cataract Patients N/A
Completed NCT00827073 - Comparison of Tetracaine 0.5% and Lidocaine 2% Jelly for Topical Phacoemulsification Cataract Surgery N/A
Completed NCT00405730 - Nepafenac 0.1% Eye Drops, Suspension Compared to Ketorolac Trometamol 0.5% Eye Drops, Solution and Placebo Phase 3