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Ketorolac Plus Tobramycin/Dexamethasone Versus Tobramycin/Dexamethasone After Uneventful Phacoemulsification Surgery

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ClinicalTrials.gov Identifier: NCT01103401
Recruitment Status : Completed
First Posted : April 14, 2010
Last Update Posted : April 15, 2015
Sponsor:
Information provided by:
Veroia General Hospital

Brief Summary:

This randomized controlled trial compares two regimens of topical therapy:

  • tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day
  • combination of tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day, plus Ketorolac tromethamine 0.5% (Acular®, Allergan), one drop three times/day.

Patients are independently assessed by two ophthalmologists. On days 7,14,21,28 patients are evaluated for

  • corneal edema
  • conjunctival hyperemia
  • anterior chamber (Tyndall) reaction.

The investigators purpose was to evaluate the benefit of adding a non-steroid agent to an antibiotic/steroid combination after uneventful phacoemulsification. Adopting a weekly follow-up, to gain insight into the optimal duration of postoperative treatment and to examine whether risk factors for inflammation exist.


Condition or disease Intervention/treatment Phase
Cataract Drug: Drug: Tobramycin 0.3% - Dexamethasone 0.1% Drug: Drug: Tobramycin-Dexamethasone plus Ketorolac tromethamine Not Applicable

Detailed Description:
Patients were randomized to: i) tobramycin 0.3% - dexamethasone 0.1% one drop qid (TD group, n=72, 28 days) and ii) combination of tobramycin 0.3% - dexamethasone 0.1%, one drop qid, plus Ketorolac tromethamine 0.5%, one drop tid (TD-K group, n=73, 28 days). Patients undergoing vitrectomy due to posterior capsule rupture were excluded. On days 7, 14, 21, 28, the frequency of inflammation-related signs [corneal edema, conjunctival hyperemia, anterior chamber (Tyndall) reaction], as well as the best corrected visual acuity (BCVA) were measured. On day 21, logistic regression was performed to evaluate risk factors for inflammation.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Ketorolac Plus Tobramycin/Dexamethasone vs. Tobramycin/Dexamethasone After Uneventful Phacoemulsification Surgery
Study Start Date : October 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010


Arm Intervention/treatment
Active Comparator: Tobramycin/Dexamethasone Drug: Drug: Tobramycin 0.3% - Dexamethasone 0.1%
one drop four times per day
Other Name: Tobradex
Drug: Drug: Tobramycin-Dexamethasone plus Ketorolac tromethamine
Tobramycin-Dexamethasone one drop four times per day and Ketorolac tromethamine one drop three times per day
Other Name: Acular
Active Comparator: Tobramycin/Dexamethasone plus Ketorolac tromethamine Drug: Drug: Tobramycin 0.3% - Dexamethasone 0.1%
one drop four times per day
Other Name: Tobradex
Drug: Drug: Tobramycin-Dexamethasone plus Ketorolac tromethamine
Tobramycin-Dexamethasone one drop four times per day and Ketorolac tromethamine one drop three times per day
Other Name: Acular



Primary Outcome Measures :
  1. Visual acuity, corneal edema, Tyndall reaction, redness [ Time Frame: 1,7,14,28 post-operative day, Up to 28 days ]


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Ages Eligible for Study:   55 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • phacoemulsification (due to cataract)
  • uneventful phacoemulsification surgery

Exclusion Criteria:

  • history of intraocular surgery in the operated eye,
  • any previous episode of uveitis in the operated eye,
  • severe systemic disease (heart failure NYHA stage III of IV, end-stage renal failure, pulmonary failure, patients receiving chemotherapy),
  • regular, systemic use of steroid or non-steroid anti-inflammatory drugs during the last three months
  • disruption of the anterior lens capsule

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01103401


Sponsors and Collaborators
Veroia General Hospital
Investigators
Study Director: Leonidas E Papazisis, Director leopapazisis@yahoo.gr

Responsible Party: Department of Ophthalmology, Veroia General Hospital
ClinicalTrials.gov Identifier: NCT01103401     History of Changes
Other Study ID Numbers: VGH-EYE02
First Posted: April 14, 2010    Key Record Dates
Last Update Posted: April 15, 2015
Last Verified: April 2010

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Dexamethasone acetate
Dexamethasone
Ketorolac
Ketorolac Tromethamine
BB 1101
Tobramycin
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Anti-Bacterial Agents