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Trial record 26 of 75 for:    PEELING SKIN SYNDROME

Bromfenac to Reduce Inflammation in Patients With Pseudoexfoliation Syndrome After Cataract Surgery (REPEX)

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ClinicalTrials.gov Identifier: NCT02137161
Recruitment Status : Completed
First Posted : May 13, 2014
Last Update Posted : October 29, 2014
Sponsor:
Information provided by (Responsible Party):
Arcispedale Santa Maria Nuova-IRCCS

Brief Summary:

OBJECTIVE To evaluate the efficacy of bromfenac ophthalmic solution 0.09% for reducing postoperative inflammation in eyes with pseudoexfoliation syndrome (PEX) undergoing cataract surgery and receiving standard postoperative eye drops (dexamethasone 0.1% plus tobramycin 0.3% ophthalmic solution).

DESIGN Two arms, parallel group, randomized, single center, prospective, phase IV clinical trial.

PARTICIPANTS Sixty-two subjects with PEX and cataract will be sequentially assigned, according to a computer-generated randomization list (1:1), to bromfenac (n = 31) or not (n = 31).

INTERVENTION Cataract surgery by means of phacoemulsification and implantation of posterior-chamber intraocular lens will be performed by two experienced ophthalmic surgeons.

Standard Arm: only a standard antibiotic and steroid ophthalmic suspension will be given starting the day after the surgery for two weeks, dosed QID for the first week and BID for the second week (dexamethasone 0.1% and tobramycin 0.3% eye drops association).

Experimental Arm: eyes will receive bromfenac BID for two weeks starting the day after surgery. Standard post-operative topical antibiotic and steroid will be also given concurrently, dosed QID for the first week and BID for the second week (dexamethasone 0.1% and tobramycin 0.3% eye drops association).

Measurements will be carried out at baseline and after one day, 3 days, 1 week and 4 weeks from cataract extraction.


Condition or disease Intervention/treatment Phase
Cataract Pseudoexfoliation Syndrome Drug: Dexamethasone+Tobramycin eye drop Drug: Bromfenac eye drop Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Reggio Emilia Study on Bromfenac for Patients With PseudoEXfoliation Syndrome Undergoing Cataract Surgery: the REPEX Study
Study Start Date : November 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014


Arm Intervention/treatment
Active Comparator: Dexamethasone+Tobramycin eye drop
An antibiotic and steroid eye drop association will be given starting the day after the surgery for two weeks, dosed QID for the first week and BID for the second week, to 31 patients.
Drug: Dexamethasone+Tobramycin eye drop
dexamethasone 0.1% and tobramycin 0.3% ophthalmic suspension

Experimental: Bromfenac
Bromfenac eye drops (BID for two weeks starting the day after surgery) plus an antibiotic and steroid eye drop association (QID for the first week and BID for the second week) will be given concurrently to 31 patients.
Drug: Dexamethasone+Tobramycin eye drop
dexamethasone 0.1% and tobramycin 0.3% ophthalmic suspension

Drug: Bromfenac eye drop
bromfenac ophthalmic solution 0.09%
Other Name: Yellox




Primary Outcome Measures :
  1. Change from baseline in anterior chamber inflammation measured by Laser Flare Photometry (photon counts per millisecond) [ Time Frame: Baseline, Day 3 ]
    Reduction of 30% of anterior chamber inflammation evaluated by Laser Flare Photometry (LFP) in the bromfenac arm when compared to the non-bromfenac arm at postoperative day 3.


Secondary Outcome Measures :
  1. Proportion of patients with central macular thickness greater than 300 microns [ Time Frame: Baseline, Week 4 ]
    Macular thickness will be evaluated by Spectral Domain Optical Coherence Tomography (SD-OCT).

  2. Proportion of subjects with best corrected visual acuity equal to 20/20 [ Time Frame: Baseline, Week 1 ]
  3. Proportion of patients who had no ocular pain [ Time Frame: Baseline, Day 3 ]


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • cataract
  • pseudoexfoliation syndrome

Exclusion Criteria:

  • history of ocular inflammation or trauma
  • previous intraocular surgery
  • corneal haze
  • retinal vascular disease
  • diabetic retinopathy
  • variation of the foveal profile at OCT (macular edema, epiretinal membrane)
  • moderate to severe age related macular degeneration

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): NCT02137161


Locations
Italy
Arcispedale Santa Maria Nuova IRCSS - Ophthalmology
Reggio Emilia, RE, Italy, 42123
Sponsors and Collaborators
Arcispedale Santa Maria Nuova-IRCCS
Investigators
Principal Investigator: Marco Coassin, MD PhD Arcispedale S. Maria Nuova IRCCS
Study Chair: Luigi Fontana, MD PhD Arcispedale S. Maria Nuova IRCCS

Responsible Party: Arcispedale Santa Maria Nuova-IRCCS
ClinicalTrials.gov Identifier: NCT02137161     History of Changes
Other Study ID Numbers: 2013-002066-39
First Posted: May 13, 2014    Key Record Dates
Last Update Posted: October 29, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Syndrome
Exfoliation Syndrome
Cataract
Disease
Pathologic Processes
Lens Diseases
Eye Diseases
Iris Diseases
Uveal Diseases
Dexamethasone acetate
Bromfenac
Dexamethasone
Tetrahydrozoline
BB 1101
Ophthalmic Solutions
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