NCT01193504

Brief Summary

The purpose of this study is to determine if Lotemax eye drops are at least as effective as Pred Forte eye drops, which are the standard of care after cataract surgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2010

Typical duration for phase_4

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2010

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

June 14, 2012

Status Verified

June 1, 2012

Enrollment Period

2.1 years

First QC Date

August 31, 2010

Last Update Submit

June 13, 2012

Conditions

PseudophakiaCataract Surgery

Keywords

Prevention of Retinal Thickening and CME Following PhacoemulsificationPseudophakia following cataract surgery

Outcome Measures

Primary Outcomes (1)

  • Prevention Of Retinal Thickening

    * OCT (optical coherence tomography) with macular thickening * Incidence of CME ( cystoids macular edema) * BCVA (best corrected visual acuity) * UCVA (uncorrected visual acuity) * Central corneal thickness

    1 Year

Study Arms (2)

Pred Forte

ACTIVE COMPARATOR

Patients scheduled to undergo phacoemulsification will be randomized in a 1:1 schedule to receive Pred Forte BID for 4 weeks postop. All patients will receive Xibrom BID for one month and Besifloxacin BID for 7 to 10 days postop.

Drug: Pred Forte

Lotemax

ACTIVE COMPARATOR

patients scheduled to undergo phacoemulsification will be randomized in a 1:1 schedule to receive Lotemax BID for 4 weeks postop. All patients will receive Xibrom BID for one month and Besifloxacin BID for 7 to 10 days postop.

Drug: Lotemax

Interventions

Pred ForteDRUG

Pred Forte BID for 4 weeks postop

Pred Forte
LotemaxDRUG

Lotemax BID for 4 weeks postop.

Lotemax

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female \>18 years of age scheduled to undergo cataract surgery
  • Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (e.g. diabetics with normal retinal exams)
  • Expected visual outcome of BCVA (best corrected visual acuity)\> 20/25 postoperatively, as determined by potential visual acuity testing and review of preoperative corneal topography and OCT (optical coherence tomography).
  • Ability to provide informed consent, take study medications as directed, and likely to complete all study visits

You may not qualify if:

  • Known contraindication to any study medication or any of their components
  • Required use of ocular medications other than the study medications during the study
  • Evidence of macular disease (Epiretinal membrane, Vitreomacular traction syndrome, macular hole) on preoperative OCT (optical coherence tomography)
  • Presence of significant dry macular degeneration that may impact postoperative visual results.
  • History of retinal vein occlusion or diabetic macular edema, uveitis or any macular disease predisposing them to cystoid macular edema or prolonged intraocular inflammation.
  • Posterior capsule rupture, Vitreous loss during surgery or any other complication that in the surgeon's opinion, could reduce potential for targeted visual outcome
  • Anticipated need for mechanical iris dilating devices
  • Presence of Epithelial Basement Membrane Dystrophy, significant dry eye, significant blepharitis, or any other corneal condition that may impact BCVA (best corrected visual acuity) postoperatively

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Harvard Eye Associates

Laguna Hills, California, 92653, United States

RECRUITING

The Center For Excellence in Eye care

Miami, Florida, 33176, United States

RECRUITING

Ophthalmic Consultants of Boston

Waltham, Massachusetts, 02451, United States

COMPLETED

MeSH Terms

Conditions

Pseudophakia

Interventions

prednisolone acetateLoteprednol Etabonate

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • William Trattler, MD

    The Center for Excellence in Eye Care

    PRINCIPAL INVESTIGATOR

  • John Hovanesian, MD

    Harvard Eye Associates

    PRINCIPAL INVESTIGATOR

  • Bonnie Henderson, MD

    Ophthalmic Consultants of Boston

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenna Piel

CONTACT

(951)653-5566j.piel@imedsonline.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 31, 2010

First Posted

September 2, 2010

Study Start

September 1, 2010

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

June 14, 2012

Record last verified: 2012-06

Locations

US(3)