NCT01853072

Brief Summary

The purpose of this study is to demonstrate superiority of Nepafenac Ophthalmic Suspension, 0.3% dosed once daily relative to Nepafenac Vehicle based upon clinical outcomes among diabetic subjects following cataract surgery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
881

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2013

Status
completed

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

May 10, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2013

Completed
18 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

August 3, 2016

Completed
Last Updated

August 3, 2016

Status Verified

June 1, 2016

Enrollment Period

1.9 years

First QC Date

May 10, 2013

Results QC Date

May 13, 2016

Last Update Submit

June 23, 2016

Conditions

Non-Proliferative Diabetic RetinopathyCataract

Keywords

Diabetes Type IDiabetes Type IInon-proliferative diabetic retinopathymacular edemaCataract

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90

    BCVA (with spectacles or other visual corrective devices) was reported in letters read correctly, using the Early Treatment Diabetic Retinopathy Study (ETDRS) test of 70 letters. Improvement of BCVA was defined as an increase (gain) in the number of letters read, compared to the baseline assessment. One eye (study eye) contributed to the analysis.

    Baseline to Day 14, and maintained through Day 90

  • Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)

    Macular edema was defined as ≥ 30% Increase from pre-operative baseline in central subfield macular thickness, as measured with Spectral Domain Ocular Coherence Tomography (SD-OCT). One eye (study eye) contributed to the analysis.

    Day 0 to Day 90

Secondary Outcomes (4)

  • Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90

    Baseline to Day 90

  • Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60

    Baseline to Day 60

  • Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit [Time Frame: Day 7 up to Any Visit]

    Day 7 up to any visit through Day 90

  • Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit

    Day 7 up to any visit through Day 90

Study Arms (2)

Nepafenac

EXPERIMENTAL

With prednisolone acetate standard of care, Nepafenac Ophthalmic Suspension, 0.3%, 1 drop instilled in the operative eye 1 day prior to surgery, continuing on the day of surgery, and for 90 days following surgery. An additional 1 drop will be administered 30 to 120 minutes prior to surgery.

Drug: Nepafenac Ophthalmic Suspension, 0.3%Drug: Prednisolone acetate

Vehicle

PLACEBO COMPARATOR

With prednisolone acetate standard of care, Nepafenac vehicle, 1 drop instilled in the operative eye 1 day prior to surgery, continuing on the day of surgery, and for 90 days following surgery. An additional 1 drop will be administered 30 to 120 minutes prior to surgery.

Other: Nepafenac vehicleDrug: Prednisolone acetate

Interventions

Nepafenac Ophthalmic Suspension, 0.3%DRUG

Test intervention

Also known as: Nepafenac
Nepafenac
Nepafenac vehicleOTHER

Inactive ingredients used as placebo comparator

Vehicle
Prednisolone acetateDRUG

1 drop instilled in the operative eye 4 times daily beginning post-operatively on the day of surgery for the first 2 weeks, followed by 2 times daily for the next 2 weeks

Also known as: Omnipred™, Prednisolone acetate ophthalmic suspension
NepafenacVehicle

Eligibility Criteria

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

You may qualify if:

  • Planned cataract extraction by phacoemulsification with implantation of a posterior chamber intraocular lens;
  • History of Type 1 or 2 diabetes and non-proliferative diabetic retinopathy (NPDR) (mild, moderate, or severe) in the study eye;
  • Best corrected visual acuity (BCVA) of 73 letters or worse in the study eye with expectation of improvement after surgery;
  • Understand and sign an informed consent document;

You may not qualify if:

  • Pre-existing macular edema in the study eye;
  • History in the study eye of retinal detachment, wet age-related macular degeneration, chronic or recurrent inflammatory eye disease, or prior procedures;
  • Planned cataract surgery in the fellow eye after randomization and prior to the Day 90 postoperative study visit or through study exit;
  • Planned multiple procedures for the study eye during the cataract/intraocular lens implantation surgery;
  • Participation in any other clinical study within 30 days of the screening visit;
  • Females of childbearing potential who are breast feeding, have a positive urine pregnancy test at screening, are not willing to undergo a urine pregnancy test upon entering or exiting the study, intend to become pregnant during the study, or do not agree to use adequate birth control methods for the duration of the study;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

CataractDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2Macular Edema

Interventions

nepafenacprednisolone acetateMethylprednisolone

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesMacular DegenerationRetinal DegenerationRetinal Diseases

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Therapeutic Unit Head, Cornea and Inflammation
Organization
Alcon Research, Ltd.
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • Clinical Project Lead GCRA, Pharma

    Alcon Research

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2013

First Posted

May 14, 2013

Study Start

June 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

August 3, 2016

Results First Posted

August 3, 2016

Record last verified: 2016-06