NCT01657266

Brief Summary

The purpose of this study is to evaluate efficacy and safety of the ophthalmic solution PRO-155 in patients post phacoemulsification.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

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

July 19, 2012

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 6, 2012

Completed
1.3 years until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

October 30, 2018

Completed
Last Updated

October 30, 2018

Status Verified

February 1, 2018

Enrollment Period

1.2 years

First QC Date

July 19, 2012

Results QC Date

June 14, 2016

Last Update Submit

February 8, 2018

Conditions

CataractPhacoemulsification Cataract Surgery

Keywords

bromfenacnepafenaccataractphacoemulsification cataract surgery

Outcome Measures

Primary Outcomes (2)

  • Percentage of Cellularity in Anterior Chamber

    Change from Percentage of Cellularity in anterior chamber after 30 days of treatment.

    day 30

  • Flare in Anterior Chamber

    Percentage of Participants with flare in anterior chamber after 30 days of treatment

    day 30

Secondary Outcomes (2)

  • Percentage of Patients Without Ocular Pain

    day 30

  • Mean Aqueous Concentration of Intervention Drug

    before surgery

Other Outcomes (4)

  • Epithelial Defects Detected With Fluorescein

    measurements will be made at days 1, 5, 7 and 30

  • Epithelial Defects Detected With Green Lissamine

    measurements will be made at days 1, 5, 7 and 30

  • Intraocular Pressure

    day 30

  • +1 more other outcomes

Study Arms (2)

PRO-155

EXPERIMENTAL

Bromfenac 0.09% (0.9mg/mL) Ophthalmic solution Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye Maintenance therapy: 1 drop 3 times a day for 30 days

Drug: PRO-155

Nevanac

ACTIVE COMPARATOR

Nepafenac 0.1% (1mg/mL) Ophthalmic Suspension Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye Maintenance therapy: 1 drop 3 times a day for 30 days

Drug: Nevanac

Interventions

PRO-155DRUG

Pre-medication (before surgery) and maintenance treatment.

PRO-155
NevanacDRUG

Pre-medication (before surgery) and maintenance treatment.

Nevanac

Eligibility Criteria

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

You may qualify if:

  • Patients older than 18 years who require cataract surgery
  • Both genders
  • Provide informed consent
  • Normal Laboratory results

You may not qualify if:

  • Patients with visual acuity of 20/40 or less in the contralateral eye of the surgery
  • Patients with any trans-surgical complication
  • Patients with a cataract \>NC4, C4 or P4 classified with the system LOCS
  • Patients with any active corneal pathology
  • Patients under any steroidal treatment (topic, systemic or inhaled)14 days prior surgery or NSAIDs 7 days before the surgery (except low-dose aspirin)
  • Patients with IOP \<5 or \>21 mmHg
  • Patients that have ocular pain, cellularity or flare at the moment of selection
  • Patients with ocular exfoliation, trauma or any inflammatory disease
  • Patients with diabetic retinopathy that need treatment or uncontrolled diabetes mellitus
  • Patients who are planning cataract surgery of the contralateral eye 14 days after surgery of the study eye
  • Patients with history of hypersensitivity or contraindication for any drug used in the study
  • Patients under anticoagulant treatment
  • Contact lens users
  • Pregnant patients, at risk of pregnancy or breastfeeding
  • Patients without birth control treatment
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Jalisco, 44280, Mexico

Location

Related Links

MeSH Terms

Conditions

Cataract

Interventions

nepafenac

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Limitations and Caveats

The study was performed according to the clinical protocol.

Results Point of Contact

Title
Leopoldo M Baiza-Duran MD, Clinical trials Director
Organization
Laboratorios Sophia S.A. de C.V.
leopoldo.baiza@sophia.com.mx
52+ (33) 30 01 42 00

Study Officials

  • Leopoldo M. Baiza-DurĂ¡n, MD

    Laboratorios Sophia S.A de C.V.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2012

First Posted

August 6, 2012

Study Start

December 1, 2013

Primary Completion

March 1, 2015

Study Completion

April 1, 2015

Last Updated

October 30, 2018

Results First Posted

October 30, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

The personal data were collected and analyzed according to confidentiality policy.

Locations

ME(1)