NCT03831984

Brief Summary

To evaluate the effect of bromfenac ophthalmic solution 0.09% for reduction of intraoperative miosis and pain in patient who have undergone femtosecond laser-assisted 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
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

March 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 6, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2019

Completed
Last Updated

February 6, 2019

Status Verified

February 1, 2019

Enrollment Period

9 months

First QC Date

February 4, 2019

Last Update Submit

February 4, 2019

Conditions

Cataract

Keywords

Phacoemulsificationfemtosecond laserbromfenacNSAIDpupil

Outcome Measures

Primary Outcomes (1)

  • intraoperative miosis

    Evaluation of reduction of intraoperative miosis before and after femtosecond laser assisted cataract surgery

    2 days

Secondary Outcomes (1)

  • postoperative pain

    1 day

Study Arms (2)

0,09% Bromfenac

ACTIVE COMPARATOR

Topical 0,09% Bromfenac twice daily 3 days before surgery

Drug: 0,09% Bromfenac

0,1% sodium hyaluronate

PLACEBO COMPARATOR

Topical 0,1% sodium hyaluronate twice daily 3 days before surgery

Drug: 0,1% sodium hyaluronate

Interventions

0,09% BromfenacDRUG

topical 0,09% Bromfenac, one drop twice daily 3 days before surgery

Also known as: Zebesten
0,09% Bromfenac
0,1% sodium hyaluronateDRUG

topical 0,1% sodium hyaluronate, one drop twice daily 3 days before surgery

Also known as: Hyabak
0,1% sodium hyaluronate

Eligibility Criteria

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

You may qualify if:

  • Male and female
  • Subjects 18 years or older
  • Patients scheduled for unilateral femtosecond laser-assisted cataract surgery cataract surgery with posterior chamber (PC) IOL implantation.

You may not qualify if:

  • Presence of corneal abnormalities
  • History of intraocular surgery
  • History of ocular or systematic diseases (glaucoma, diabetes, uveitis
  • Regular, systemic use of steroid or NSAIDs during the previous 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maria Camila Aguilar Sierra

Mexico City, 06030, Mexico

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • MARIA AGUILAR SIERRA, MD

    FELLOWSHIP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 4, 2019

First Posted

February 6, 2019

Study Start

March 1, 2018

Primary Completion

November 30, 2018

Study Completion

March 30, 2019

Last Updated

February 6, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)