Topical Bromfenac for Intraoperative Miosis and Pain Redu... | NCT03831984

Studies
Topical Bromfenac for Intraoperative Miosis and Pain Reduction

NCT03831984

Sponsor

Hospital de La Luz

Status

Unknown status

Last Update Posted

Feb 6, 2019Actual

Enrollment

60Actual

Phase

Phase 4

Conditions

Cataract

Interventions

0,09% Bromfenac
0,1% sodium hyaluronate

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2018Actual

Primary Completion Date

Nov 30, 2018Actual

Completion Date

Mar 30, 2019Estimated

First Submitted Date

Feb 4, 2019

First Submission Date that Met QC Criteria

Feb 4, 2019

First Posted Date

Feb 6, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2019

Last Update Posted Date

Feb 6, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

This prospective cross-sectional randomized clinical study included 60 patients with senile cataract in the absence of significant ocular comorbidity. The patients received 0.09% bromfenac ophthalmic solution or control placebo twice a day for 3 days before surgery. Pupil diameter was measured at the initiation and finalization of femtosecond laser-assisted cataract surgery and pain quantification was assessed by analogous pain scale at one day follow-up.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
0,09% Bromfenac	Drug	topical 0,09% Bromfenac, one drop twice daily 3 days before surgery	0,09% Bromfenac

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
intraoperative miosis	Evaluation of reduction of intraoperative miosis before and after femtosecond laser assisted cataract surgery	2 days

Secondary Outcomes

Measure	Description	Time Frame
postoperative pain	Evaluation of reduction of postoperative pain using a visual analogue scale	1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
MARIA AGUILAR SIERRA, MD	FELLOWSHIP	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maria Camila Aguilar Sierra		Mexico City		06030	Mexico

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002386	Cataract

Ancestor Terms

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided