NCT04711213

Brief Summary

Patients at least 40 years of age who are undergoing cataract surgery will be randomized to receive treatment with one of four groups of dexamethasone ophthalmic suspension or placebo eye drops to determine if the drops decrease inflammation and pain inside the eye and are safe after cataract surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2020

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

Study Start

First participant enrolled

September 14, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
Last Updated

January 15, 2021

Status Verified

September 1, 2020

Enrollment Period

2 months

First QC Date

September 23, 2020

Last Update Submit

January 12, 2021

Conditions

Cataract in Inflammatory Ocular Disorders

Outcome Measures

Primary Outcomes (1)

  • Ocular inflammation

    Measuring Anterior Cell Count

    Day 8

Secondary Outcomes (1)

  • Ocular Pain

    Day 8

Study Arms (4)

Dexamethasone Dose 1

ACTIVE COMPARATOR
Drug: Dexamethasone Dose 1

Dexamethasone Dose 2

ACTIVE COMPARATOR
Drug: Dexamethasone Dose 2

Placebo Dose 1

PLACEBO COMPARATOR
Drug: Placebo Dose 1

Placebo Dose 2

PLACEBO COMPARATOR
Drug: Placebo Dose 2

Interventions

Dexamethasone Dose 1DRUG

Dexamethasone ophthalmic suspension dose 1

Dexamethasone Dose 1
Dexamethasone Dose 2DRUG

Dexamethasone ophthalmic suspension dose 2

Dexamethasone Dose 2
Placebo Dose 1DRUG

Placebo suspension dose 1

Placebo Dose 1
Placebo Dose 2DRUG

Placebo suspension dose 2

Placebo Dose 2

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing traditional cataract surgery.

You may not qualify if:

  • Patients with unusual ocular conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre De. Oftalmologia

San Salvador, El Salvador

Location

Study Officials

  • Gabriel Casada, MD

    President - Centre De. Oftalmolgia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single Masked randomized study
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized to 2 active dosing groups and 2 corresponding dosing groups
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2020

First Posted

January 15, 2021

Study Start

September 14, 2020

Primary Completion

October 31, 2020

Study Completion

November 15, 2020

Last Updated

January 15, 2021

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

EL(1)