NCT03687931

Brief Summary

Patients at least 40 years of age who are undergoing cataract surgery will be randomized to receive treatment with one of two dose levels of dexamethasone ophthalmic suspension eye drops to determine if the drops decrease inflammation 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 P75+ for phase_1

Timeline
Completed

Started Aug 2018

Shorter than P25 for phase_1

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

August 26, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 26, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 27, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

May 24, 2019

Status Verified

May 1, 2019

Enrollment Period

6 months

First QC Date

September 26, 2018

Last Update Submit

May 23, 2019

Conditions

Inflammation Eye

Outcome Measures

Primary Outcomes (1)

  • Anterior Chamber Cell

    Number of cells in the anterior chamber

    30 days

Study Arms (2)

Arm 1

EXPERIMENTAL

Dexamethasone suspension dose level 1

Drug: Dexamethasone

Arm 2

EXPERIMENTAL

Dexamethasone suspension dose level 2

Drug: Dexamethasone

Interventions

DexamethasoneDRUG

Drop

Arm 1Arm 2

Eligibility Criteria

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

You may qualify if:

  • Male or female patients at least 40 years of age scheduled for unilateral cataract surgery by phacoemulsification with posterior chamber intraocular lens implantation.

You may not qualify if:

  • Patients who have received a periocular corticosteroid injection in the study eye in the 3 months prior to screening.
  • Patients who anticipate requiring treatment with any corticosteroids by any route, except inhalation, during the study.
  • Patients who are known steroid responders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona Eye Center

Chandler, Arizona, 85224, United States

Location

MeSH Terms

Conditions

Endophthalmitis

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Eye InfectionsInfectionsEye Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • William White

    iDrop, Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2018

First Posted

September 27, 2018

Study Start

August 26, 2018

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

May 24, 2019

Record last verified: 2019-05

Locations

US(1)