NCT02816905

Brief Summary

This study aims to compare the effects of topical (Rimexolone versus Dexamethasone) on the IOP in children under 13 years of age who underwent bilateral strabismus surgery, and to compare the effects of topical (Rimexolone versus Fluorometholone) on the IOP in the children under 13 years of age who underwent bilateral strabismus surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_4

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
Last Updated

June 29, 2016

Status Verified

June 1, 2016

Enrollment Period

8 months

First QC Date

June 26, 2016

Last Update Submit

June 26, 2016

Conditions

Intraocular Pressure

Keywords

intraocular pressuretopical steroidsstrabismus

Outcome Measures

Primary Outcomes (1)

  • Measuring the rise in intraocular pressure using the Tono-Pen® after topical steroids are used in children under 12 years of age, who underwent bilateral strabismus surgery

    Measuring the rise in intraocular pressure using the Tono-Pen® after topical steroid use in children. IOP will be measured at postoperative weeks 1, 2, 3, 4 and 6. And will be compared with pre-operative values.

    IOP will be followed up for 6 weeks after initial use

Study Arms (3)

Group A

ACTIVE COMPARATOR

20 eyes that received topical 0.1% Dexamethasone 4 times per day for 2 weeks after surgery. And topical Moxifloxacin 4 times per day for 2 weeks after surgery.

Drug: 0.1 % Dexamethasone

Group B

ACTIVE COMPARATOR

20 eyes that received topical 0.1 % Fluorometholone 4 times per day for 2 weeks after surgery. And topical Moxifloxacin 4 times per day for 2 weeks after surgery.

Drug: 0.1% Fluorometholone

Group C

ACTIVE COMPARATOR

40 eyes that received topical 1% Rimexolone 4 times per day for 2 weeks after surgery. And topical Moxifloxacin 4 times per day for 2 weeks after surgery.

Drug: 1% Rimexolone

Interventions

0.1 % DexamethasoneDRUG

20 eyes are randomized to receive topical 0.1% Dexamethasone four times per day for 2 weeks.

Also known as: Topical steroid
Group A
0.1% FluorometholoneDRUG

20 eyes are randomized to receive topical 0.1% Fluorometholone four times per day for 2 weeks.

Also known as: Topical steroid
Group B
1% RimexoloneDRUG

40 eyes are randomized to receive topical 1% Rimexolone four times per day for 2 weeks. 20 of these eyes were the contralateral eyes of the patients who received 0.1% Dexamethasone in their first eye. The other 20 eyes were the contralateral eyes of the patients who received 0.1% Fluorometholone in their first eye

Also known as: Topical steroid
Group C

Eligibility Criteria

AgeUp to 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children younger than 13 years of age.
  • Children who underwent bilateral recession strabismus surgeries.
  • Preoperative IOP of 21.00 mmHg or less, with a cup-disc ratio of 0.3 or less.
  • The absence of systemic disease and ocular disease (apart from strabismus) in both eyes.
  • Children who can comply with the IOP measurements using the Tono-Pen®, as no type of anesthesia will be used, except for the topical anesthesia.

You may not qualify if:

  • Patients that are 13 years of age or older.
  • Children who need resection muscle surgeries, surgeries for the vertical, or the oblique muscles.
  • Preoperative IOP of more than 21.00 mmHg, or a cup-disc ratio of more than 0.3
  • Family history of glaucoma or high myopia.
  • A history of steroid usage in the past year.
  • Failure to comply with IOP measurements or the follow-up schedule.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University Hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Strabismus

Interventions

DexamethasoneSteroidsFluorometholonerimexolone

Condition Hierarchy (Ancestors)

Ocular Motility DisordersCranial Nerve DiseasesNervous System DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedPregnadienediols

Study Officials

  • Omar M. El Shafie El Zawahry, PhD

    Cairo University Hospital- Department of Ophthalmology

    STUDY CHAIR

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
Doctor Abeer Tawfik Farhan Al Hanaineh

Study Record Dates

First Submitted

June 26, 2016

First Posted

June 29, 2016

Study Start

October 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

June 29, 2016

Record last verified: 2016-06

Locations

EG(1)