A Study of the Effect of Different Doses of Difluprednate Eye Drops on the Intraocular Pressure After Phacoemulsification

NCT05649111 | Unknown Phase 4

• 1 other identifier: 50-11-16
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims at detecting the minimum effective daily dose and duration of difluprednate that can be used to treat postoperative inflammation after phacoemulsification without increasing the intraocular pressure, and whether it can be safely given within the first 24 hours after the operation.

Conditions

Uveitis, Anterior

Outcome Measures

Primary Outcomes (1)

• Anterior chamber examination for flare and cell

  using SUN classification

  3 months

Study Arms (2)

Group A

ACTIVE COMPARATOR

will receive Difluprednate 4 times per day for 1 week, then twice per day for 1 week and then once per day for 5 days starting 24 hours after the operation

Drug: Difluprednate Eye Drops

Group B

ACTIVE COMPARATOR

will receive Difluprednate 3 times per day for 4 days, then twice per day for 4 days and then once per day for 4 days starting 4 hours after the operation

Drug: Difluprednate Eye Drops

Interventions

Difluprednate Eye Drops DRUG

post-operative cataract surgery medication regimen. but different dosages between the 2 groups.

Group A; Group B

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40-80
• Grade 1 to 4 nuclear cataract LOCS II
• Cumulative dissipated energy CDE 1 to 10
• Done by a single surgeon using the chopping technique

You may not qualify if:

• History of uveitis
• the use of topical or systemic steroids on the last post-operative day
• Intraoperative or postoperative complications
• Intraoperative iris manipulations or phaco traume

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, 33516, Egypt

RECRUITING

MeSH Terms

Conditions

Uveitis, Anterior

Condition Hierarchy (Ancestors)

Panuveitis; Uveitis; Uveal Diseases; Eye Diseases

Study Officials

• Ahmed Hashem, PhD

  Kafrelsheikh university faculty of medicin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Hashem, PhD

CONTACT

+201003828881; ahmed_hashiem@med.kfs.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of ophthalmology ,ophthalmology consultant

Model Details: * Group A (FDA dose): will receive Difluprednate 4 times per day for 1 week, then twice per day for 1 week and then once per day for 5 days starting 24 hours after the operation * Group B will receive Difluprednate 3 times per day for 4 days, then twice per day for 4 days and then once per day for 4 days starting 4 hours after the operation

Study Record Dates

• First Submitted: November 25, 2022
• First Posted: December 13, 2022
• Study Start: November 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: December 13, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)