Effect of Intracameral Phenylephrine/Ketorolac on Intraoperative Pain

NCT04829799 | Withdrawn Phase 4 FDA Drug

• 2 other identifiers: IRB202002831 -AOCR40493
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare the effect of intraoperative intracameral Omidria (Phenylephrine and Ketorolac 1.0%/0.3%) verses 1% Lidocaine on pain reduction during and after cataract surgery.

Conditions

Pain Reduction

Outcome Measures

Primary Outcomes (1)

• Visual analog scale to measure pain

  Measurement of pain intensity by mean visual analog scale (VAS) pain scores from 0 (no pain) to 10 (extreme pain) during operation

  Day 1 of operation

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Subjects will receive intracameral 1% preservative-free lidocaine following paracentesis

Drug: 1% preservative-free lidocaine

Study Experimental Group

EXPERIMENTAL

Subject will receive Omidria (phenylephrine and ketorolac (1.0%/0.3%) added to the ophthalmic irrigating solution during the cataract extraction procedure

Drug: Phenylephrine 1.0%/ Ketorolac 0.3%

Interventions

1% preservative-free lidocaine DRUG

Instillation of intracameral lidocaine after initial paracentesis incision.

Control Group

Phenylephrine 1.0%/ Ketorolac 0.3% DRUG

Instillation of Omidria irrigation solution after paracentesis incision and in irrigation solution.

Study Experimental Group

Eligibility Criteria

• Age: 40 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with a cataract in the surgical eye

You may not qualify if:

• Patients that have previously exhibited sensitivities to acetylsalicylic acid, phenylacetic acid derivative, and other nonsteroidal anti-inflammatory drugs (NSAIDs)
• Those with a past medical history of asthma
• Those systemically using opioids or nonsteroidal anti-inflammatory drugs
• Those prescribed additional topical mydriatics, topical steroids, pilocarpine, or prostaglandins in the week preceding surgery
• Those with a history of alpha-1-adrenergic antagonist use
• Those with excisional, intraocular surgery in the planned surgical eye in the preceding year
• Those with a history of iris damage
• Those requiring iris expanding device or those with an acute or chronic uncontrolled eye condition, or those unable to effectively remember surgery or complete the post-operative assessment.
• Additionally, individuals less than 21 will be excluded.

Sponsors & Collaborators

• University of Florida: lead
• Omeros Corporation: collaborator

MeSH Terms

Interventions

Phenylephrine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• Eric Grieser, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

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: SPONSOR

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 2, 2021
• Study Start: February 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: June 13, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share