Study of Complication Rates in Cataract Surgery Patients Treated With Combined Pre-operative NSAID, OMIDRIA, and Subconjunctival Triamcinolone Acetonide Compared With Peri-operative SOC

NCT06681688 | Recruiting Phase 1 FDA Drug

• 1 other identifier: MSS V2 6324
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 2

Brief Summary

This is a multicenter, 2-arm, randomized, prospective study of patients slated for bilateral cataract extraction. One eye will be randomized to the Study Arm, and the fellow eye will be randomized to the Control Arm.

Conditions

Cataract

Keywords

OMIDRIA

Outcome Measures

Primary Outcomes (1)

• inflammation

  The proportion of participants with inflammation on Day 8. (Participants will be considered to have no inflammation (Grade 0) if they have ≤ 2 anterior chamber cells and are asymptomatic.) {Anterior Inflammation Scale, 0-4 with 4 being the worst or most severe score}

  8 days

Secondary Outcomes (1)

• SPEED Questionnaire

  30 days

Study Arms (2)

Study Arm (OMIDRIA)

EXPERIMENTAL

* Pre-op, 1 drop ketorolac (0.5%) {Toradol}, 1 drop moxifloxacin (0.5%) {Avelox} * Prior to surgery: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%) * Concl. of surgery while still in the OR: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%) {Pred Forte} * Post-op recovery: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%). Intraoperative interventions: intracameral phenylephrine {Sudafed} 1.0%/ketorolac 0.3%, {OMIDRIA} intracameral moxifloxacin (0.5%), and subconjunctival triamcinolone acetonide (0.4 mL, 10 mg/mL) {Kenalog}. In-office drops administered by study staff at the end of the 1-day visit: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%). Rescue therapy will be allowed, if necessary, at the discretion of the evaluating physician and will consist of prednisolone acetate (1%) QID (taper also at the discretion of the evaluating physician).

Drug: Omidria, {0.3%-1% Intraocular Solution}, VIGAMOX {0.5% moxifloxacin hydrochloride}, Kenalog {0.4 ml, 10mg/ml, triamcinolone acetonide}

Control Arm (Standard of Care)

ACTIVE COMPARATOR

Self-administration of: Ketorolac (0.5%) {Toradol} four times daily (QID) x 1 day and moxifloxacin (0.5%) {Avelox} drops three times daily (TID) x 1 day before SX. On the Day of SX, eyes will receive in-office drops administered by study staff according to the following: * In pre-operative holding: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%) * Immediately prior to SX: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%) * At the conclusion of SX while still in the operating room: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%) Pred Forte} * Any time in post-op recovery: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%). Eyes will then self-administer the following postoperative interventions: ketorolac drops QID x 1 month. Prednisolone acetate tapering QID x1 week, TID x 1 week, twice daily (BID) x 1 week, and once daily (QD) x 1 week; and moxifloxacin drops TID x 1 week.

Drug: Ketorolac (0.5%) {Toradol}, moxifloxacin (0.5%) {VIGAMOX}, prednisolone acetate (1%) {Pred Forte}

Interventions

Omidria, {0.3%-1% Intraocular Solution}, VIGAMOX {0.5% moxifloxacin hydrochloride}, Kenalog {0.4 ml, 10mg/ml, triamcinolone acetonide} DRUG

Eyes in the Study Arm will be treated with the following intraoperative interventions: Intracameral (OMIDRIA) phenylephrine 1.0%/ketorolac 0.3%, intracameral moxifloxacin (0.5%), and subconjunctival triamcinolone acetonide (0.4 mL, 10mgs/mL).

Also known as: (OMIDRIA), Phenylephrine (1%) and Ketorolac (0.3%) intraocular solution

Study Arm (OMIDRIA)

Ketorolac (0.5%) {Toradol}, moxifloxacin (0.5%) {VIGAMOX}, prednisolone acetate (1%) {Pred Forte} DRUG

On the Day of Surgery, eyes in the Control Arm will receive in-office drops administered by study staff according to the following schedule: * In pre-operative holding: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%) * Immediately prior to surgery: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%) * At the conclusion of surgery while still in the operating room: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%) * Any time in postoperative recovery: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%)

Also known as: TORADOL (Generic), Vigamox, Avalox, Pred Forte, Prelone, Omnipred

Control Arm (Standard of Care)

Eligibility Criteria

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

You may qualify if:

• Adult participants \> 18 years of age undergoing bilateral cataract surgery
• Able to provide written informed consent prior to any study related procedure
• Able and willing, as assessed by the Investigator, to follow study instructions, complete study assessments, comply with the protocol, and attend study visits for the duration of the study
• Patients deemed to be "higher risk" for postoperative complications (e.g., well-controlled diabetes (HbA1c ≤7.0), history of uveitis, history of retinal vein occlusion, history of epiretinal membrane, history of vitreomacular traction, evidence of posterior synechiae, etc.) MAY be enrolled provided there has been no evidence of active disease or treatment in the prior 12 months

You may not qualify if:

• Cataract surgery combined with any other procedure (e.g., glaucoma, retina, etc.)
• Glaucoma patients or known steroid responders
• Oral anti-inflammatory medications to treat a systemic disease (exceptions to this include 81 mg aspirin, ibuprofen for headache, etc.)
• Intraocular injection within 6 months
• Any prior ocular implant
• Diagnosis of retinal thickening in the study eye within 12 months of enrollment
• Inability to provide informed consent
• Participation in another clinical trial

Sponsors & Collaborators

• Inder Paul Singh, M.D.: lead
• The Eye Associates: collaborator

Study Sites (2)

The Eye Associates - Venice

Venice, Florida, 34292, United States

RECRUITING

The Eye Centers of Racine & Kenosha

Racine, Wisconsin, 53405, United States

RECRUITING

MeSH Terms

Conditions

Cataract

Interventions

Triamcinolone Acetonide; Phenylephrine; Ketorolac; Ketorolac Tromethamine; Moxifloxacin; prednisolone acetate; Drugs, Generic; Methylprednisolone

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Pharmaceutical Preparations; Prednisolone; Pregnadienetriols

Study Officials

• Paul Singh, MD

  The Eye Centers of Racine & Kenosha

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Singh, MD

CONTACT

262-637-0500; ipsingh@amazingeye.com

Cathleen McCabe, MD

CONTACT

941-493-3763; mccabe131@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The biostatistician analyzing the data will be masked to both treatment arm and surgery center. When the Investigators or Sponsor look at the data, they will also be masked to treatment arm and surgery center.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a 2-arm non-inferiority trial with the following arms: * Control arm: Participants undergoing cataract surgery using conventional standard of care peri-operative eyedrops. * Study arm: Participants undergoing cataract surgery with a regimen of peri-operative topical eyedrops administered to the participant by study staff, in combination with intracameral phenylephrine 1.0%/ketorolac 0.3%, subconjunctival triamcinolone acetonide, and intracameral moxifloxacin.

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 8, 2024
• Study Start: July 10, 2024
• Primary Completion: June 1, 2025
• Study Completion: August 1, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)