Recruiting
Phase 1
Phase 2

NSAID, OMIDRIA, Triamcinolone

Sponsor:

Inder Paul Singh, M.D.

Code:

NCT06681688

Conditions

Cataract

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

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

Study Details

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

Study ID

NCT06681688

Start date

Jul 10, 2024

Status verified date

Nov, 2024

Completion date

Aug, 2025

Anticipated

Primary completion date

Jun, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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
  • Participants who do not meet the exclusion criteria may be enrolled.

Exclusion Criteria:

  • 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

Study Design

Enrollment

94 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Study Arm (OMIDRIA)

  • 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).

active comparator: Control Arm (Standard of Care)

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.

Interventions

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

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).

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

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%)

Primary outcome measure

  • inflammation [ Time Frame: 8 days ]

Central Contacts and Locations

Central contacts

Paul Singh, MD

262-637-0500ipsingh@amazingeye.com

Cathleen McCabe, MD

941-493-3763mccabe131@hotmail.com

Locations

The Eye Associates - Venice

Recruiting

Venice, Florida, United States, 34292

Contacts

Cathleen McCabe, MD

941-493-3763cmccabe131@hotmail.com

The Eye Centers of Racine & Kenosha

Recruiting

Racine, Wisconsin, United States, 53405

Contacts

Paul Singh, MD

262-637-0500ipsingh@amazingeye.com

More Information

Sponsor

Inder Paul Singh, M.D.

Last update posted

Nov 29, 2024

Last verified

Nov, 2024

Keywords

  • OMIDRIA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Inder Paul Singh, M.D. on 2024-11-29.