Efficacy of Dextenza Insert in Upper vs Lower Punctum Following Cataract Surgery With PCIOL.

NCT05372315 | Completed Phase 4 Results FDA Drug

• 1 other identifier: SPENCER-2022-401
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) with or without iStent/Hydrus/Goniotomy when placed in the lower punctum compared to the upper punctum.

Conditions

Cataract

Keywords

PCIOL; CCI CE

Outcome Measures

Primary Outcomes (2)

• Participants With Complete Absence of Ocular Pain at Day 8

  Participant reported ocular pain on a scale of (0-10) with zero (0) equaling no pain and ten(10) equaling maximal pain on day 8.

  at Day 8

• Participants With Zero Cells on Day 14

  Proportion of of participants with complete absence of anterior chamber cell at Day 14 as measured by Summed Ocular Inflammation Score (0-4).

  at Day 14

Secondary Outcomes (2)

• Ease of Insertion

  Day 0

• Attempts to Achieve Successful Insertion

  Day 0

Study Arms (2)

Lower Punctum Insertion (Group 1)

OTHER

DEXTENZA (dexamethasone ophthalmic insert, 0.4mg) for intracanalicular use Group 1 (up to 40 eyes) will receive the insert in the lower punctum on the day of surgery in the OR.

Drug: Dextenza 0.4Mg Ophthalmic Insert

Upper Punctum Insertion (Group 2)

OTHER

DEXTENZA (dexamethasone ophthalmic insert, 0.4mg) for intracanalicular use Group 2 (up to 40 eyes) will receive the insert in the upper punctum on the of surgery in the OR.

Drug: Dextenza 0.4Mg Ophthalmic Insert

Interventions

Dextenza 0.4Mg Ophthalmic Insert DRUG

(dexamethasone ophthalmic insert)-for the treatment of ocular inflammation and pain following following ophthalmic surgery.

Lower Punctum Insertion (Group 1); Upper Punctum Insertion (Group 2)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will be eligible for study participation if they:
• Are planning to undergo non-complicated CCI CE/PCIOL in one or both eyes with or without iStent/Hydrus/Goniotomy.
• Are willing and able to comply with clinic visits and study related procedures.
• Are willing and able to sign the informed consent form.
• Not pregnant.

You may not qualify if:

• Subjects are not eligible for study participation if they:
• Are currently being treated with corticosteroid implant (i.e. Ozurdex).
• Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye.
• Have a history of complete punctal occlusion in one or both punctum.
• Currently use topical ophthalmic steroid medications.
• Are unwilling or unable to comply with the study protocol.
• Are determined by the Investigator to not be included for reasons not already specified (e.g., systemic, behavioral, or other ocular disease/abnormality) or if the health of the subject or the validity of the study outcomes may be compromised by the subject's enrollment.
• Have active infectious systemic disease.
• Have active infectious ocular or extraocular disease.
• Have unobstructed nasolacrimal duct in the study eye(s) (dacrocystitis).
• Have known hypersensitivity to dexamethasone or are a known steroid responder.
• Have a history of ocular inflammation or macular edema.
• Are currently being treated with immunomodulating agents in the study eye(s).
• Are currently being treated with immunosuppressants an/or oral steroids.
• Are Pregnant or breast-feeding or wish to become pregnant during the length of study participation.

Sponsors & Collaborators

• Iworks Laser and Vision Center: lead
• Ocular Therapeutix, Inc.: collaborator

Study Sites (1)

Iworks Laser & Vision Center

Dayton, Ohio, 45405, United States

Location

Related Publications (1)

• Greenwood MD, Gorham RA, Boever KR. A Randomized Fellow-Eye Clinical Trial to Evaluate Patient Preference for Dexamethasone Intracanalicular Insert or Topical Prednisolone Acetate for Control of Postoperative Symptoms Following Bilateral Femtosecond Laser in Site Keratomileusis (LASIK). Clin Ophthalmol. 2020 Aug 6;14:2223-2228. doi: 10.2147/OPTH.S265311. eCollection 2020.

  PMID: 32821083 BACKGROUND

MeSH Terms

Conditions

Cataract

Interventions

Calcium Dobesilate

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Dr. Patrick L. Spencer
• Organization: Iworks Laser and Vision Center

iworkeye@gmail.com

937-226-7870

Study Officials

• Patrick L Spencer, DO

  Iworks Laser & Vision Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Each subject's participation is expected to last for approximately 1 month and will be required to complete six scheduled visits over the course of the study period: Baseline (Screening Visit), Operative Visit/Insertion Day (Day 0), Day 1, Day 8, Day 14 and Day 30.

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 12, 2022
• Study Start: June 15, 2022
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: August 23, 2023
• Results First Posted: August 23, 2023

Record last verified: 2023-07

Locations

US (1)