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

Cataract Clinical Trial

— DEXTENZA  

Official title:

A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Treatment With an Intracanalicular Dexamethasone (0.4mg) Ophthalmic Insert in the Operating Room Following Cataract Surgery/Intraocular Lens Implant (IOL).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05372315
• Other study ID #: SPENCER-2022-401
• Status: Completed
• Phase: Phase 4
• Start date: June 15, 2022
• Est. completion date: October 31, 2022

Study information

• Verified date: July 2023
• Source: Iworks Laser and Vision Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a randomized, controlled study to evaluate 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

Subjects will be eligible for study participation if they:

1. Are planning to undergo non-complicated CCI CE/PCIOL in one or both eyes with or without iStent/Hydrus/Goniotomy.

2. Are willing and able to comply with clinic visits and study related procedures.

3. Are willing and able to sign the informed consent form.

4. Not pregnant.

Exclusion Criteria:

Subjects are not eligible for study participation if they:

1. Are currently being treated with corticosteroid implant (i.e. Ozurdex).

2. Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye.

3. Have a history of complete punctal occlusion in one or both punctum.

4. Currently use topical ophthalmic steroid medications.

5. Are unwilling or unable to comply with the study protocol.

6. 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.

7. Have active infectious systemic disease.

8. Have active infectious ocular or extraocular disease.

9. Have unobstructed nasolacrimal duct in the study eye(s) (dacrocystitis).

10. Have known hypersensitivity to dexamethasone or are a known steroid responder.

11. Have a history of ocular inflammation or macular edema.

12. Are currently being treated with immunomodulating agents in the study eye(s).

13. Are currently being treated with immunosuppressants an/or oral steroids.

14. Are Pregnant or breast-feeding or wish to become pregnant during the length of study participation.

Related Conditions & MeSH terms

• Cataract

Intervention

Drug:
• Dextenza 0.4Mg Ophthalmic Insert
(dexamethasone ophthalmic insert)-for the treatment of ocular inflammation and pain following following ophthalmic surgery.

Locations

Country	Name	City	State
United States	Iworks Laser & Vision Center	Dayton	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Iworks Laser and Vision Center	Ocular Therapeutix, Inc.

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Ease of Insertion	Rated as Easy, Moderate, Difficult	Day 0
Secondary	Attempts to Achieve Successful Insertion	Number of attempts to insert the dexamethasone insert in the upper or lower punctum.	Day 0