NCT04281862

DEXTENZA Compared to Topical Prednisolone in Patients Undergoing Bilateral LASIK Surgery

DEXTENZA Compared to Topical Prednisolone in Patients Undergoing Bilateral LASIK

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Vance Thompson Vision · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To determine patient preference and treatment outcomes with an intracanalicular dexamethasone (0.4mg) insert compared to standard steroid drop regimen in the contralateral eye following bilateral LASIK surgery.

Detailed description

This prospective, open-label, single-center, randomized, investigator-sponsored clinical study seeks to investigate the outcomes of patients undergoing bilateral LASIK surgery with the treatment of a dexamethasone intracanalicular insert compared to standard of care topical prednisolone. All eyes will receive treatment. Additionally, all eyes will receive topical moxifloxacin QID for 1 week. Twenty patient eyes undergoing bilateral LASIK surgery will be randomized to receive either Dextenza (Group A) OR standard of care prednisolone acetate 1% QID for 1 week, BID for 1 week (Group B). The contralateral eye will receive treatment with either DEXTENZA or topical prednisolone as a comparator based on randomization of first eye to Group A or Group B. Post-operative evaluations will be performed on Day 1, Day 7, and Month 1 following surgery.

Conditions

• Refractive Surgery

Interventions

Type	Name	Description
DRUG	Dextenza 0.4Mg Ophthalmic Insert	The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion. The attributes of the insert reduce the risks for improper corticosteroid tapering and unwanted peaks and troughs in drug concentration.
DRUG	Topical Prednisolone	Standard of care topical drop treatment

Timeline

• Start date: 2020-01-23
• Primary completion: 2020-04-01
• Completion: 2020-05-01
• First posted: 2020-02-24
• Last updated: 2020-02-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study