Recruiting

DEXTENZA vs. Prednisolone

Sponsor:

Vance Thompson Vision

Code:

NCT04281862

Conditions

Refractive Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Dextenza 0.4Mg Ophthalmic Insert

Topical Prednisolone

Study Details

Brief 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.

Conditions

Refractive Surgery

Study ID

NCT04281862

Start date

Jan 23, 2020

Status verified date

Feb, 2020

Completion date

May 1, 2020

Anticipated

Primary completion date

Apr 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Any adult patient who is planned to undergo bilateral LASIK surgery.
  • Refractive error between the 2 eyes of 2 Diopters or less
  • Willing and able to comply with clinic visits and study related procedures
  • Willing and able to sign the informed consent form

Exclusion Criteria:

  • Patients under the age of 18.
  • Patients who choose to have monovision after LASIK
  • Patients with corneal pathology that may interfere with LASIK outcomes
  • Patients who are pregnant (must be ruled out in women of child-bearing age with pregnancy test).
  • Active infectious ocular or systemic disease.
  • Patients with active infectious ocular or extraocular disease.
  • Patients actively treated with local or systemic immunosuppression including systemic corticosteroids.
  • Patients with known hypersensitivity to Dexamethasone.
  • Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator.
  • Patients with a history of ocular inflammation or macular edema.
  • Patients with allergy or inability to receive topical antibiotic.
  • Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) greater than 1,200 mg/day
  • Patients with a corticosteroid implant (i.e. Ozurdex).
  • Active or history of chronic or recurrent inflammatory eye disease in either eye
  • Ocular pain in either eye
  • Proliferative diabetic retinopathy in either eye
  • Significant macular pathology detected on macular optical coherence tomography evaluation at the screening visit in either eye
  • Laser or incisional ocular surgery during the study period and 6 months prior in either eye
  • History of cauterization of the punctum

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group A

Dextenza

active comparator: Group B

Topical Prednisolone

Interventions

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.

Topical Prednisolone

Standard of care topical drop treatment

Primary outcome measure

  • Patient Preference [ Time Frame: Through Month 1 (Day 28 +/- 3 days) ]
  • Patient Comfort [ Time Frame: Through Month 1 (Day 28 +/- 3 days) ]

Central Contacts and Locations

Locations

Vance Thompson Vision ND

Recruiting

W. Fargo, North Dakota, United States, 58078

Contacts

Sarah Thiede

701-566-5390sarah.thiede@vancethompsonvision.com

Jake Hutchison

701-566-5390jake.hutchison@vancethompsonvision.com

Principal Investigator:

Michael Greenwod, MD

More Information

Sponsor

Vance Thompson Vision

Last update posted

Feb 24, 2020

Last verified

Feb, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vance Thompson Vision on 2020-02-24.