Trial | NCT04281862  Report issue

Title

DEXTENZA Compared to Topical Prednisolone in Patients Undergoing Bilateral LASIK Surgery
DEXTENZA Compared to Topical Prednisolone in Patients Undergoing Bilateral LASIK

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    20
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.
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.
Study Started
Jan 23
2020
Primary Completion
Apr 01
2020
Anticipated
Study Completion
May 01
2020
Anticipated
Last Update
Feb 24
2020

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

Group A Experimental

Dextenza

Group B Active Comparator

Topical Prednisolone

Criteria 

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
No Results Posted