DEXTENZA Compared to Topical Prednisolone in Patients Undergoing Bilateral LASIK Surgery

• Status: Recruiting
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vance Thompson Vision
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

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