DEXTENZA Compared to Topical Prednisolone in Patients Undergoing Bilateral LASIK Surgery

NCT04281862 | Unknown Phase 4 FDA Drug

• 1 other identifier: ATLAS2020
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Patient Preference

  As measured by COMTOL adapted survey.

  Through Month 1 (Day 28 +/- 3 days)

• Patient Comfort

  As measured by SPEED Questionnaire.

  Through Month 1 (Day 28 +/- 3 days)

Secondary Outcomes (3)

• Ocular Surface Health

  Through Month 1 (Day 28 +/- 3 days)

• Visual Outcomes

  Through Month 1 (Day 28 +/- 3 days)

• Ocular Pain

  Through Month 1 (Day 28 +/- 3 days)

Other Outcomes (3)

• Safety Endpoints

  Through Month 1 (Day 28 +/- 3 days)

• Safety Endpoints

  Through Month 1 (Day 28 +/- 3 days)

• Safety Endpoints

  Through Month 1 (Day 28 +/- 3 days)

Study Arms (2)

Group A

EXPERIMENTAL

Dextenza

Drug: Dextenza 0.4Mg Ophthalmic Insert

Group B

ACTIVE COMPARATOR

Topical Prednisolone

Drug: Topical Prednisolone

Interventions

Dextenza 0.4Mg Ophthalmic Insert DRUG

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.

Group A

Topical Prednisolone DRUG

Standard of care topical drop treatment

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vance Thompson Vision: lead

Study Sites (1)

Vance Thompson Vision ND

West Fargo, North Dakota, 58078, United States

RECRUITING

MeSH Terms

Interventions

Calcium Dobesilate; Prednisolone

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 24, 2020
• Study Start: January 23, 2020
• Primary Completion: April 1, 2020
• Study Completion: May 1, 2020
• Last Updated: February 24, 2020

Record last verified: 2020-02

Locations

US (1)