Investigation of Maintaining Visual Performance Achieved With Cyclosporine Therapy (IMPACT)

Allergan

Status and phase: Completed; Phase 4

Conditions: Dry Eye Syndromes

Treatments: Drug: cyclosporine 0.05% ophthalmic emulsion; Drug: carboxymethylcellulose-based lubricant eye drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT02121847

GMA-RES-014-001

Details and patient eligibility

About

This study will evaluate the safety and efficacy of cyclosporine 0.05% ophthalmic emulsion (Restasis®) in patients with dry eye disease.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of dry eye in both eyes
• Willing to use eye drops for dry eye symptoms

Exclusion criteria

• Anticipate wearing contact lenses during the study
• Laser-assisted in situ keratomileusis (LASIK) surgery within the past 12 months
• Any ocular and/or lid surgeries within the past 6 months
• Cataract surgery in either eye
• Current or anticipated use of temporary punctal plugs during the study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

cyclosporine 0.05% ophthalmic emulsion

Experimental group

Description:

Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.

Treatment:

Drug: carboxymethylcellulose-based lubricant eye drops

Drug: cyclosporine 0.05% ophthalmic emulsion