Clinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface Staining

Alcon

Status: Completed

Conditions: Dry Eye Syndrome

Treatments: Other: OPTIVE® lubricating eyedrops; Other: Preservative-free saline solution eyedrops; Other: Systane® ULTRA lubricant eyedrops

Study type: Interventional

Funder types: Industry

Identifiers

NCT01863368

M-12-040

Details and patient eligibility

About

The purpose of this study is to compare Systane® ULTRA lubricant eye drops to OPTIVE® lubricating eye drops for ocular surface staining within dry eye subjects and to evaluate the safety of Systane® ULTRA after 3 months of use.

Full description

Following a 2-week washout phase with saline eye drops, subjects were randomized to receive either Systane® ULTRA or OPTIVE® for the remainder of the study.

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Willing and able to attend all study visits.
• Diagnosis of dry eye, as specified in protocol.
• Uses artificial tears, as specified in protocol.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Poor visual acuity, as specified in protocol.
• Women of childbearing potential who are pregnant, lactating, or not using adequate birth control, as specified in protocol.
• Any hypersensitivity or allergy to the investigational products or ingredients.
• Any eye disorder, ocular surgery, medication, medical condition, or systemic disease, as specified in protocol.
• Contact lens use within 2 weeks of Screening Visit.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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105 participants in 2 patient groups

Systane Ultra

Experimental group

Description:

Systane® ULTRA lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).

Treatment:

Other: Preservative-free saline solution eyedrops

Other: Systane® ULTRA lubricant eyedrops

Optive

Active Comparator group

Description:

OPTIVE® lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).

Treatment:

Other: OPTIVE® lubricating eyedrops

Other: Preservative-free saline solution eyedrops