A Safety and Effectiveness Study of a New Preservative Free Rewetting Drop

Bausch + Lomb

Status: Completed

Conditions: Contact Lens Wear

Treatments: Device: OPTI-FREE; Device: BL-300-PFM04

Study type: Interventional

Funder types: Industry

Identifiers

NCT04175340

952

Details and patient eligibility

About

The objective of this study is to evaluate the safety and effectiveness of lubricating and rewetting drop (Test) compared to OPTI-FREE® Replenish® Rewetting Drops (Control) when used by habitual contact lens wearers to bilaterally lubricate and rewet soft (hydrophilic) contact lenses including silicone hydrogel contact lenses and gas permeable (silicone acrylate and fluoro silicone acrylate) contact lenses.

Enrollment: 369 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects must be of legal age (at least 18) on the date the Informed Consent Form (ICF) is signed and have the capacity to provide voluntary informed consent
• Subjects must be habitual wearers of included contact lenses.
• Subjects must be adapted lens wearers and wear a lens in each eye and each lens must be of the same manufacture and brand.
• Subjects must agree to wear their lenses on a daily wear basis for approximately 1 month.

Exclusion criteria

• Subjects participating in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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369 participants in 2 patient groups

BL-300-PFM04

Experimental group

Treatment:

Device: BL-300-PFM04

Lubricating and rewetting drops

Active Comparator group

Treatment:

Device: OPTI-FREE