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

Bausch & Lomb Incorporated369 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

369

Conditions

Contact Lens Wear

Interventions

BL-300-PFM04DEVICE

Preservative Free Lubricating and Rewetting Drops for use during contact lens wear

OPTI-FREEDEVICE

Replenish Rewetting Drops

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (15)

Bausch Site 108

San Francisco, California, United States

Bausch Site 111

Torrance, California, United States

Bausch Site 106

Sarasota, Florida, United States

Outcomes

Primary Outcomes

Overall Comfort Averaged Over All Follow-up Visits

Overall comfort will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response. For each eye, mean overall comfort over all follow-up visits will be computed as the average of the non-missing values overall scheduled follow-up visits.

Time frame: 1 month

Dryness Averaged Over All Follow-up Visits

Dryness will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response. For each eye, mean dryness over all follow-up visits will be computed as the average of the non-missing values over all scheduled follow-up visits.

Time frame: 1 month

Proportion of Eyes With Slit Lamp Findings Greater Than Grade 2 at Any Follow-up Visit

At each follow-up visit, graded slit lamp findings will be assessed for each eye using Grades 0 through 4. Using only the non-missing observations from all visits without imputation, each eye will be classified with respect to findings greater than grade 2 at any visit (Absent, Present).

Time frame: 1 month

Data from ClinicalTrials.gov

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