Clinical trial NCT04175340: A Safety and Effectiveness Study of a New Preservative Free Rewetting Drop
Official title: A Safety and Effectiveness Study of a New Preservative Free Rewetting Drop
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens Wear
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2019-11-25
Enrollment: 369
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall Comfort Averaged Over All Follow-up Visits
timeFrame: 1 month
measure: Dryness Averaged Over All Follow-up Visits
timeFrame: 1 month
measure: Proportion of Eyes With Slit Lamp Findings Greater Than Grade 2 at Any Follow-up Visit
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Bausch Site 108
state: California
city: Torrance
country: United States
facility: Bausch Site 111
state: California
city: Sarasota
country: United States
facility: Bausch Site 106
state: Florida
city: Decatur
country: United States
facility: Bausch Site 104
state: Georgia
city: Bloomington
country: United States
facility: Bausch Site 110
state: Kansas
city: Leavenworth
country: United States
facility: Bausch Site 112
state: Kansas
city: Portland
country: United States
facility: Bausch Site 107
state: Maine
city: Edina
country: United States
facility: Bausch Site 109
state: Minnesota
city: Jamestown
country: United States
facility: Bausch Site 102
state: New York
city: Vestal
country: United States
facility: Bausch Site 113
state: New York
city: Miamisburg
country: United States
facility: Bausch Site 101
state: Ohio
city: West Chester
country: United States
facility: Bausch Site 105
state: Ohio
city: Grants Pass
country: United States
facility: Bausch Site 114
state: Oregon
city: Brentwood
country: United States
facility: Bausch Site 115
state: Tennessee
city: Nashville
country: United States
facility: Bausch Site 103
state: Tennessee
Study officials:
References: