Clinical trial NCT03351101: Clinical Study of Approved Contact Lenses
Official title: Clinical Study of Approved Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2017-11-22
Enrollment: 271
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, bilateral, d o u b l e - masked, 1-month study with two parallel groups
Primary purpose: TREATMENT

Brief summary: Evaluation of Johnson \& Johnson Acuvue Vita (senofilcon C) soft contact lenses to the Bausch + Lomb Ultra (samfilcon A) soft contact lenses

Detailed description: to compare the performance of currently marketed Johnson \& Johnson Acuvue Vita (senofilcon C) soft contact lenses to the currently marketed Bausch + Lomb Ultra (samfilcon A) soft contact lenses among adapted wearers of Acuvue Oasys soft contact lenses.

Eligibility criteria: Inclusion Criteria:

1. Subjects must be between the ages of 18 and 40 years old, inclusive, on the date the Informed Consent Form (ICF) is signed and have the capacity to provide voluntary informed consent.
2. Subjects must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide authorization as appropriate for local privacy regulations.
3. Subjects must be willing and able to comply with all treatment and follow-up/study procedures.
4. Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
5. Subjects must have clear central corneas and be free of any anterior segment disorders.
6. Subjects must be myopic and require contact lens sphere power correction from -0.50 diopter (D) to -6.00 D (considering vertex distance adjustments in both eyes).
7. Subjects must be habitual wearers of Johnson \& Johnson Acuvue Oasys single vision spherical soft contact lenses in each eye.
8. Subjects must use a contact lens care regimen on a routine basis.
9. Subjects must agree to wear their study lenses on a daily wear basis for the duration

Exclusion Criteria:

1. 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
2. Subjects who are women of childbearing potential (those who are not surgically sterilized or postmenopausal) are excluded from participation in the investigation if they meet any one of the following conditions:

   * she is currently pregnant
   * she plans to become pregnant during the study
   * she is breastfeeding
3. Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
4. Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.

Primary outcomes:
measure: End of Day Comfort
timeFrame: 1 month
measure: Overall Vision
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: valeant Site 02
state: California
city: San Francisco
country: United States
facility: Valeant Site 03
state: California
city: Denver
country: United States
facility: Valeant Site 04
state: Colorado
city: Orlando
country: United States
facility: Valeant Site 06
state: Florida
city: Orlando
country: United States
facility: Valeant Site 01
state: Florida
city: Sarasota
country: United States
facility: Valeant Site 05
state: Florida
city: Pittsburg
country: United States
facility: Valeant Site 07
state: Kansas
city: Warrensburg
country: United States
facility: Valeant Site 08
state: Missouri
city: Vestal
country: United States
facility: Valeant Site 09
state: New York
city: Powell
country: United States
facility: Valeant Site 10
state: Ohio
city: New Berlin
country: United States
facility: Valeant Site 11
state: Wisconsin
Study officials:
References: