Clinical Study of Approved Contact Lenses

Myopia Clinical Trial

Official title:

Clinical Study of Approved Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03351101
• Other study ID #: ROC2-17-014
• Status: Completed
• Phase: N/A
• Start date: October 23, 2017
• Est. completion date: December 8, 2017

Study information

• Verified date: January 2021
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: December 8, 2017
• Est. primary completion date: November 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Senofilcon C
Senofilcon C Contact Lens
• Samfilcon A
Samfilcon A Contact Lens

Locations

Country	Name	City	State
United States	Valeant Site 04	Denver	Colorado
United States	Valeant Site 11	New Berlin	Wisconsin
United States	Valeant Site 01	Orlando	Florida
United States	Valeant Site 06	Orlando	Florida
United States	Valeant Site 07	Pittsburg	Kansas
United States	Valeant Site 10	Powell	Ohio
United States	valeant Site 02	San Diego	California
United States	Valeant Site 03	San Francisco	California
United States	Valeant Site 05	Sarasota	Florida
United States	Valeant Site 09	Vestal	New York
United States	Valeant Site 08	Warrensburg	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	End of Day Comfort	The 100 point , take home questionnaire evaluated performance of the lenses based on subject responses. Possible scores were 0-100. Higher scores indicated greater comfort.	1 month
Primary	Overall Vision	The 100 point , take home questionnaire evaluated performance of the lenses based on subject responses. Possible scores were 0-100. Higher scores indicated better overall vision.	1 month