Product Feasibility of a New Silicone Hydrogel Contact Lens

Myopia Clinical Trial

Official title:

A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01309100
• Other study ID #: 672E
• Status: Completed
• Phase: N/A
• First received: March 3, 2011
• Last updated: March 27, 2014
• Start date: November 2010
• Est. completion date: January 2011

Study information

• Verified date: March 2014
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lens.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects must have clear central corneas and be free of any anterior segment disorders.

• Subjects must be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.

• Subjects must be myopic and require lens correction

Exclusion Criteria:

• Subjects with any systemic disease affecting ocular health.

• Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.

• Subjects with an active ocular disease or are using any ocular medication.

• Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Investigational Lens
Bausch & Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week.
• Acuvue Oasys Lens
Johnson & Johnson Acuvue Oasys contact lens on a daily wear basis for 1 week.
• Air Optix Aqua Lens
Ciba Vision Air Optix Aqua contact lens on a daily wear basis for 1 week.

Locations

Country	Name	City	State
United States	Bausch & Lomb Incorporated	Rochester	New York

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	Visual Acuity (Investigational vs Air Optix Aqua Lens)	The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens (RD2117-01) and the Air Optix Aqua control lens.	1 week	No
Primary	Visual Acuity (Investigational vs Acuvue Oasys Lens)	The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens(RD2117-01) and the Acuvue Oasys control lens.	1 week	No
Secondary	Comfort Throughout the Day (Investigational vs Acuvue Oasys Lens)	The mean differences in comfort between the investigational lens (RD2117-01) and the Acuvue Oasys control lens. Comfort was measured on a scale of 0 to 100, with 100 being the most favorable score.	1 week	No
Secondary	Comfort Throughout the Day (Investigational vs Air Optix Aqua Lens)	The mean differences in comfort between the investigational lens(RD2117-01) and the Air Optix Aqua control lens. Comfort was measured on a scale of 0 to 100, with 100 being the most favorable score.	1 week	No