Feasibility of a New Silicone Hydrogel Lens

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01131130
• Other study ID #: 655
• Status: Completed
• Phase: N/A
• First received: May 25, 2010
• Last updated: March 28, 2014
• Start date: May 2010
• Est. completion date: June 2010

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 product feasibility of the investigational contact lens (Test) when compared to the currently marketed Acuvue Oasys contact lens (Control) and the Air Optix Aqua contact lens (Control) when worn by adapted wearers of soft contact lenses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

• Participants 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.

• Participants must be myopic and require lens correction from -0.75 D to - 4.75D in each eye.

Exclusion Criteria:

• Participants who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.

• Participants with any systemic disease affecting ocular health.

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

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

• Participants who have had any corneal surgery (eg, refractive surgery).

• Participants who are allergic to any component in the study care products.

Study Design

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

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Investigational contact lens
After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type.
• Acuvue Oasys Contact Lens
After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type.
• Air Optix Aqua
After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type.

Locations

Country	Name	City	State
United States	Bausch & Lomb	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	Comfort Throughout the Day - Test Lens vs. Air Optix Aqua Lens	Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable.	7 days	No
Primary	Comfort Throughout the Day - Test Lens vs. Acuvue Oasys	Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable.	7 days	No
Secondary	Lens Wettability, Test Lens vs. Acuvue Oasys	Lens wettability was assessed at each visit as Grade 4 - 0, with 4=optimal (100% of anterior surface wettable) and 0=severe (Presence of one or more non-wetting areas > 0.5 mm in size).	7 days	No
Secondary	Lens Wettability, Test Lens vs. Air Optix Aqua	Lens wettability was assessed at each visit as Grade 4 - 0, with 4=optimal (100% of anterior surface wettable) and 0=severe (Presence of one or more non-wetting areas > 0.5 mm in size).	7 days	No