A Study to Evaluate 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: NCT01309893
• Other study ID #: 687E
• Status: Completed
• Phase: N/A
• First received: March 4, 2011
• Last updated: November 20, 2014
• Start date: December 2010
• Est. completion date: February 2011

Study information

• Verified date: November 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 lenses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: February 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.

• Be myopic and require lens correction from -0.50 D to -5.50 D in each eye.

Exclusion Criteria:

• Any systemic disease affecting ocular health.

• Using any systemic or topical medications that will affect ocular physiology or lens performance.

• An active ocular disease, any corneal infiltrative response or are using any ocular medications.

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

• Allergic to any component in the study care products.

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
Lenses worn on a daily wear basis for one week
• Air Optix Aqua lens
Lenses worn on a daily wear basis for one week

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	Distance High Contrast logMAR Visual Acuity at 1 Week	Mean difference in distance high contrast logMAR over all lens VAs (visual acuity) from Baseline and 1 Week	Baseline & 1 week	No
Secondary	Slit Lamp Findings = Grade 2	Slit lamp findings are measured on a scale of 0-4, where 0=none, and 4=severe. The slit lamp exam is a routine procedure done to evaluate eye health and determine eligibility for clinical trial. It provides view of the different parts of the eye. During the exam, a doctor can look at the front parts of the eye, including the cornea, the lens, the iris and other parts of the anterior segment of the eye. Fluorescein dye may be used during a slit lamp examination to make it easier to detect inflammation, infections, or injured area on the cornea.	1 week	No
Secondary	Overall Comfort	Comfort measured by participant on a scale of 0-100 with 100 being the most favorable.	1 week	No