A Study to Evaluate the 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: NCT01412983
• Other study ID #: 713E
• Status: Completed
• Phase: N/A
• First received: August 8, 2011
• Last updated: March 27, 2014
• Start date: August 2011
• Est. completion date: October 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 lenses developed by Bausch + Lomb.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings (greater than grade 1 and/or presence of infiltrates).

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

• Be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.

• Be myopic and require lens correction from -0.50 to -6.00 diopters (D) in each eye.

Exclusion Criteria:

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

• Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months.

• Any Grade 2 or greater finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.

• Any scar or neovascularization within the central 4mm of the cornea.

• Have had any corneal surgery.

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

• Any systemic disease affecting ocular health.

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

• Currently wear monovision, multifocal, or toric contact lenses.

• 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), Primary Purpose: Screening

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Bausch & Lomb Test lens
Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses.
• Ciba Vision soft contact lens
Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses.

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	The mean difference in high contrast logMAR, over all lens visual acuities (VAs) between lens groups.	One week	No
Secondary	Overall Comfort	The mean difference in comfort-related symptoms/complaints scores between lens groups. Rated on a scale of 0-100 with 100 being the most favorable score.	One week	No