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

NCT01412983 | Completed Results

• 1 other identifier: 713E
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• Visual Acuity

  The mean difference in high contrast logMAR, over all lens visual acuities (VAs) between lens groups.

  One week

Secondary Outcomes (1)

• Overall Comfort

  One week

Study Arms (2)

Bausch & Lomb Test Lens

EXPERIMENTAL

Bausch + Lomb investigational soft contact lens

Device: Bausch & Lomb Test lens

Ciba Vision soft contact lens

ACTIVE COMPARATOR

Ciba Vision Air Optix Aqua soft contact lens

Device: Ciba Vision soft contact lens

Interventions

Bausch & Lomb Test lens DEVICE

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.

Bausch & Lomb Test Lens

Ciba Vision soft contact lens DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Bausch & Lomb Incorporated

Rochester, New York, 14609, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Dr. Robert Steffen
• Organization: Bausch & Lomb

robbert.steffen@bausch.com

1 585 338 6399

Study Officials

• Beverly J Barna, CCRA

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2011
• First Posted: August 9, 2011
• Study Start: August 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: October 1, 2011
• Last Updated: April 29, 2014
• Results First Posted: April 29, 2014

Record last verified: 2014-03

Locations

US (1)