A Study to Evaluate the Product Feasibility of Two New Silicone Hydrogel Contact Lenses

The objective of this study is to determine the clinical feasibility and to evaluate the product performance of two RD2135-01 investigational soft contact lenses (Test 1 and Test 2) developed by Bausch + Lomb. The Test lenses will be compared to both Bausch + Lomb PureVision®2 HD (high definition) soft contact lenses and Ciba Vision Air Optix Aqua soft contact lenses when used among currently adapted soft contact lens wearers.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: B&L RD2135-01 lens C; Device: B&L RD2135-01 lens D; Device: PureVision2; Device: Air Optix Aqua

• Study Type: Interventional
• Enrollment (Actual): 216
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14609
      • Bausch & Lomb Incorporated

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
• 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 diopters (D) to -6.00 D in each eye.
• Must agree to wear the study lenses on a daily wear basis for the duration of the study.
• Must be willing to use a lens care system on a regular basis.
• If the subject requires a Washout Period, the subject must be willing to discontinue contact lens wear and be willing to wear either spectacles or no lenses during this Washout Period.

Exclusion Criteria:

• Not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses.
• Have 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 scar or neovascularization within the central 4mm of the cornea.
• Any Grade 2 or greater finding during the slit lamp examination, Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
• Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
• Anisometropia (spherical equivalent) of greater than 2.00 D.
• Any systemic disease affecting ocular health.
• Using any systemic or topical medications that will affect ocular physiology or lens performance.
• Aphakic.
• Amblyopic.
• Allergic to any component in the study products.
• Have had any corneal surgery (ie, refractive surgery).
• Currently wear monovision correction, multifocal, or toric contact lenses.
• Ocular astigmatism greater than 1.00 D in either eye.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: B&L RD2135-01 lens C; Investigational Silicone hydrogel soft contact lens	Device: B&L RD2135-01 lens C; Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.
Experimental: B&L RD2135-01 lens D; Investigational Silicone hydrogel soft contact lens	Device: B&L RD2135-01 lens D; Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.
Active Comparator: PureVision2; Bausch & Lomb High definition soft contact lenses	Device: PureVision2; Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.
Active Comparator: Ciba Vision Air Optix Aqua; Ciba Vision Air Optix Aqua soft contact lens	Device: Air Optix Aqua; Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity	Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).	At 1 week follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms and Complaints	Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints. Symptoms/complaints were recorded for each eye based on the participant's experience with their study lenses worn for that respective treatment period. Symptoms/complaints parameters included the following: Burning/stinging upon insertion, Comfort upon insertion, Overall comfort, Comfort at end of day, Ease of handling/insertion, Ease of handling/removal, Dryness, Itchiness, Redness, Vision upon insertion, Vision, Vision in low light, Lens cleanness upon insertion, Lens cleanness upon removal, Lens cleanness, Dryness at end of day, and Overall impression.	At 1 Week follow up

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: April 23, 2012
• First Submitted That Met QC Criteria: April 23, 2012
• First Posted (Estimate): April 24, 2012

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: September 29, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 755E