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

NCT01583868 | Completed Results

• 1 other identifier: 755E
• Study Type: interventional
• Target: 216
• 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 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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• Visual Acuity

  Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).

  At 1 week follow up

Secondary Outcomes (1)

• Symptoms and Complaints

  At 1 Week follow up

Study Arms (4)

B&L RD2135-01 lens C

EXPERIMENTAL

Investigational Silicone hydrogel soft contact lens

Device: B&L RD2135-01 lens C

B&L RD2135-01 lens D

EXPERIMENTAL

Investigational Silicone hydrogel soft contact lens

Device: B&L RD2135-01 lens D

PureVision2

ACTIVE COMPARATOR

Bausch \& Lomb High definition soft contact lenses

Device: PureVision2

Ciba Vision Air Optix Aqua

ACTIVE COMPARATOR

Ciba Vision Air Optix Aqua soft contact lens

Device: Air Optix Aqua

Interventions

B&L RD2135-01 lens C DEVICE

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.

B&L RD2135-01 lens C

B&L RD2135-01 lens D DEVICE

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.

B&L RD2135-01 lens D

PureVision2 DEVICE

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.

PureVision2

Air Optix Aqua DEVICE

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.

Ciba Vision Air Optix Aqua

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.
• 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.

You may not qualify if:

• 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.

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: Study Director
• Organization: Bausch Health

robert.steffen@bausch.com

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: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2012
• First Posted: April 24, 2012
• Study Start: April 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2012
• Last Updated: October 22, 2020
• Results First Posted: October 22, 2020

Record last verified: 2020-09

Locations

US (1)