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

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
B&L RD2135-01 lens C
B&L RD2135-01 lens D
PureVision2
Air Optix Aqua
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bausch & Lomb Incorporated

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

B&L RD2135-01 lens C

B&L RD2135-01 lens D

PureVision2

Ciba Vision Air Optix Aqua

Arm Description

Investigational Silicone hydrogel soft contact lens

Investigational Silicone hydrogel soft contact lens

Bausch & Lomb High definition soft contact lenses

Ciba Vision Air Optix Aqua soft contact lens

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
April 23, 2012
Last Updated
September 29, 2020
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01583868
Brief Title
A Study to Evaluate the Product Feasibility of Two New Silicone Hydrogel Contact Lenses
Official Title
A Study to Evaluate the Product Feasibility of Two New Silicone Hydrogel Contact Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
B&L RD2135-01 lens C
Arm Type
Experimental
Arm Description
Investigational Silicone hydrogel soft contact lens
Arm Title
B&L RD2135-01 lens D
Arm Type
Experimental
Arm Description
Investigational Silicone hydrogel soft contact lens
Arm Title
PureVision2
Arm Type
Active Comparator
Arm Description
Bausch & Lomb High definition soft contact lenses
Arm Title
Ciba Vision Air Optix Aqua
Arm Type
Active Comparator
Arm Description
Ciba Vision Air Optix Aqua soft contact lens
Intervention Type
Device
Intervention Name(s)
B&L RD2135-01 lens C
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
B&L RD2135-01 lens D
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
PureVision2
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Air Optix Aqua
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Acuity
Description
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
Time Frame
At 1 week follow up
Secondary Outcome Measure Information:
Title
Symptoms and Complaints
Description
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.
Time Frame
At 1 Week follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beverly J Barna, CCRA
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Bausch & Lomb Incorporated
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States

12. IPD Sharing Statement

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

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