search
Back to results

BIOCLEAN FIRST CARE EX in Combination With Biofinity Lens

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Bioclean First Care EX / comfilcon A
Aosept Clearcare / comfilcon A
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Myopia

Eligibility Criteria

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

Inclusion Criteria:

  • Is over 18 years of age (inclusive)
  • Has had a self-reported visual exam in the last two years
  • Is currently an adapted spherical soft CL wearer
  • Has a CL spherical prescription between - 0.25 and - 12.00 (inclusive)
  • Has less than 1.00D spectacle cylinder in each eye.
  • Is correctable to a visual acuity of 20/20 or better in both eyes
  • Has clear corneas and no active ocular disease
  • Has read, understood and signed the information consent letter.
  • Is willing to comply with the wear schedule (at least 40 hrs per week)
  • Is willing to comply with the visit schedule

Exclusion Criteria:

  • Has never worn contact lenses before.
  • Currently wears rigid gas permeable contact lenses.
  • Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
  • Has a CL prescription outside the range of - 0.25 to -12.00D
  • Has a spectacle cylinder greater than -0.75D of cylinder in either eye.
  • Has best corrected spectacle distance vision worse than 20/20 in either eye.
  • Has any systemic disease affecting ocular health.
  • Is using any systemic or topical medications that will affect ocular health.
  • Has any ocular pathology or severe insufficiency of lacrimal secretion
  • Has persistent, clinically significant corneal or conjunctival staining
  • Has active neovascularization or any central corneal scars.
  • Is aphakic.
  • Is pregnant or lactating.
  • Has undergone corneal refractive surgery.
  • Is participating in any other type of eye related clinical or research study.

Sites / Locations

  • Kokama Eye Clinic
  • Higashihara Clinic
  • Dougenzaka Ioti Eye Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Bioclean First Care EX combo, then Aosept Clearcare combo

Aosept Clearcare combo, then Bioclean First Care EX combo

Arm Description

Subjects dispensed Bioclean First Care EX / comfilcon A combination then crossed over to the Aosept Clearcare / comfilcon A combination.

Subjects dispensed Aosept Clearcare / comfilcon A combination then crossed over to the Bioclean First Care EX / comfilcon A combination.

Outcomes

Primary Outcome Measures

Ocular Health - Corneal Staining
Corneal staining for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
Ocular Health - Conjunctival Redness
Conjunctival redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
Ocular Health - Limbal Redness
Limbal redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
Ocular Health - Papillary Conjunctivitis
Papillary conjunctivitis for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).

Secondary Outcome Measures

Stinging Sensation Right After Insertion (Subjective Rating)
Subjective rating of stinging sensation for the combinations is assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all).
Burning Sensation Right After Insertion (Subjective Rating)
Subjective rating of burning sensation right after insertion for each combination assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all).

Full Information

First Posted
July 18, 2014
Last Updated
July 19, 2020
Sponsor
Coopervision, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02196766
Brief Title
BIOCLEAN FIRST CARE EX in Combination With Biofinity Lens
Official Title
BIOCLEAN FIRST CARE EX in Combination With Biofinity Lens: A Two Week Crossover Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To determine if patients are unreactive to the lens care solution / Biofinity combination.
Detailed Description
To determine if patients are unreactive to the lens care solution / Biofinity combination in this cross-over study.

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
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bioclean First Care EX combo, then Aosept Clearcare combo
Arm Type
Active Comparator
Arm Description
Subjects dispensed Bioclean First Care EX / comfilcon A combination then crossed over to the Aosept Clearcare / comfilcon A combination.
Arm Title
Aosept Clearcare combo, then Bioclean First Care EX combo
Arm Type
Active Comparator
Arm Description
Subjects dispensed Aosept Clearcare / comfilcon A combination then crossed over to the Bioclean First Care EX / comfilcon A combination.
Intervention Type
Other
Intervention Name(s)
Bioclean First Care EX / comfilcon A
Intervention Description
Subjects dispensed Bioclean First Care EX / comfilcon A combination then crossed over to the alternate combination.
Intervention Type
Other
Intervention Name(s)
Aosept Clearcare / comfilcon A
Intervention Description
Subjects dispensed Aosept Clearcare / comfilcon A combination then crossed over to the alternate combination.
Primary Outcome Measure Information:
Title
Ocular Health - Corneal Staining
Description
Corneal staining for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
Time Frame
1 week
Title
Ocular Health - Conjunctival Redness
Description
Conjunctival redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
Time Frame
1 week
Title
Ocular Health - Limbal Redness
Description
Limbal redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
Time Frame
1 week
Title
Ocular Health - Papillary Conjunctivitis
Description
Papillary conjunctivitis for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Stinging Sensation Right After Insertion (Subjective Rating)
Description
Subjective rating of stinging sensation for the combinations is assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all).
Time Frame
Baseline
Title
Burning Sensation Right After Insertion (Subjective Rating)
Description
Subjective rating of burning sensation right after insertion for each combination assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all).
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Is over 18 years of age (inclusive) Has had a self-reported visual exam in the last two years Is currently an adapted spherical soft CL wearer Has a CL spherical prescription between - 0.25 and - 12.00 (inclusive) Has less than 1.00D spectacle cylinder in each eye. Is correctable to a visual acuity of 20/20 or better in both eyes Has clear corneas and no active ocular disease Has read, understood and signed the information consent letter. Is willing to comply with the wear schedule (at least 40 hrs per week) Is willing to comply with the visit schedule Exclusion Criteria: Has never worn contact lenses before. Currently wears rigid gas permeable contact lenses. Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day) Has a CL prescription outside the range of - 0.25 to -12.00D Has a spectacle cylinder greater than -0.75D of cylinder in either eye. Has best corrected spectacle distance vision worse than 20/20 in either eye. Has any systemic disease affecting ocular health. Is using any systemic or topical medications that will affect ocular health. Has any ocular pathology or severe insufficiency of lacrimal secretion Has persistent, clinically significant corneal or conjunctival staining Has active neovascularization or any central corneal scars. Is aphakic. Is pregnant or lactating. Has undergone corneal refractive surgery. Is participating in any other type of eye related clinical or research study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taku Muraoka, OD
Organizational Affiliation
Director Professional Services, CVI Japan
Official's Role
Study Director
Facility Information:
Facility Name
Kokama Eye Clinic
City
Joyo-shi
State/Province
Kyoto-fu
ZIP/Postal Code
610-0121
Country
Japan
Facility Name
Higashihara Clinic
City
Kameoka
State/Province
Kyoto-fu
ZIP/Postal Code
621-0861
Country
Japan
Facility Name
Dougenzaka Ioti Eye Clinic
City
Shibuya-ku
State/Province
Tokyo-to
ZIP/Postal Code
150-0043
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

BIOCLEAN FIRST CARE EX in Combination With Biofinity Lens

We'll reach out to this number within 24 hrs