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BIOCLEAN FIRST CARE EX in Combination With Biofinity Lens

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ClinicalTrials.gov Identifier: NCT02196766
Recruitment Status : Completed
First Posted : July 22, 2014
Results First Posted : April 29, 2016
Last Update Posted : April 29, 2016
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.

Brief Summary:
To determine if patients are unreactive to the lens care solution / Biofinity combination.

Condition or disease Intervention/treatment Phase
Myopia Other: Bioclean First Care EX / comfilcon A Other: Aosept Clearcare / comfilcon A Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Official Title: BIOCLEAN FIRST CARE EX in Combination With Biofinity Lens: A Two Week Crossover Study
Study Start Date : July 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Bioclean First Care EX combo, then Aosept Clearcare combo
Subjects dispensed Bioclean First Care EX / comfilcon A combination then crossed over to the Aosept Clearcare / comfilcon A combination.
Other: Bioclean First Care EX / comfilcon A
Subjects dispensed Bioclean First Care EX / comfilcon A combination then crossed over to the alternate combination.

Other: Aosept Clearcare / comfilcon A
Subjects dispensed Aosept Clearcare / comfilcon A combination then crossed over to the alternate combination.

Active Comparator: Aosept Clearcare combo, then Bioclean First Care EX combo
Subjects dispensed Aosept Clearcare / comfilcon A combination then crossed over to the Bioclean First Care EX / comfilcon A combination.
Other: Bioclean First Care EX / comfilcon A
Subjects dispensed Bioclean First Care EX / comfilcon A combination then crossed over to the alternate combination.

Other: Aosept Clearcare / comfilcon A
Subjects dispensed Aosept Clearcare / comfilcon A combination then crossed over to the alternate combination.




Primary Outcome Measures :
  1. Ocular Health - Corneal Staining [ Time Frame: 1 week ]
    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).

  2. Ocular Health - Conjunctival Redness [ Time Frame: 1 week ]
    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).

  3. Ocular Health - Limbal Redness [ Time Frame: 1 week ]
    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).

  4. Ocular Health - Papillary Conjunctivitis [ Time Frame: 1 week ]
    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 :
  1. Stinging Sensation Right After Insertion (Subjective Rating) [ Time Frame: Baseline ]
    Subjective rating of stinging sensation for the combinations is assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all).

  2. Burning Sensation Right After Insertion (Subjective Rating) [ Time Frame: Baseline ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02196766


Locations
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Japan
Kokama Eye Clinic
Joyo-shi, Kyoto-fu, Japan, 610-0121
Higashihara Clinic
Kameoka, Kyoto-fu, Japan, 621-0861
Dougenzaka Ioti Eye Clinic
Shibuya-ku, Tokyo-to, Japan, 150-0043
Sponsors and Collaborators
Coopervision, Inc.
Investigators
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Study Director: Taku Muraoka, OD Director Professional Services, CVI Japan

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Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT02196766     History of Changes
Other Study ID Numbers: CVJ-EX-MKTG-1818
First Posted: July 22, 2014    Key Record Dates
Results First Posted: April 29, 2016
Last Update Posted: April 29, 2016
Last Verified: March 2016