BIOCLEAN FIRST CARE EX in Combination With Biofinity Lens

NCT02196766 | Completed Results

• 1 other identifier: CVJ-EX-MKTG-1818
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Myopia

Outcome Measures

Primary Outcomes (4)

• 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).

  1 week

• 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).

  1 week

• 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).

  1 week

• 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).

  1 week

Secondary Outcomes (2)

• Stinging Sensation Right After Insertion (Subjective Rating)

  Baseline

• Burning Sensation Right After Insertion (Subjective Rating)

  Baseline

Study Arms (2)

Bioclean First Care EX combo, then Aosept Clearcare combo

ACTIVE COMPARATOR

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; Other: Aosept Clearcare / comfilcon A

Aosept Clearcare combo, then Bioclean First Care EX combo

ACTIVE COMPARATOR

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; Other: Aosept Clearcare / comfilcon A

Interventions

Bioclean First Care EX / comfilcon A OTHER

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

Aosept Clearcare combo, then Bioclean First Care EX combo; Bioclean First Care EX combo, then Aosept Clearcare combo

Aosept Clearcare / comfilcon A OTHER

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

Aosept Clearcare combo, then Bioclean First Care EX combo; Bioclean First Care EX combo, then Aosept Clearcare combo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (3)

Kokama Eye Clinic

Joyo-shi, Kyoto, 610-0121, Japan

Location

Higashihara Clinic

Kameoka, Kyoto, 621-0861, Japan

Location

Dougenzaka Ioti Eye Clinic

Shibuya-ku, Tokyo-to, 150-0043, Japan

Location

MeSH Terms

Conditions

Myopia

Interventions

comfilcon A

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Taku Muraoka, OD, Director Professional Services Organization
• Organization: Coopervision Japan

taku.muraoka@jp.coopervision.com

81-3-5449-6619

Study Officials

• Taku Muraoka, OD

  Director Professional Services, CVI Japan

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

Study Record Dates

• First Submitted: July 18, 2014
• First Posted: July 22, 2014
• Study Start: July 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: July 29, 2020
• Results First Posted: April 29, 2016

Record last verified: 2020-07

Locations

JP (3)