BIOCLEAN FIRST CARE EX in Combination With Biofinity Lens

Myopia Clinical Trial

Official title:

BIOCLEAN FIRST CARE EX in Combination With Biofinity Lens: A Two Week Crossover Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02196766
• Other study ID #: CVJ-EX-MKTG-1818
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: August 2014

Study information

• Verified date: July 2020
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

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

Locations

Country	Name	City	State
Japan	Kokama Eye Clinic	Joyo-shi	Kyoto-fu
Japan	Higashihara Clinic	Kameoka	Kyoto-fu
Japan	Dougenzaka Ioti Eye Clinic	Shibuya-ku	Tokyo-to

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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).	Baseline
Secondary	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).	Baseline