BIOCLEAN FIRST CARE EX in Combination With Biofinity Lens

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Other: Bioclean First Care EX / comfilcon A; Other: Aosept Clearcare / comfilcon A

• Registration Number: NCT02196766
• Lead Sponsor: Coopervision, Inc.

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-18
• Study First Submitted QC: 2014-07-18
• Study First Posted: 2014-07-22
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Results First Submitted: 2015-12-15
• Results First Submitted QC: 2016-03-30
• Results First Posted: 2016-04-29
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-19
• Last Update Posted: 2020-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Aosept Clearcare combo, then Bioclean First Care EX combo	Bioclean First Care EX / comfilcon A	Subjects dispensed Aosept Clearcare / comfilcon A combination then crossed over to the Bioclean First Care EX / comfilcon A combination.
Bioclean First Care EX combo, then Aosept Clearcare combo	Aosept Clearcare / comfilcon A	Subjects dispensed Bioclean First Care EX / comfilcon A combination then crossed over to the Aosept Clearcare / comfilcon A combination.
Bioclean First Care EX combo, then Aosept Clearcare combo	Bioclean First Care EX / comfilcon A	Subjects dispensed Bioclean First Care EX / comfilcon A combination then crossed over to the Aosept Clearcare / comfilcon A combination.
Aosept Clearcare combo, then Bioclean First Care EX combo	Aosept Clearcare / comfilcon A	Subjects dispensed Aosept Clearcare / comfilcon A combination then crossed over to the Bioclean First Care EX / comfilcon A combination.

Primary Outcome Measures

Name	Time	Method
Ocular Health - Limbal Redness	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).
Ocular Health - Corneal Staining	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).
Ocular Health - Papillary Conjunctivitis	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).
Ocular Health - Conjunctival Redness	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).

Secondary Outcome Measures

Name	Time	Method
Stinging Sensation Right After Insertion (Subjective Rating)	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).
Burning Sensation Right After Insertion (Subjective Rating)	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).

Trial Locations

Locations (3)

Higashihara Clinic; 🇯🇵 Kameoka, Kyoto-fu, Japan

Dougenzaka Ioti Eye Clinic; 🇯🇵 Shibuya-ku, Tokyo-to, Japan

Kokama Eye Clinic; 🇯🇵 Joyo-shi, Kyoto-fu, Japan