Performance of Aspheric Hydrogel Lenses After a Refit With Sphere Silicone Hydrogel Lenses for 4 Weeks

Ametropia Clinical Trial

Official title:

Performance of Aspheric Hydrogel Lenses After a Refit With Sphere Silicone Hydrogel Lenses for 4 Weeks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03835078
• Other study ID #: EX-MKTG-98
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: July 6, 2019

Study information

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

Clinical Trial Summary

The aim of this prospective study is to evaluate the clinical performance of habitual wearers of methafilcon A aspheric lenses after a refit with fanfilcon A sphere lenses for 4 weeks of daily wear.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 6, 2019
• Est. primary completion date: March 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Is between 18 and 40 years of age (inclusive)

• Has had a self-reported visual exam in the last two years

• Is an adapted soft contact lens wearer

• Has a contact lens spherical prescription between - 0.25 to - 8.00 (inclusive)

• Have no less than -0.75D (Diopter) of astigmatism in both eyes

• Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.

• Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.

• Has clear corneas and no active ocular disease

• Has read, understood and signed the information consent letter

• Patient contact lens refraction should fit within the available parameters of the study lenses

• Is willing to comply with the wear schedule (at least 5 days per week, >8 hours/day assuming there are no contraindications for doing so)

• Is willing to comply with the visit schedule

Exclusion Criteria:

• Has a Contact Lens (CL) prescription outside the range of the available parameters of the study lenses

• Has a spectacle cylinder of = 1.00D (Diopter) in either eye

• Has a history of not achieving comfortable Contact Lens (CL) wear (5 days per week; > 8 hours/day)

• Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye

• Presence of clinically significant (grade 2-4) anterior segment abnormalities

• Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear

• Slit lamp findings that would contraindicate contact lens wear such as:

• Pathological dry eye or associated findings

• Pterygium, pinguecula, or corneal scars within the visual axis

• Neovascularization > 0.75 mm in from of the limbus

• Giant papillary conjunctivitis (GCP) worse than grade 1

• Anterior uveitis or iritis (past or present)

• Seborrheic eczema, Seborrheic conjunctivitis

• History of corneal ulcers or fungal infections

• Poor personal hygiene

Related Conditions & MeSH terms

• Ametropia
• Refractive Errors

Intervention

Device:
• methafilcon A contact lenses
Bilateral daily wear of methafilcon A contact lenses
• fanfilcon A contact lenses
Bilateral daily wear of fanfilcon A contact lenses

Locations

Country	Name	City	State
Mexico	Optometry Clinic, National Autonomous University	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses	Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).	Baseline
Primary	Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses	Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).	4 weeks
Primary	Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses	Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).	Baseline
Primary	Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses	Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).	2 weeks
Primary	Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses	Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).	4 weeks
Primary	Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Contact Lenses	Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea	Baseline
Primary	Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Contact Lenses	Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea	4 weeks
Primary	Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses	Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea	Baseline
Primary	Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses	Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea	2 weeks
Primary	Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses	Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea	4 weeks
Primary	Post-blink Movement Assessment by the Investigator - Methafilcon A Contact Lenses	Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).	Baseline
Primary	Post-blink Movement Assessment by the Investigator - Methafilcon A Contact Lenses	Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).	4 weeks
Primary	Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses	Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).	Baseline
Primary	Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses	Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).	2 weeks
Primary	Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses	Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).	4 weeks
Primary	Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses	Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).	Baseline
Primary	Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses	Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).	4 weeks
Primary	Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses	Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).	Baseline
Primary	Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses	Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).	2 weeks
Primary	Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses	Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).	4 weeks
Primary	Overall Lens Fit Acceptance by the Investigator - Methafilcon A Contact Lenses	Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect	Baseline
Primary	Overall Lens Fit Acceptance by the Investigator - Methafilcon A Contact Lenses	Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect	4 weeks
Primary	Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses	Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect	Baseline
Primary	Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses	Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect	2 weeks
Primary	Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses	Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect	4 weeks
Secondary	Average Daily Wearing Time - Methafilcon A Contact Lenses	Average daily wearing time response by the subject	4 weeks
Secondary	Average Daily Wearing Time - Fanfilcon A Contact Lenses	Average daily wearing time response by the subject.	2 weeks
Secondary	Average Daily Wearing Time - Fanfilcon A Contact Lenses	Average daily wearing time response by the subject	4 weeks
Secondary	Average Comfortable Wearing Time - Methafilcon A Contact Lenses	Average comfortable wearing time - response by the subject	4 weeks
Secondary	Average Comfortable Wearing Time - Fanfilcon A Contact Lenses	Average comfortable wearing time - response by the subject	2 weeks
Secondary	Average Comfortable Wearing Time - Fanfilcon A Contact Lenses	Average comfortable wearing time - response by the subject	4 weeks