Performance of Toric Hydrogel Lenses Following A Refit With Toric Silicone Hydrogel Lenses for 1 Month

Ametropia Clinical Trial

Official title:

Performance of Toric Hydrogel Lenses Following A Refit With Toric Silicone Hydrogel Lenses for 1 Month

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03835221
• Other study ID #: EX-MKTG-96
• 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 toric lenses after a refit with fanfilcon A toric lenses for 1-month of daily wear.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• 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 +6.00 to - 8.00 (inclusive)-Have no less than -0.75D of astigmatism and no more than -2.25 D 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 less than -0.75D or more than -2.50 D of cylinder 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

• Has a known history of corneal hypoesthesia (reduced corneal sensitivity)

• Has aphakia, keratoconus or a highly irregular cornea

• Has Presbyopia or has dependence on spectacles for near work over the contact lenses

• Has undergone corneal refractive surgery

• Is participating in any other type of eye related clinical or research study.

Related Conditions & MeSH terms

• Ametropia
• Refractive Errors

Intervention

Device:
• methafilcon A toric contact lenses
Bilateral daily wear of methafilcon A toric contact lenses
• fanfilcon A toric contact lenses
Bilateral daily wear of fanfilcon A toric 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	Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses	Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).	Baseline
Primary	Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses	Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).	4 weeks
Primary	Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).	Baseline
Primary	Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).	2 weeks
Primary	Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Lens centration was assessed on a 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 Toric Contact Lenses	Corneal coverage was 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 Toric Contact Lenses	Corneal coverage was 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 Toric Contact Lenses	Corneal coverage was 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 Toric Contact Lenses	Corneal coverage was 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 Toric Contact Lenses	Corneal coverage was 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 Toric Contact Lenses	Post-blink movement was assessed on a 0-4 scale (where: 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 Toric Contact Lenses	Post-blink movement was assessed on a 0-4 scale (where: 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 Toric Contact Lenses	Post-blink movement was assessed on a 0-4 scale (where: 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 Toric Contact Lenses	Post-blink movement was assessed on a 0-4 scale (where: 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 Toric Contact Lenses	Post-blink movement was assessed on a 0-4 scale (where: 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 Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses	Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.	Baseline
Primary	Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses	Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.	4 weeks
Primary	Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.	Baseline
Primary	Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.	2 weeks
Primary	Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.	4 weeks
Primary	Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses	Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position	Baseline
Primary	Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses	Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position	4 weeks
Primary	Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position	Baseline
Primary	Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position	2 weeks
Primary	Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position	4 weeks
Primary	Overall Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses	Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).	Baseline
Primary	Overall Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses	Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).	4 weeks
Primary	Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).	Baseline
Primary	Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).	2 weeks
Primary	Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).	4 weeks
Primary	Overall Lens Fit Acceptance by the Investigator - Methafilcon A Toric Contact Lenses	Overall lens fit acceptance assessed using grade (0-4) 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 Toric Contact Lenses	Overall lens fit acceptance assessed using grade (0-4) 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 Toric Contact Lenses	Overall lens fit acceptance assessed using grade (0-4) 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 Toric Contact Lenses	Overall lens fit acceptance assessed using grade (0-4) 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 Toric Contact Lenses	Overall lens fit acceptance assessed using grade (0-4) 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 Toric Contact Lenses	Average daily wearing time response by the subject	4 weeks
Secondary	Average Daily Wearing Time - Fanfilcon A Toric Contact Lenses	Average daily wearing time response by the subject	2 weeks
Secondary	Average Daily Wearing Time - Fanfilcon A Toric Contact Lenses	Average daily wearing time response by the subject	4 weeks
Secondary	Average Comfortable Wearing Time - Methafilcon A Toric Contact Lenses	Average comfortable wearing time - response by the subject	4 weeks
Secondary	Average Comfortable Wearing Time - Fanfilcon A Toric Contact Lenses	Average comfortable wearing time - response by the subject	2 weeks
Secondary	Average Comfortable Wearing Time - Fanfilcon A Toric Contact Lenses	Average comfortable wearing time - response by the subject	4 weeks