Performance of Toric Silicone Hydrogel Contact Lenses Following One Month of Daily Wear

Astigmatism Clinical Trial

Official title:

Performance of Toric Silicone Hydrogel Contact Lenses Following One Month of Daily Wear

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03418064
• Other study ID #: EX-MKTG-90
• Status: Completed
• Phase: N/A
• Start date: February 10, 2018
• Est. completion date: May 16, 2018

Study information

• Verified date: October 2019
• 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 fanfilcon A toric and lotrafilcon B toric contact lenses after 1 month of wear in each pair.

Description:

The aim of this prospective study is to evaluate the clinical performance of Avaira Vitality toric (fanfilcon A) and AIR OPTIX for Astigmatism (lotrafilcon B) contact lenses after 1 month of wear in each pair.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 16, 2018
• Est. primary completion date: May 16, 2018
• 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 - 9.00 (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:

A person will be excluded from the study if he/she:

• Has a 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 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

• Astigmatism

Intervention

Device:
• Fanfilcon A toric lens
Contact lens
• Lotrafilcon B toric lens
Contact lens

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	Lens Centration	Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable)	Baseline
Primary	Lens Centration	Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable)	Dispense
Primary	Lens Centration	Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable)	1 Month
Primary	Corneal Coverage	Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete)	Baseline
Primary	Corneal Coverage	Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete)	Dispense
Primary	Corneal Coverage	Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete)	1 Month
Primary	Post-blink Movement	Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement)	Baseline
Primary	Post-blink Movement	Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement)	Dispense
Primary	Post-blink Movement	Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement)	1 Month
Primary	Overall Fit Acceptance	Assessed by investigator based on lens fit alone (0-4 scale; 0=should not be worn, 4=perfect)	Dispense
Primary	Overall Fit Acceptance	Assessed by investigator based on lens fit alone (0-4 scale; 0=should not be worn, 4=perfect)	1 Month
Secondary	Average Hours of Wear Per Day	Number of hours lenses are worn per day	Baseline
Secondary	Average Hours of Wear Per Day	Number of hours lenses are worn per day	1 month
Secondary	Average Comfortable Wearing Time	Typical time of day when subject first experiences lens awareness or irritation.	Baseline
Secondary	Average Comfortable Wearing Time	Typical time of day when subject first experiences lens awareness or irritation	1 Month