Performance of Two Toric Silicone Hydrogel Contact Lenses

Astigmatism Clinical Trial

Official title:

Performance of Toric Silicone Hydrogel Contact Lenses Following Two Weeks of Daily Wear

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03578926
• Other study ID #: EX-MKTG-93
• Status: Completed
• Phase: N/A
• Start date: June 18, 2018
• Est. completion date: October 8, 2018

Study information

• Verified date: November 2019
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective study to evaluate the clinical performance of fanfilcon A toric contact lens and senofilcon A toric contact lens after two weeks of wear.

Description:

The aim of this prospective study is to evaluate the clinical performance of Avaira Vitality toric and ACUVUE OASYS® for ASTIGMATISM contact lenses after 2‐weeks of wear in each pair.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 8, 2018
• Est. primary completion date: October 8, 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:

• 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
• senofilcon A 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 (Optimum, Decentration acceptable, Decentration unacceptable)	Baseline
Primary	Lens Centration	Centration of lens on eye (Optimum, Decentration acceptable, Decentration unacceptable)	2 weeks
Primary	Corneal Coverage	Lens covering the cornea (Yes, No)	Baseline
Primary	Corneal Coverage	Lens covering the cornea (Yes, No)	2 weeks
Primary	Post Blink Movement	Amount of lens movement after blink (0-5 Likert Scale, 0=Insufficient, 2=Optimal, 4=Excessive movement)	Baseline
Primary	Post Blink Movement	Amount of lens movement after blink (0-5 Likert Scale, 0=Insufficient, 2=Optimal, 4=Excessive movement)	2 weeks
Secondary	Wearing Time	Average daily wearing time (hours/day)	2 weeks
Secondary	Comfortable Wearing Time	Comfortable daily wearing time (hours/day)	2 weeks