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

NCT03418064 | Completed Results FDA Device

• 1 other identifier: EX-MKTG-90
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (11)

• Lens Centration

  Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable)

  Baseline

• Lens Centration

  Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable)

  Dispense

• 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

• Corneal Coverage

  Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete)

  Baseline

• Corneal Coverage

  Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete)

  Dispense

• Corneal Coverage

  Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete)

  1 Month

• 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

• 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

• 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

• Overall Fit Acceptance

  Assessed by investigator based on lens fit alone (0-4 scale; 0=should not be worn, 4=perfect)

  Dispense

• Overall Fit Acceptance

  Assessed by investigator based on lens fit alone (0-4 scale; 0=should not be worn, 4=perfect)

  1 Month

Secondary Outcomes (4)

• Average Hours of Wear Per Day

  Baseline

• Average Hours of Wear Per Day

  1 month

• Average Comfortable Wearing Time

  Baseline

• Average Comfortable Wearing Time

  1 Month

Study Arms (2)

fanfilcon A toric

EXPERIMENTAL

Subjects who wore fanfilcon A toric contact lens, either as the first or second lens in this cross-over study.

Device: Fanfilcon A toric lens

lotrafilcon B

ACTIVE COMPARATOR

Subjects who wore lotrafilcon B toric contact lens, either as the first or second lens in this cross-over study.

Device: Lotrafilcon B toric lens

Interventions

Fanfilcon A toric lens DEVICE

Contact lens

Also known as: Avaira Vitality toric lens

fanfilcon A toric

Lotrafilcon B toric lens DEVICE

Contact lens

Also known as: AIR OPTIX for Astigmatism

lotrafilcon B

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

Optometry Clinic, National Autonomous University

Mexico City, Mexico

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Jose A. Vega, O.D., MSc., FAAO
• Organization: CooperVision

jvega2@coopervision.com

19256213761

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: February 1, 2018
• Study Start: February 10, 2018
• Primary Completion: May 16, 2018
• Study Completion: May 16, 2018
• Last Updated: November 13, 2019
• Results First Posted: November 13, 2019

Record last verified: 2019-10

Locations

ME (1)