Clinical Performance of Toric Hydrogel Contact Lenses Following One Week of Daily Wear

The aim of this prospective study is to evaluate the clinical performance of filcon IV1 toric and ocufilcon D toric contact lenses after 1 week of wear in each pair.

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: filcon IV1 toric lens; Device: ocufilcon D toric lens

Detailed Description

This is a 30-subject, prospective, randomized, double masked, bilateral, 1 week cross-over study comparing the fitting characteristics of filcon IV1 toric lenses against ocufilcon D hydrogel toric lenses.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Mexico D.F., Mexico
    • Optometry Clinic, National Autonomous University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A person is eligible for inclusion in the study if he/she:

  • 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 toric 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 -2.00 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 -2.00 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. Confidential EX-MKTG-66 Clinical Performance of Toric Hydrogel Contact Lenses Following One Week of Daily Wear 10

  • 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: filcon IV1 toric lens; Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.	Device: filcon IV1 toric lens; toric contact lens
Active Comparator: ocufilcon D toric lens; Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.	Device: ocufilcon D toric lens; toric contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Fit Acceptance	Investigator's preference for lens fit acceptance for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. Scale 0-4, 0=should not be worn, 1=borderline but unacceptable, 2= minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect	Baseline and 1 week
Lens Centration	Lens centration for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. (Centered - optimal, decentered slightly, or substantially decentered).	Baseline and 1 week
Post-blink Movement	Post-blink movement for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. Scale 0-4, 0=insufficient, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement.	Baseline and 1 week
Overall Stability	Overall lens stability for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. Scale 0-4, 0=very poor stability, 4=excellent stability.	Baseline and 1 week
Corneal Coverage	Corneal coverage for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. (yes=full corneal coverage or no=not full coverage)	Baseline and 1 week
Lens Orientation in Primary Position of Gaze	Lens rotation for habitual toric lens assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week with slit lamp by measuring within 10 degrees of the axis mark on the lens relative to the desired 6' o'clock position while the subject looked straight ahead.	Baseline and 1 week
Rotational Recovery in Degrees After 60 Seconds	Rotational recovery measured in degrees after 60 seconds for habitual toric lens assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and at 1 week by slit lamp.	Baseline and 1 week

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Velázquez Guerrero, MSc., FIACLE, School of Optometry, National Autonomous University (UNAM)

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: July 25, 2016
• First Submitted That Met QC Criteria: July 25, 2016
• First Posted (Estimate): July 28, 2016

Study Record Updates

• Last Update Posted (Actual): May 8, 2017
• Last Update Submitted That Met QC Criteria: March 28, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: EX-MKTG-66

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO