Non-dispensing Fitting Study Comparing the Clinical Performance Hydrogel Sphere Design Contact Lenses.

The aim of this non-dispensing study is to evaluate the clinical performance of different hydrogel contact lens designs.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: filcon IV I (BC 8.6); Device: ocufilcon D; Device: filcon IV I (BC 8.7); Device: methafilcon A (BC 8.6); Device: methafilcon A (BC 8.7); Device: somofilcon A

Detailed Description

This is a 35-subject, double masked, randomized, contra lateral, non-dispensing fitting trial comparing different hydrogel lens materials. For each study, this study will involve 2 visits: lens dispensing (baseline) and 1 hour post lens settling. Each subject will be randomized to wear the test and control lenses, in the right or left eye, in a series of four short fitting comparisons as follows:

Pair 1 (P1): filcon IV I (Base Curve (BC) 8.6) and ocufilcon D

Pair 2 (P2): filcon IV I (Base Curve (BC) 8.7) and ocufilcon D

Pair 3 (P3): methafilcon A (Base Curve (BC) 8.6) and ocufilcon D

Pair 4 (P4): methafilcon A (Base Curve (BC)8.7) and somofilcon A

• Study Type: Interventional
• Enrollment (Actual): 35
• 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 CL (Contact Lens) wearer.
• Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)
• Has a spectacle cylinder up to 0.75D (Diopters) in each eye.
• 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.
• Is willing to comply with the visit schedule.

Exclusion Criteria:

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

• Has never worn contact lenses before.
• Currently wears rigid gas permeable contact lenses.
• Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
• Has a CL prescription outside the range of - 1.00 to - 6.00D
• Has a spectacle cylinder ≥1.00D of cylinder in either eye.
• 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 (GPC) 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: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: filcon IV I (BC 8.6) / ocufilcon D (pair one); Participants were randomized to a test and control lens for each pair in a contralateral design.	Device: filcon IV I (BC 8.6); control lens; Device: ocufilcon D; test lens
Experimental: filcon IV I (BC 8.7) / ocufilcon D (pair two); Participants were randomized to a test and control lens for each pair in a contralateral design.	Device: ocufilcon D; test lens; Device: filcon IV I (BC 8.7); control lens
Experimental: methafilcon A (BC 8.6) / ocufilcon D (pair three); Participants were randomized to a test and control lens for each pair in a contralateral design.	Device: ocufilcon D; test lens; Device: methafilcon A (BC 8.6); control lens
Experimental: methafilcon A (BC 8.7) / somofilcon A (pair four); Participants were randomized to a test and control lens for each pair in a contralateral design.	Device: methafilcon A (BC 8.7); control lens; Device: somofilcon A; test lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Centration - Pair One	Centration for filcon IV I (Base Curve (BC) 8.6) / ocufilcon D (pair one) is assessed. (optimum, decentration acceptable, decentration unacceptable).	Baseline and 1 hour
Centration - Pair Two	Centration for filcon IV I (Base Curve (BC) 8.7) / ocufilcon D (pair two) is assessed. (optimum, decentration acceptable, decentration unacceptable).	Baseline and 1 hour
Centration - Pair Three	Centration for methafilcon A (Base Curve (BC) 8.6) / ocufilcon D (pair three) is assessed. (optimum, decentration acceptable, decentration unacceptable).	Baseline and 1 hour
Centration - Pair Four	Centration for methafilcon A (Base Curve (BC) 8.7) / somofilcon A (pair four) is assessed. (optimum, decentration acceptable, decentration unacceptable).	Baseline and 1 hour
Post-blink Movement - Pair One	Post-blink movement for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).	Baseline
Post-blink Movement - Pair One	Post-blink movement for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).	1 hour
Post-blink Movement - Pair Two	Post-blink movement for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).	Baseline
Post-blink Movement - Pair Two	Post-blink movement for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).	1 hour
Post-blink Movement - Pair Three	Post-blink movement for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).	Baseline
Post-blink Movement - Pair Three	Post-blink movement for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).	1 hour
Post-blink Movement - Pair Four	Post-blink movement for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).	Baseline
Post-blink Movement - Pair Four	Post-blink movement for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).	1 hour
Lens Tightness - Pair One	Lens tightness on push on test for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)	Baseline and 1 hour
Lens Tightness - Pair Two	Lens tightness on push on test for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)	Baseline and 1 hour
Lens Tightness - Pair Three	Lens tightness on push on test for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)	Baseline and 1 hour
Lens Tightness - Pair Four	Lens tightness on push on test for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)	Baseline and 1 hour
Overall Fit Preference - Pair One	Investigator's lens fit acceptance / acceptability for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. Three choices: filcon IV I (BC 8.6), ocufilcon D, or no preference.	Baseline and 1 hour
Overall Fit Acceptance - Pair Two	Investigator's lens fit acceptance / acceptability for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. Three choices: filcon IV I (BC 8.7), ocufilcon D, or no preference.	Baseline and 1 hour
Overall Fit Acceptance - Pair Three	Investigator's lens fit acceptance / acceptability for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. Three choices: methafilcon A (BC 8.6), ocufilcon D, or no preference.	Baseline and 1 hour
Overall Fit Acceptance - Pair Four	Investigator's lens fit acceptance / acceptability for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. Three choices: methafilcon A (BC 8.7), somofilcon A, or no preference.	Baseline and 1 hour

Collaborators and Investigators

• Sponsor: CooperVision, Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: March 30, 2016
• First Submitted That Met QC Criteria: March 30, 2016
• First Posted (Estimate): April 5, 2016

Study Record Updates

• Last Update Posted (Actual): February 6, 2018
• Last Update Submitted That Met QC Criteria: July 20, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Refractive Errors; Seizures; Myopia
• Other Study ID Numbers: EX-MKTG-65

Plan for Individual participant data (IPD)

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