Fitting Evaluation of Hydrogel and Silicone Hydrogel Sphere Design Contact Lenses

Fitting Evaluation of Hydrogel and Silicone Hydrogel Sphere Design Contact Lenses.

The aim of this non-dispensing fitting study is to evaluate the short term lens fit, vision performance of three monthly replacement sphere lenses.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Omafilcon A; Device: Somofilcon A; Device: Omafilcon A - Proclear (PC)

Detailed Description

This is a 40-subject, double masked, randomized, bilateral, non-dispensing fitting trial comparing hydrogel and silicone hydrogel lens materials. It is anticipated that this study will involve 2 visits for each lens pair, as follows: Visits: V1 (lens dispensing), V2 (1 hour post lens settling). Each subject will be randomized to wear each pair bilaterally in a series of three short fitting comparisons.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico
    • Optometry Clinic, National Autonomous University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• 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 who is not wearing any of the study lenses.
  • Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)
  • Has a spectacle cylinder up to 0.75D (Diopter) 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 (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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Omafilcon A; Participants are randomized to wear omafilcon A lens pair bilaterally for 1 hour during the study.	Device: Omafilcon A; contact lens
Active Comparator: Somofilcon A; Participants are randomized to wear somofilcon A lens pair bilaterally for 1 hour during the study.	Device: Somofilcon A; contact lens
Active Comparator: Omafilcon A - Proclear (PC); Participants are randomized to wear omafilcon A - PC lens pair bilaterally for 1 hour during the study.	Device: Omafilcon A - Proclear (PC); contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity	High contrast distance visual acuity assessed for each lens pair using LogMAR chart at time of lens insertion, then assessing again 1 hour later with spectacles after lenses are removed.	Baseline (lens insertion), 1 hour
Comfort	Subjective comfort (Scale 0-100: 0=very uncomfortable, 100= very comfortable)	Insertion, 1hr
Lens Centration	Centration of lens on eye (Scale: Optimum, Decentration acceptable, Decentration unacceptable)	Insertion
Lens Centration	Centration of lens on eye (Scale: Optimum, Decentration acceptable, Decentration unacceptable)	1 Hour
Post-blink Lens Movement	Amount of lens movement after blink (Scale: Insufficient, Minimum, Optimum, Moderate, Excessive)	Insertion
Post-blink Lens Movement	Amount of lens movement after blink (Scale: Insufficient, Minimum, Optimum, Moderate, Excessive)	1 Hour
Lens Fit Acceptance	Investigator's determination of whether lens fit is acceptable (Scale: Shouldn't be worn, Borderline, Min Acceptable, OK to dispense, Perfect)	Insertion
Lens Fit Acceptance	Investigator's determination of whether lens fit is acceptable (Scale: Shouldn't be worn, Borderline, Min Acceptable, OK to dispense, Perfect)	1 Hour
Lens Fit Preference	Investigator lens fit preference (Scale: omafilcon A, somofilcon A, omafilcon A - Proclear (PC))	1 Hour
Limbal Redness	Redness of limbal area (Scale: 0-4, 0 = none, 4=severe)	1 Hour
Bulbar Redness	Redness of bulbar conjunctiva (Scale: 0-4, 0 = none, 4=severe)	1 Hour

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): April 11, 2017

Study Registration Dates

• First Submitted: March 28, 2017
• First Submitted That Met QC Criteria: March 28, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): April 9, 2019
• Last Update Submitted That Met QC Criteria: April 1, 2019
• Last Verified: April 1, 2019

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-79

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No