Fitting Evaluation of Hydrogel and Silicone Hydrogel Sphere Design Contact Lenses

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Somofilcon A; Device: Omafilcon A; Device: Omafilcon A - Proclear (PC)

• Registration Number: NCT03098745
• Lead Sponsor: Coopervision, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2017-02-01
• Primary Completion: 2017-03-01
• Study First Submitted: 2017-03-28
• Study First Submitted QC: 2017-03-28
• Study First Posted: 2017-04-04
• Study Completion: 2017-04-11
• Results First Submitted: 2018-03-27
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-01
• Last Update Submitted: 2019-04-01
• Results First Posted: 2019-04-09
• Last Update Posted: 2019-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Somofilcon A	Somofilcon A	Participants are randomized to wear somofilcon A lens pair bilaterally for 1 hour during the study.
Omafilcon A	Omafilcon A	Participants are randomized to wear omafilcon A lens pair bilaterally for 1 hour during the study.
Omafilcon A - Proclear (PC)	Omafilcon A - Proclear (PC)	Participants are randomized to wear omafilcon A - PC lens pair bilaterally for 1 hour during the study.

Primary Outcome Measures

Name	Time	Method
Lens Centration	1 Hour	Centration of lens on eye (Scale: Optimum, Decentration acceptable, Decentration unacceptable)
Bulbar Redness	1 Hour	Redness of bulbar conjunctiva (Scale: 0-4, 0 = none, 4=severe)
Visual Acuity	Baseline (lens insertion), 1 hour	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.
Comfort	Insertion, 1hr	Subjective comfort (Scale 0-100: 0=very uncomfortable, 100= very comfortable)
Post-blink Lens Movement	1 Hour	Amount of lens movement after blink (Scale: Insufficient, Minimum, Optimum, Moderate, Excessive)
Lens Fit Acceptance	1 Hour	Investigator's determination of whether lens fit is acceptable (Scale: Shouldn't be worn, Borderline, Min Acceptable, OK to dispense, Perfect)
Lens Fit Preference	1 Hour	Investigator lens fit preference (Scale: omafilcon A, somofilcon A, omafilcon A - Proclear (PC))
Limbal Redness	1 Hour	Redness of limbal area (Scale: 0-4, 0 = none, 4=severe)

Trial Locations

Locations (1)

Optometry Clinic, National Autonomous University; 🇲🇽 Mexico City, Mexico