A Clinical Comparison of Three Soft Daily Disposable Contact Lenses

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: somofilcon A; Device: nelfilcon A II 2; Device: omafilcon A ll 2

• Registration Number: NCT02920983
• Lead Sponsor: Coopervision, Inc.

Brief Summary

This study aims to compare the clinical performance of the somfilcon A, nelfilcon A II 2 and omafilcon A II 2 daily disposable contact lenses.

Detailed Description

This will be a randomised, subject-masked, crossover, bilateral study, controlled by cross comparison. Fifty subjects will use each lens type for a week in random sequence. Follow-up visits for each lens will be performed after one week of wear. Lenses will be worn on a daily wear, daily disposable wear schedule.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-29
• Study First Submitted QC: 2016-09-29
• Study First Posted: 2016-09-30
• Primary Completion: 2016-11
• Study Completion: 2017-02
• Results First Submitted: 2017-10-17
• Results First Submitted QC: 2019-04-01
• Results First Posted: 2019-06-26
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-15
• Last Update Posted: 2019-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Subjects will only be eligible for the study if:

  1. They are of legal age (18) and capacity to volunteer.
  2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
  3. They are willing and able to follow the protocol.
  4. They agree not to participate in other clinical research for the duration of this study.
  5. They have a contact lens spherical prescription between -1.00 to - 6.00D (Diopters) (inclusive)
  6. They have a spectacle cylindrical correction of -0.75D or less in each eye.
  7. At dispensing, they can attain at least 0.10 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
  8. They currently use soft contact lenses or have done so in the previous six months.
  9. They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).

Exclusion Criteria

• Subjects will not be eligible to take part in the study if:

  1. They have an ocular disorder which would normally contra-indicate contact lens wear.
  2. They have a systemic disorder which would normally contra-indicate contact lens wear.
  3. They are using any topical medication such as eye drops or ointment.
  4. They have had cataract surgery.
  5. They have had corneal refractive surgery.
  6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
  7. They are pregnant or breast-feeding.
  8. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
  9. They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
  10. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
somofilcon A	somofilcon A	Subjects are randomized to wear somofilcon A for one week during the cross over study.
nelfilcon A II 2	nelfilcon A II 2	Subjects are randomized to wear nelfilcon A II 2 for one week during the cross over study.
omafilcon A ll 2	omafilcon A ll 2	Subjects are randomized to wear omafilcon A ll 2 for one week during the cross over study.

Primary Outcome Measures

Name	Time	Method
Ocular Physiology	1 week	Ocular physiology assessment of by biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

Secondary Outcome Measures

Name	Time	Method
Lens Fit - Horizontal Centration	1 week	Horizontal centration will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal.
Lens Fit - Movement	1 week	Lens movement assessed using the following evaluations: extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.
Lens Fit - Corneal Coverage	1 week	Corneal coverage will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.
Lens Surface - Deposition	1 week	Lens surface will be assessed using Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe
Lens Surface - Wettability	1 week	Lens wettability will be assessed using Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe
Visual Acuity	1 week	Visual acuity will be assessed by LogMAR.
Lens Fit - Vertical Centration	1 week	Vertical centration will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.

Trial Locations

Locations (1)

Eurolens Research - The University of Manchester; 🇬🇧 Manchester, United Kingdom