The Clinical Comparison of Senofilcon A and Stenfilcon A Contact Lenses

NCT02643004 | Completed Results

• 1 other identifier: EX-MKTG-62
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to compare the clinical performance of senofilcon A lens with the stenfilcon A lens each for one week of daily disposable wear.

Conditions

Myopia

Outcome Measures

Primary Outcomes (5)

• Ocular Physiology

  Ocular physiology assessment of senofilcon A and stenfilcon A lenses by biomicroscopy for the following: corneal staining, conjunctival hyperaemia, limbal hyperaemia, and conjunctival staining. Scale 0-4, 0.25 steps, 0=normal, 4=severe.

  Baseline and 1 week

• Overall Subjective Score of Lenses

  Subjective responses will be evaluated for each pair using questionnaire. Scale 0-100, 0=extremely poor, 100=excellent.

  Baseline and 1 week

• Comfort

  Subjective responses for comfort will be evaluated for each pair using questionnaire. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.

  Baseline and 1 week

• Dryness

  Subjective responses for dryness will be evaluated for each pair using questionnaire. Scale 0-100, 0=extremely poor, high levels of dryness, 100=excellent, no dryness.

  1 week

• Vision

  Subjective responses for vision will be evaluated for each pair using questionnaire. Scale 0-100, 0=unacceptable, lens cannot be worn, 100=excellent.

  Baseline and 1 week

Secondary Outcomes (13)

• Horizontal Centration

  Baseline

• Horizontal Centration

  1 Week

• Vertical Centration

  Baseline

• Vertical Centration

  1 Week

• Lens Movement

  Baseline

Study Arms (2)

Senofilcon A

ACTIVE COMPARATOR

Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.

Device: Senofilcon A

Stenfilcon A

ACTIVE COMPARATOR

Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.

Device: Stenfilcon A

Interventions

Senofilcon A DEVICE

contact lens

Senofilcon A

Stenfilcon A DEVICE

contact lens

Stenfilcon A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will only be eligible for the study if:
• They are of legal age (18) and capacity to volunteer.
• They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
• They are willing and able to follow the protocol.
• They agree not to participate in other clinical research for the duration of this study.
• They have a contact lens spherical prescription between -1.00 to - 6.00D (inclusive)
• They have a spectacle cylindrical correction of -0.75D or less in each eye.
• 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.
• They currently use soft contact lenses or have done so in the previous six months.
• They are willing to comply with the wear schedule (at least six days per week and for at least eight hours per day).

You may not qualify if:

• Subjects will not be eligible to take part in the study if:
• They have an ocular disorder which would normally contra-indicate contact lens wear.
• They have a systemic disorder which would normally contra-indicate contact lens wear.
• They are using any topical medication such as eye drops or ointment.
• They have had cataract surgery.
• They have had corneal refractive surgery.
• They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
• They are pregnant or lactating.
• They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
• 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.
• They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
• They currently wear either MyDay (daily) or the Acuvue Oasys (2 weekly) lens.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

Eurolens Research - The University of Manchester

Manchester, M13 9PL, United Kingdom

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Sr. Manager Global Medical Scientific Affairs
• Organization: CooperVision Inc.

javega@coopervision.com

(925) 621-3761

Study Officials

• Carole Maldonado-Codinal, PhD

  Eurolens Research, University of Manchester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2015
• First Posted: December 30, 2015
• Study Start: December 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: May 1, 2016
• Last Updated: August 23, 2017
• Results First Posted: March 31, 2017

Record last verified: 2017-07

Locations

GB (1)