Skip to main content
OpenTrials
Completed

NCT Number: NCT02669095

Clinical Evaluation of Approved and Investigational Contact Lenses

This study is a multi-site, 5-visit dispensing, bilateral double-arm parallel group design, double-masked clinical trial using an investigational contact lens and a marketed contact lens. The objective is to evaluate comfort of the contact lenses when worn on a daily wear modality.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Golden Family Eyecare, Sarasota, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
  • The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
  • The subject must be between 18 to 40 years of age at the time of consent.
  • The subject's vertexed spherical equivalent distance refraction must be in the range of +8.00 to -12.00 in each eye.
  • Subject wears habitual contact lenses a minimum of 4 days per week, eight hours per day.
  • The subject must have best corrected visual acuity of 20/30 or better in each eye.
  • The subject must be a habitual frequent replacement daily wear spherical silicone hydrogel soft contact lens wearer in both eyes.
  • The subject must be able to wear contact lenses for a minimum of 8 hours each day during the study.
  • The subject must have normal eyes (i.e., no ocular medications or infections of any type).

Exclusion criteria

  • Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
  • Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
  • Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
  • Any known sensitive/allergic to Ingredients of OPTI-FREE® PureMoist® solution.
  • Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion.
  • Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.).
  • Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
  • Any ocular infection.
  • Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  • Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.

Treatment and study plan

Investigational Contact Lenses (Test)

Device

Other names: senofilcon C

Marketed Contact Lenses (Control)

Device

Other names: comfilcon A

Primary outcomes

  1. Acceptable Lens Fitting

    Time frame: Up to 4 Week Follow-up

    Lens fit was assessed and recorded for each subject and eye at post lens fitting, 1-, 2-, 3- and 4- week follow-up evaluations. Lens fit was a binary response acceptable and unacceptable lens fit. The proportion of eyes with acceptable lens fitting at post lens fit and across all four follow-ups was combined and reported.

  2. Overall Comfort

    Time frame: Up to 4 Week Follow-up

    Clue comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. CLUE Comfort was assessed at 1-, 2-, 3 and 4- week Follow-up evaluations. The average CLUE comfort score for each lens was reported for each visit.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 29, 2016
Registry last updated
Jun 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.