Assessment of Daily Disposable Silicone Hydrogel Lens Wear

NCT01093625 | Completed Results

• 1 other identifier: CR-0916
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect of an investigational silicone hydrogel soft contact lens on new contact lens wearers (neophytes) compared to a control of spectacle wearers.

Conditions

Myopia

Outcome Measures

Primary Outcomes (7)

• Papillary Conjunctivitis

  Swelling of the papillary (Papillary conjunctivitis) area of the eye was assessed using a slit-lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.

  1 Year

• Conjunctival Hyperemia

  Comparison of the amount of redness in the conjunctival area of the eye, between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.

  1 Year

• Limbal Hyperemia

  Swelling of the vessels in the limbal area of the eye using a slit lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.

  1 Year

• Corneal Staining

  Abrasions in the cornea area of the eye using a slit lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments.

  1 Year

• Conjunctival Staining

  Mild abrasions of the conjunctival area of the eye. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.

  1 Year

• Corneal Neovascularization

  New vascularization of the Cornea. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.

  1 Year

• Differences in Subjective Comfort From the Contact Lens User Experience (CLUE) Questionnaire

  The subjective comfort questionnaire CLUE, assesses the overall lens comfort. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores 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. The differences between: (final visit and first visit) and then (final visit and 6 months) are reported.

  1 Year

Secondary Outcomes (1)

• Comfortable Wearing Time

  1 Year

Study Arms (2)

Narafilcon B Contact Lens

EXPERIMENTAL

Investigational Silicone Hydrogel Contact Lens

Device: Narafilcon B Contact Lens

Spectacles

ACTIVE COMPARATOR

Device: Spectacles

Interventions

Narafilcon B Contact Lens DEVICE

Also known as: Investigational Silicone Hydrogel

Narafilcon B Contact Lens

Spectacles DEVICE

spectacle wearers

Spectacles

Eligibility Criteria

• Age: 15 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Able to read, comprehend and sign an informed consent (or parental consent/subject assent, as appropriate).
• Willing to comply with the study visit schedule.
• Ages 15 to 39.
• Has access to a cellular telephone with text messaging capabilities.
• Has a current pair of spectacles.
• 'Neophyte' - In this work, 'neophyte' will be taken to mean any subject who has never been dispensed contact lenses. A subject who has taken part in a non-dispensing clinical study or has been fitted with contact lenses in practice but never went on to actually wear the lenses, will also be classified as a 'neophyte'.
• Spherical contact lens (CL) prescription between -0.75D and -6.00D and spectacle cylinder equal to or less than 0.75 DC.
• Monocular best-corrected distance visual acuity (VA) ≥ 20/30 Snellen in each eye.
• Subject agrees to "intent" of wearing the CLs at minimum 6 hours/day for at least 4 days per week.
• They agree not to participate in other clinical research during the duration of this study.

You may not qualify if:

• Active ocular allergy, infection, injury, inflammation, or abnormality (e.g., keratoconus) that might interfere with soft contact lens wear.
• Prior corneal refractive surgery or corneal irregularity (e.g., keratoconus).
• Systemic disease, which might interfere with contact lens wear.
• Medication usage that may be associated with eye dryness.
• Use of any topical medication such as eye drops or ointment.
• Pregnant or lactating (by self-report).
• Aphakia.
• Grade 2 or greater of any of the following ocular surface signs: corneal edema, corneal vascularization, corneal staining, tarsal conjunctival changes or any other abnormality, which would normally contraindicate contact lens wear.
• Have participated in any other clinical trial or research in the two weeks prior to starting this study.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead
• Ohio State University: collaborator

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Myopia

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Results Point of Contact

• Title: Katherine E. Osborn
• Organization: Vistakon

clinicalstudies@its.jnj.com

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: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2010
• First Posted: March 26, 2010
• Study Start: January 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: June 19, 2018
• Results First Posted: February 13, 2014

Record last verified: 2015-05

Locations

US (1)