Performance Comparison Between Fanfilcon A and Senofilcon A Sphere Lenses

NCT02956460 | Completed Results

• 1 other identifier: EX-MKTG-73
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 4

Brief Summary

Prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, 1 month dispensing study (2 weeks each lens pair)

Conditions

Myopia

Outcome Measures

Primary Outcomes (11)

• Overall Comfort

  Subjective assessment for comfort is assessed. Scale 0-10, 0=painful, 10=can't feel

  2 weeks

• Overall Dryness

  Subjective ratings for dryness is assessed on a scale of 0-10, 0=extremely dry, 10=no dryness

  2 weeks

• Vision Quality

  Subjective ratings of vision quality is assessed on a scale 0-10, 0=not sharp/not clear, 10=sharp/clear

  2 weeks

• Lens Handling

  Subjective ratings of lens handling - insertion and removal - is assessed using scale 0-10, 0=difficult to handle, 10=very easy to handle

  2 weeks

• Vision Satisfaction

  Subjective ratings of vision satisfaction is assessed on a scale 0-10, 0=completely dissatisfied, 10=completely satisfied.

  2 weeks

• Lens Centration

  Lens centration will be recorded by degree and direction in the primary position. (Optimum, decentration acceptable, decentration unacceptable).

  2 weeks

• Conjunctival Staining

  Assessed using slit lamp with blue light and sodium fluorescein, low medium magnification. 0=None, no staining present 1. Very slight 2. Slight 3. Moderate 4. Severe

  2 weeks

• Smoothness

  Subjective ratings for lens sensation of smoothness is assessed on a scale 0-10, 0=not smooth at all, 10=totally smooth

  2 weeks

• Clean Feeling

  Subjective ratings for lens clean feeling is assessed on a scale 0-10, 0=not clean at all, 10=lenses feel perfectly clean

  2 weeks

• Lens Hydrated

  Subjective ratings for lens sensation is assessed on a scale 0-10, 0=totally dehydrated, 10=totally hydrated

  2 weeks

• Lens Wettability

  Subjective ratings for lens wettability is assessed on a scale 0-10, 0=non-wettable, 10=highly wettable

  2 weeks

Study Arms (2)

fanfilcon A

ACTIVE COMPARATOR

Participants are randomized to wear fanfilcon A for two weeks during the cross over study.

Device: fanfilcon A

senofilcon A

ACTIVE COMPARATOR

Participants are randomized to wear senofilcon A for two weeks during the cross over study.

Device: senofilcon A

Interventions

fanfilcon A DEVICE

contact lens

fanfilcon A

senofilcon A DEVICE

contact lens

senofilcon A

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is between 18 and 40 years of age (inclusive)
• Has read, understood and signed the information consent letter
• Has had a self-reported eye exam in the last two years
• Is a spherical soft contact lens wearer
• Has a contact lens prescription that fits within the available parameters of the study lenses
• Has a spectacle cylinder no greater than 0.75D (Diopters) 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
• Is willing and anticipated to be able to comply with the wear schedule (8 hours per day; 5 days a week of lens wear)
• Is willing and able to follow instructions and maintain the appointment schedule

You may not qualify if:

• A person will be excluded from the study if he/she:
• Has a history of not achieving comfortable CL (Contact Lens) wear (defined as 5 days per week; \>8 hours/day)
• Is currently wearing senofilcon C (2 weeks lens), senofilcon A 1-Day, senofilcon C (monthly lens) or enfilcon A contact lenses
• Is habitually using rewetting/ lubricating eye drops more than once per day
• Presents with clinically significant anterior segment abnormalities
• Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear
• Presents with slit lamp findings that would contraindicate contact lens wear such as:
• Pathological dry eye or associated findings
• Significant 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 (or history in past year)
• Seborrheic eczema of eyelid region, Seborrheic conjunctivitis
• History of corneal ulcers or fungal infections
• Poor personal hygiene

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (4)

Eric M. White O. D., Inc

San Diego, California, 92123, United States

Location

Golden Vision

Sarasota, Florida, 34232, United States

Location

Kannarr Eye Care

Pittsburg, Kansas, 66762, United States

Location

Nittany Eye Associates

State College, Pennsylvania, 16801, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Jose Vega, O.D., MSc., FAAO
• Organization: CooperVision

JVega2@coopervision.com

925-621-3761

Study Officials

• Lyndon Jones, PhD, FAAO

  Centre for Contact Lens Research

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: November 7, 2016
• Study Start: October 27, 2016
• Primary Completion: December 14, 2016
• Study Completion: December 14, 2016
• Last Updated: April 2, 2018
• Results First Posted: December 8, 2017

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)