Clinical Performance of Habitual Wearers of Bioclear 1-day Lenses When Refitted With Biomedics 1-day Extra for 1 Week

NCT02406495 | Completed Results

• 1 other identifier: EX-MKTG-58
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Open label, 1-week daily disposable, dispensing study

Conditions

Myopia; Hyperopia

Outcome Measures

Primary Outcomes (4)

• Lens Fit, Centration - Filcon IV 1 and Ocufilcon D

  Lens fit, centration for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale: optimum, decentration acceptable, and decentration unacceptable

  Baseline and 1 Week

• Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D

  Lens fit, post-blink movement for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).

  Baseline and 1 Week

• Lens Fit, Lens Tightness - Filcon IV 1 and Ocufilcon D

  Lens fit, lens tightness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0%-100% continuous scale 0% - Falls from cornea without lid support 50% - Optimum 100% - No movement

  Baseline and 1 Week

• Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D

  Lens fit, overall fit acceptance for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0-4, 0=Should not be worn, 4=Perfect.

  Baseline and 1 Week

Secondary Outcomes (11)

• Visual Acuity - Filcon IV 1 and Ocufilcon D

  Baseline and 1 Week

• Comfort (Subjective Ratings) - Filcon IV 1 and Ocufilcon D

  Baseline and 1 Week

• Dryness (Subjective Ratings) - Filcon IV 1 and Ocufilcon D

  Baseline and 1 Week

• Handling (Subjective Ratings) - Filcon IV 1 and Ocufilcon D

  Baseline and 1 Week

• Vision Satisfaction (Subjective Ratings) - Filcon IV 1 and Ocufilcon D

  Baseline and 1 Week

Study Arms (1)

filcon IV 1 and ocufilcon D

EXPERIMENTAL

Habitual wearers of filcon IV 1 sphere lenses refitted with asphere ocufilcon D lenses.

Device: filcon IV 1; Device: ocufilcon D

Interventions

filcon IV 1 DEVICE

contact lens

filcon IV 1 and ocufilcon D

ocufilcon D DEVICE

contact lens

filcon IV 1 and ocufilcon D

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Is between 18 and 40 years of age (inclusive)
• Has had a self-reported visual exam in the last two years
• Is an adapted Avaira sphere contact lens wearer (at least 1 week in Avaira sphere)
• Has a contact lens spherical prescription between + 2.25 to - 8.00 (inclusive)
• Has a spectacle cylinder up to 0.75D 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
• Has read, understood and signed the information consent letter.
• Patient contact lens refraction should fit within the available parameters of the study lenses.
• Is willing to comply with the wear schedule (at least 5 days per week, \> 8 hours/day assuming there are no contraindications for doing so).
• Is willing to comply with the visit schedule

You may not qualify if:

• Is not a habitual wearer of Avaira sphere lenses
• Has a CL prescription outside the range of the available parameters of the study lenses.
• Has a spectacle cylinder ≥1.00D of cylinder in either eye.
• Has a history of not achieving comfortable CL wear (5 days per week; \> 8 hours/day)
• Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
• Presence of clinically significant (grade 2-4) anterior segment abnormalities
• Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
• Slit lamp findings that would contraindicate contact lens wear such as:
• Pathological dry eye or associated findings
• 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 (past or present)
• Seborrheic eczema, Seborrheic conjunctivitis
• History of corneal ulcers or fungal infections

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

Optometry Research Group (GIO) Optics Department, University of Valencia

Valencia, 46100, Spain

Location

MeSH Terms

Conditions

Myopia; Hyperopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Jose A. Vega, OD, Sr. Manager Global Medical Scientific Affairs
• Organization: Coopervision

javega@coopervision.com

(925) 621-3761

Study Officials

• Robert Montés-Mico, OD MPhil PhD

  Optometry Research Group (GIO) Optics Department, University of Valencia

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2015
• First Posted: April 2, 2015
• Study Start: April 1, 2015
• Primary Completion: April 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 29, 2020
• Results First Posted: May 3, 2016

Record last verified: 2020-07

Locations

ES (1)