Comparative Study of Two Marketed 1-day Soft Contact Lenses

NCT01464255 | Completed Results

• 1 other identifier: CV-OMC-01
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate ocufilcon D lens compared to ocufilcon B lens in a 1-week crossover, daily wear regimen.

Conditions

Myopia

Keywords

contact lenses

Outcome Measures

Primary Outcomes (6)

• Lens Fit - Decentration After Insertion

  The ophthalmologist's objective assessment of lens fit measurement of decentration after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (mm, horizontal and vertical).

  Baseline and 7 days from baseline visit

• Lens Fit - Decentration at One Week

  The ophthalmologist's objective assessment of lens fit measurement of decentration of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). Each pair worn for one week daily disposable wear basis (at least 8 hours per day, 7 days per week). Lenses worn minimum 2 hours prior to visit. (mm, horizontal and vertical).

  7 days and 14 days from baseline visit

• Lens Fit - Tightness After Insertion

  The ophthalmologist's rating of lens fit measurement of push-up tightness after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (0-100%, 5% steps, 0%=excessively loose, 50%=optimum, 100%=excessively tight ).

  Baseline and 7 days from baseline visit

• Lens Fit - Tightness at One Week

  The ophthalmologist's rating of lens fit measurement of push-up tightness of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). Each pair worn for one week daily disposable wear basis (at least 8 hours per day, 7 days per week). Lenses worn minimum 2 hours prior to visit. (0-100%, 5% steps, 0%=excessively loose, 50%=optimum, 100%=excessively tight ).

  7 days and 14 days from baseline visit

• Lens Fit - Post-Blink Lens Movement After Insertion

  The ophthalmologist's objective assessment of lens fit measurement of post-blink lens movement after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (mm).

  Baseline and 7 days from baseline visit

• Lens Fit - Post-Blink Lens Movement Prior to Removal

  The ophthalmologist's objective assessment of lens fit measurement of post-blink lens movement prior to removal of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). (mm).

  7 days and 14 days from baseline visit

Secondary Outcomes (7)

• Overall Preference - Comfort After Insertion

  14 days from baseline visit

• Overall Preference - Comfort Before Removal

  14 days from baseline visit

• Overall Preference - Dryness After Insertion

  14 days from baseline visit

• Overall Preference - Dryness Before Removal

  14 days from baseline visit

• Overall Preference - Handling, Inserting

  14 days from baseline visit

Study Arms (2)

ocufilcon D

EXPERIMENTAL

Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.

Device: ocufilcon B

ocufilcon B

ACTIVE COMPARATOR

Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.

Device: ocufilcon D

Interventions

ocufilcon D DEVICE

Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.

Also known as: oculfilcon D (Daily wear soft contact lens)

ocufilcon B

ocufilcon B DEVICE

Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.

Also known as: oculfilcon B (Daily wear soft contact lens)

ocufilcon D

Eligibility Criteria

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

You may qualify if:

• Has had a self reported oculo-visual examination in the last two years.
• Is able to wear the study lenses for at least eight hours a day, seven days a week
• Aged 18-40 years and has full legal capacity as a volunteer
• Has a distance contact lens prescription from -0.25 and -6.00D inclusive
• Has spectacle astigmatism of \< 1.00D in each eye
• Baseline vision of 20/20 best-corrected in each eye.
• Is correctable to at least 20/25 distance visual acuity with study contact lenses in each eye
• Has read and understood the consent form and willing to sign consent form
• Willing and able to follow participant instructions and attend the required study visits Has worn soft contact lenses for at least two weeks prior to the study (daily wear only).

You may not qualify if:

• Currently wears contact lenses on an extended wear basis.
• Not a current or past wearer of the ocufilcon B 52% 1-day lenses.
• Has undergone anterior ocular surgery
• Is aphakic
• Has never worn contact lenses before
• Has any systemic disease which clinically contraindicates contact lenses
• Has active ocular disease or severe insufficiency of lacrimal secretion (dry eye)
• Use of systemic or topical medications that will affect ocular health or visual performance
• Slit lamp findings with a grading of greater than 1.0 using the grading scales in Appendix 3
• Not possible to achieve a satisfactory fit with the lens design used in the study
• Has keratoconus or other corneal irregularity
• Participating in another eye-related clinical trial
• Pregnant, lactating or planning a pregnancy

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

Clinical Research Center, U.C. Berkeley, School of Optometry

Berkeley, California, 94720-, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Thao N Yeh, O.D.
• Organization: Clinical Research Center, University of California, Berkeley, School of Optometry

thaoyeh@berkeley.edu

(510) 642-9649

Study Officials

• Thao N Yeh, OD

  U.C. Berkeley, School of Optometry

  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
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2011
• First Posted: November 3, 2011
• Study Start: August 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: November 1, 2011
• Last Updated: August 19, 2014
• Results First Posted: August 19, 2014

Record last verified: 2014-08

Locations

US (1)