Evaluation of Comfilcon A and Senofilcon A Lenses

NCT01695369 | Completed Results

• 1 other identifier: CV-12-54
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of Comfilcon A and Senofilcon A Lenses

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• Subjective Responses for Comfort Rated on a 0-100 Visual Scale.

  Subjective Patient Ratings measured using a Visual Analog Scale on a 0-100. (0=Cannot be worn. Causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever)

  Baseline Insertion, 10 Minutes, 5 hours and 10 hours

Study Arms (2)

Senofilcon A

ACTIVE COMPARATOR

Senofilcon A; Comfilcon A

Device: Senofilcon A; Comfilcon A; Device: Comfilcon A; Senofilcon A

Comfilcon A

EXPERIMENTAL

Comfilcon A; Senofilcon A

Device: Senofilcon A; Comfilcon A; Device: Comfilcon A; Senofilcon A

Interventions

Senofilcon A; Comfilcon A DEVICE

Senofilcon A; Comfilcon A

Comfilcon A; Senofilcon A

Comfilcon A; Senofilcon A DEVICE

Comfilcon A; Senofilcon A

Comfilcon A; Senofilcon A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has had an oculo-visual examination in the last two years
• Is at least 18 years of age and has full legal capacity to volunteer
• Has read and understood the information consent letter
• Is willing and able to follow instructions and maintain the appointment schedule
• Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual vision correction
• Currently wears soft contact lenses at least 3 days a week, 8 hours a day
• Has clear corneas and no active ocular disease
• Has not worn lenses for at least 12 hours before the examination
• Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
• No amblyopia
• No evidence of lid abnormality or infection (e.g. entropion, ectropion, chalazia, recurrent styes)
• No clinically significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 2 or above: corneal edema, tarsal abnormalities, and conjunctival injection).
• No other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea \[infiltrates\], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology)
• No aphakia
• Has prescription to match the available power range.

You may not qualify if:

• Greater than 0.75 of refractive astigmatism in either eye
• Has never worn contact lenses before
• Wears contact lenses on an extended wear basis
• Has any systemic disease affecting ocular health
• Is a known sufferer of ocular allergies
• Is taking medication, such as oral antihistamines, antihistamine eye drops, oral and ophthalmic beta-adrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, oral steroids and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants
• Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities
• Is aphakic
• Has undergone corneal refractive surgery.
• Is wearing monovision
• Is participating in any other type of clinical or research study
• Female who is currently pregnant or is breast-feeding
• Has \> grade 1 ocular corneal staining in both type and extent by \> grade 2 in either type or extent

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

University of Houston College of Optometry, TERTC

Houston, Texas, 77204, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Jan Bergmanson, OD,PhD
• Organization: University of Houston, College of Optometry, TERTC

jbergmanson@uh.edu

713-743-1950

Study Officials

• Jan Bergmanson, OD, PhD

  University of Houston College of Optometry, TERTC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2012
• First Posted: September 28, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: July 28, 2020
• Results First Posted: March 6, 2014

Record last verified: 2020-07

Locations

US (1)