Subjective Evaluation of a Commercially Marketed Contact Lens Amongst a Subset of the Contact Lens Wearing Population

NCT01007916 | Completed Results

• 1 other identifier: P-336-C-016
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the performance of commercially marketed contact lenses to habitual contact lenses in a selected segment of the contact lens wearing population.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• Comfort Upon Insertion

  Comfort upon insertion, as interpreted by the participant, was recorded on a questionnaire by the participant using a 10-point scale, with 1 being poor and 10 being excellent. Comfort upon insertion was assessed as a single, retrospective evaluation of 4-weeks' wear time.

  4 weeks of wear

Study Arms (2)

Lotrafilcon B / Habitual

OTHER

Lotrafilcon B contact lenses worn first, with habitual contact lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights.

Device: Lotrafilcon B contact lens; Device: Habitual contact lens

Habitual / Lotrafilcon B

OTHER

Habitual contact lenses worn first, with lotrafilcon B lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights.

Device: Lotrafilcon B contact lens; Device: Habitual contact lens

Interventions

Lotrafilcon B contact lens DEVICE

Commercially marketed, silicone hydrogel, spherical contact lens having a recommended replacement schedule of monthly.

Habitual / Lotrafilcon B; Lotrafilcon B / Habitual

Habitual contact lens DEVICE

Habitual soft spherical contact lens having a recommended replacement schedule of 2 weeks or monthly.

Habitual / Lotrafilcon B; Lotrafilcon B / Habitual

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Habitual spherical soft contact lens wearer who wears a contact lens with a recommended replacement schedule of 2 weeks or monthly.
• Wears lenses at least 5 days per week and at least 12 hours per day.
• Removes contact lenses daily or, if prescribed by their regular eye care practitioner, sleeps overnight in contact lenses no more than 6 consecutive nights.
• Reports 2 or fewer common lens-related symptoms with current contact lenses with a frequency of "frequently" or "always".
• Able to achieve distance visual acuity of at least 20/40 in each eye at the dispense of each pair of study lenses.
• Has acceptable or optimal fit for each eye at the dispense of each pair of study lenses.

You may not qualify if:

• Eye injury or surgery within twelve weeks prior to enrollment.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Currently enrolled in any clinical trial.
• Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
• Currently sleeping in contact lenses for more than 6 consecutive nights.
• Currently wearing daily disposable contact lenses and certain protocol-specified lens brands.

Sponsors & Collaborators

• CIBA VISION: lead

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Limitations and Caveats

Participants were masked to lotrafilcon B lenses only.

Results Point of Contact

• Title: Priya Janakiraman, OD, FAAO / Head, Global Clinical Affairs
• Organization: CIBA VISION

priya.janakiraman@cibavision.com

1-800-241-7629

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

Study Record Dates

• First Submitted: November 2, 2009
• First Posted: November 5, 2009
• Study Start: October 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: July 10, 2012
• Results First Posted: February 25, 2011

Record last verified: 2012-01