Clinical Evaluation of a Silicone Hydrogel Lens

NCT01016132 | Completed Results

• 1 other identifier: P-019-C-055
• Study Type: interventional
• Target: 152
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess the performance of an investigational contact lens among contact lens wearers.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• Overall Preference

  Overall preference when comparing study lenses to "habitual" lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of four weeks' wear time. Overall preference was measured on a 5-point Likert scale as follows: Strongly Prefer Study Lenses; Somewhat Prefer Study Lenses; No Preference; Somewhat Prefer "Habitual" Lenses; Strongly Prefer "Habitual" Lenses.

  4 weeks of wear

Interventions

lotrafilcon A contact lens DEVICE

Investigational silicone hydrogel, single-vision, soft contact lens worn for four weeks at least as often as and on the same basis as participant's habitual lenses, as prescribed by participant's eye care practitioner -- ie., on a daily wear, flex wear, or extended wear basis.

Eligibility Criteria

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

You may qualify if:

• Currently wearing lotrafilcon A lenses in both eyes for a minimum of 5 days per week, 8 hours per day, for 3 months.
• Removes contact lenses daily or sleeps overnight in contact lenses (up to 30 consecutive nights) as prescribed by regular eye care practitioner.
• Able to achieve distance visual acuity of at least 20/40 in each eye with study lenses.

You may not qualify if:

• Eye injury or surgery within 12 months prior to enrollment.
• Currently enrolled in any clinical trial.
• History of corneal refractive surgery.

Sponsors & Collaborators

• CIBA VISION: lead

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

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: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2009
• First Posted: November 18, 2009
• Study Start: October 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 29, 2012
• Results First Posted: January 12, 2011

Record last verified: 2011-09