Evaluation of Lotrafilcon A Lenses Over a Three Month Period

NCT00931307 | Completed Results

• 1 other identifier: P-335-C-013
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this trial is to assess the performance of a Lotrafilcon A contact lens over a 3-month period.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• Comfort After Insertion

  Comfort after insertion of contact lens (30 seconds to 1 minute), as interpreted by the subject and reported by the subject as a single, retrospective evaluation of 3-month's wear time. Comfort after insertion was measured on a 10-point scale, with 1 being poor and 10 being excellent.

  3 months

Study Arms (1)

Lotrafilcon A

EXPERIMENTAL

Device: Lotrafilcon A contact lens

Interventions

Lotrafilcon A contact lens DEVICE

Silicone hydrogel, spherical, soft contact lens

Lotrafilcon A

Eligibility Criteria

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

You may qualify if:

• On examination, have ocular findings considered to be "normal" and which would not prevent a subject from safely wearing contact lenses.
• Be willing and able to follow instructions and meet the schedule of follow-up visits as defined in the informed consent.
• Be able to wear the study lenses in the available powers.
• Currently wear contact lenses for a minimum of 5 days a week, and at least 8 hours a day.

You may not qualify if:

• Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Currently enrolled in an ophthalmic clinical trial.
• Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
• Any use of medications for which contact lens wear would be contraindicated, in the opinion of the investigator.
• History of corneal refractive surgery.

Sponsors & Collaborators

• CIBA VISION: lead

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Limitations and Caveats

Due to the small number of subjects successfully completing this trial, the results should be interpreted with caution.

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: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2009
• First Posted: July 2, 2009
• Study Start: May 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: June 29, 2012
• Results First Posted: October 6, 2010

Record last verified: 2010-10