Clinical Comparison of Two Silicone Hydrogel Toric Lenses in the US

NCT01007812 | Completed Results

• 1 other identifier: P-242-C-032
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this trial is to compare the performance of two different contact lenses for contact lens wearers with astigmatism.

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (1)

• Overall Vision

  Overall vision, as interpreted by the subject and reported by the subject on a questionnaire as a single, retrospective evaluation of one week's wear time. Overall vision was measured on a 10-point scale, with 1 being poor and 10 being excellent.

  After 1 week of wear

Study Arms (2)

Lotrafilcon B / Comfilcon A

OTHER

Lotrafilcon B silicone hydrogel, toric, soft contact lenses worn for one week, followed by Comfilcon A silicone hydrogel, toric, soft contact lenses worn for one week.

Device: Lotrafilcon B contact lens; Device: Comfilcon A contact lens

Comfilcon A / Lotrafilcon B

OTHER

Comfilcon A silicone hydrogel, toric, soft contact lenses worn for one week, followed by Lotrafilcon B silicone hydrogel, toric, soft contact lenses worn for one week.

Device: Lotrafilcon B contact lens; Device: Comfilcon A contact lens

Interventions

Lotrafilcon B contact lens DEVICE

Silicone hydrogel, toric, soft contact lens

Comfilcon A / Lotrafilcon B; Lotrafilcon B / Comfilcon A

Comfilcon A contact lens DEVICE

Silicone hydrogel, toric, soft contact lens

Comfilcon A / Lotrafilcon B; Lotrafilcon B / Comfilcon A

Eligibility Criteria

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

You may qualify if:

• Have a current spectacle prescription, preferably within 6-9 months.
• Currently wearing toric soft contact lenses in both eyes with at least 1 month experience wearing current brand for daily wear.
• Be correctable to at least 20/40 distance visual acuity in each eye while wearing trial lenses in the parameters available for this trial.
• Have 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 immediately prior to enrollment for this trial.
• Currently enrolled in any Clinical Trial.
• Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of their accessory solutions as determined by the investigator.
• Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
• Currently wearing soft toric contact lenses as extended wear.
• Currently wearing either of the products to be worn in the study.

Sponsors & Collaborators

• CIBA VISION: lead

MeSH Terms

Conditions

Astigmatism

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: 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 4, 2009
• Study Start: October 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: June 29, 2012
• Results First Posted: November 17, 2010

Record last verified: 2012-01