N/A Completed N=117 Treatment

Prospective Study of Lens Performance of a Monthly Replacement Lens at Two Weeks and Four Weeks

Myopia · Astigmatism · Presbyopia

Source: ClinicalTrials.gov NCT01293240 ↗

Enrolled (actual)

117

Serious AEs

0.0%

Results posted

Jun 2012

Primary outcomePrimary: Overall Comfort — 8.6 Units on a scale

Summary

The purpose of this study is to compare the overall performance of a monthly replacement contact lens when worn for one month and when worn for two weeks.

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Comfort	8.1	—
PRIMARY End of Day Dryness	7.0	—
PRIMARY Ocular Redness	9.0	—
PRIMARY Visual Clarity	8.2	—
PRIMARY Lens Deposits	0.8	—
PRIMARY Corrected Visual Acuity	0.04	—

Eligibility Criteria

Inclusion Criteria

Habitual and successful wearers of contact lenses made of lotrafilcon B material for at least 4 weeks prior to enrollment.
Good general health.
Sphere requirement in the range +6.00 to -10.00 with astigmatism or multifocal correction or no astigmatism or multifocal correction.
Ability to comply with all protocol-mandated procedures and to attend all scheduled office visits.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

Anterior segment abnormalities (i.e., cataracts, opacities, etc.) or active anterior segment disease.
Administration of any investigational drug or device within 14 days of study initiation.
Use of any eye drops with a pharmacological effect within 7 days of Visit 1.
Known local or systemic hypersensitivity to contact lens cleaning and disinfecting solutions.
Post-refractive surgery.
Currently pregnant or lactating by case history.
Other protocol-defined exclusion criteria may apply.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01293240). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.