N/A Completed N=66 Randomized Single-blind

A Study to Evaluate a New Silicone Hydrogel Contact Lens

Myopia

Source: ClinicalTrials.gov NCT01309893 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2014

Primary outcomePrimary: Distance High Contrast logMAR Visual Acuity at 1 Week — -0.031; -0.015 logMAR

Summary

The objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lenses.

Outcome Measures

Outcome	Result	p-value
PRIMARY Distance High Contrast logMAR Visual Acuity at 1 Week	-0.031; -0.015	—
SECONDARY Slit Lamp Findings ≥ Grade 2	0; 0	—
SECONDARY Overall Comfort	57.3; 80.8	—

Eligibility Criteria

Inclusion Criteria

Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
Be myopic and require lens correction from -0.50 D to -5.50 D in each eye.

Exclusion Criteria

Any systemic disease affecting ocular health.
Using any systemic or topical medications that will affect ocular physiology or lens performance.
An active ocular disease, any corneal infiltrative response or are using any ocular medications.
Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
Allergic to any component in the study care products.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01309893). 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.