N/A Completed N=74 Randomized Double-blind Treatment

Multi-Centre Clinical Evaluation of Two Reusable Soft Contact Lenses

Myopia

Source: ClinicalTrials.gov NCT02815735 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2017

Primary outcomePrimary: Comfort — 8.90; 9.03; 8.70; 8.74 units on a scale

Summary

The aim of this study is to compare the subjective performance of the comfilcon A contact lens against lotrafilcon B contact lens after 4 weeks of reusable lens wear.

Outcome Measures

Outcome	Result	p-value
PRIMARY Comfort	8.90; 9.03; 8.70; 8.74; 8.60; 8.86	—
PRIMARY Comfort During the Day	8.98; 8.78; 8.67; 8.96; 8.78; 8.59	—

Eligibility Criteria

Inclusion Criteria

Spherical distance CL (Contact Lens) prescription between -1.00 and -6.00D (Diopter) OR in both eyes (inclusive)
Adapted soft CL wearers (i.e. >1 month) who are reusable lens wearers*
Spectacle cylinder 0.75D in both eyes
Correctable to 6/9 in both eyes
Be between 18 and 34 years of age (inclusive)
Able to read, comprehend and sign an informed consent
Own a mobile phone and be able to respond to SMS survey during the period 8am - 8pm
Willing to comply with the wear and study visit schedule

Exclusion Criteria

Any of the following will render a subject ineligible for inclusion:

Existing wearer of daily disposable contact lenses
Known allergy to Opti-Free PureMoist multipurpose solution
Any active corneal infection, injury or inflammation
Systemic or ocular allergies, which might interfere with CL wear
Systemic disease, which might interfere with CL wear
Ocular disease, which might interfere with CL wear
Strabismus or amblyopia
Subjects who have undergone corneal refractive surgery
Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear
Pregnant, planning a pregnancy or lactating
Use of systemic/topical medication contraindicating CL wear
Diabetic
Site employees or family members of investigators
Participation in any concurrent trial or in the last 30 days

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02815735). 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.