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Clinical Performance of All-in-One Light Multi-purpose for Silicone Hydrogel Contact Lenses

NCT01392937 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 257

Last updated 2011-07-13

No results posted yet for this study

Summary

A clinical trial was conducted to assess the safety and acceptability of the Sauflon Multipurpose Solution when used with four different silicone hydrogel contact lens brands and one conventional hydrogel control lens was conducted over a period of two months, with a control group using Ciba Vision Aquify Multi- Purpose Solution. The study was conducted at six investigator sites and a total of 257 subjects were enrolled. The results of this study showed the safety, acceptability and substantial equivalence of the Sauflon Multipurpose Solution to the predicate device for its intended use.

Conditions

  • Healthy

Interventions

DEVICE

All-in-One Light multipurpose

The study was conducted over two months of wear. Subjects were examined initially, and at three follow-up visits after two weeks, one month and two months.

DEVICE

Aquify care

The study was conducted over two months of wear. Subjects were examined initially, and at three follow-up visits after two weeks, one month and two months.

Sponsors & Collaborators

  • Sauflon Pharmaceuticals Ltd

    lead INDUSTRY

Principal Investigators

  • Philip Morgan, PhD · MCOptom FAAO FBCLA

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
67 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-04-30
Completion
2011-03-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01392937 on ClinicalTrials.gov