NCT01392937

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
257

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Mar 2010

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 13, 2011

Completed
Last Updated

July 13, 2011

Status Verified

July 1, 2011

Enrollment Period

1 month

First QC Date

July 6, 2011

Last Update Submit

July 11, 2011

Conditions

Healthy

Keywords

AIOLmultipurpose solutionsilicone hydrogel lensesThe safety and efficacy of the All-in-One Light multipurpose care regimen by comparison with the Aquify care regimen

Outcome Measures

Primary Outcomes (1)

  • Overall subjective acceptance.

    The safety and efficacy of the All-in-One Light multipurpose care regimen (Sauflon Pharmaceuticals Limited) by comparison with the Aquify care regimen(Ciba Vision Inc.). Each subject used one of five different lens brands: Air Optix Aqua(Ciba Vision Inc.), PureVision (Bausch + Lomb Inc.), Biofinity (CooperVision Inc.), Acuvue Advance and Acuvue 2 (both Johnson \& Johnson).

    2 months

Study Arms (2)

All-in-One Light multipurpose

ACTIVE COMPARATOR

Used All in One light multipurpose with one of five different lens brands: Air Optix Aqua(Ciba Vision Inc.), PureVision (Bausch + Lomb Inc.), Biofinity (CooperVision Inc.), Acuvue Advance and Acuvue 2 (both Johnson \& Johnson).

Device: All-in-One Light multipurpose

Aquify care

ACTIVE COMPARATOR

Use Aquify care with one of five different lens brands: Air Optix Aqua(Ciba Vision Inc.), PureVision (Bausch + Lomb Inc.), Biofinity (CooperVision Inc.), Acuvue Advance and Acuvue 2 (both Johnson \& Johnson).

Device: Aquify care

Interventions

All-in-One Light multipurposeDEVICE

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.

All-in-One Light multipurpose
Aquify careDEVICE

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.

Aquify care

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects will only be eligible for the study if:
  • They are 18 years of age and above.
  • They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
  • They are willing and able to follow the protocol.
  • They agree not to participate in other clinical research for the duration of this study.
  • They can attain at least 6/12 in each eye with the study contact lenses.
  • They have successfully worn contact lenses within six months of starting the study.
  • They can be fitted with spherical soft contact lenses within the power ranges of the study lenses.

You may not qualify if:

  • Subjects will not be eligible if:
  • They have an ocular disorder which would normally contra-indicate contact lens wear.
  • They have a systemic disorder which would normally contra-indicate contact lens wear.
  • They are using any topical medication such as eye drops or ointment.
  • They are aphakic.
  • They have had corneal refractive surgery.
  • They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
  • They are pregnant or lactating.
  • They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
  • They have taken part in any other clinical trial or research, within two weeks prior to starting this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eurolens Research Faculty of Life Sciences The University of Manchester

Manchester, Manchester, United Kingdom

Location

Study Officials

  • Philip Morgan, PhD

    MCOptom FAAO FBCLA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 6, 2011

First Posted

July 13, 2011

Study Start

March 1, 2010

Primary Completion

April 1, 2010

Study Completion

March 1, 2011

Last Updated

July 13, 2011

Record last verified: 2011-07

Locations

GB(1)