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

This study has been completed.
Sponsor:
Information provided by:
Sauflon Pharmaceuticals Ltd
ClinicalTrials.gov Identifier:
NCT01392937
First received: July 6, 2011
Last updated: July 11, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Healthy
Device: All-in-One Light multipurpose
Device: Aquify care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: The Clinical Performance of the All-in-One Light Multi-purpose Care Regimen for Silicone Hydrogel Contact Lenses

Resource links provided by NLM:


Further study details as provided by Sauflon Pharmaceuticals Ltd:

Primary Outcome Measures:
  • Overall subjective acceptance. [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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).


Enrollment: 257
Study Start Date: March 2010
Study Completion Date: March 2011
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: All-in-One Light multipurpose
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
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.
Active Comparator: Aquify care
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
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.

Detailed Description:

1.1 Study characteristics This study evaluated 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).

The key study features were as follows:

  1. Two months duration.
  2. Six investigator sites.
  3. Daily wear soft (hydrophilic) contact lenses, replaced on a two-weekly basis: Air Optix Aqua, PureVision, Biofinity, Acuvue Advance and Acuvue 2; with one of two care regimens: All-in-One Light and Aquify.
  4. A total of 257 subjects were enrolled, and 256 subjects accounting for 512 eyes were dispensed lenses. This group was randomized into 173 test subjects (346 eyes) and 83 control subjects (166 eyes).
  5. Of the 173 test subjects, 163 (94.2%) completed two months of use. Of the 83 control subjects, 73 (88.0%) completed two months of use.
  6. No eyes remained active at the end of the study.
  7. There were no adverse reactions. 1.2 Study period 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. Study visits commenced on March 29, 2010 and were completed on March 11, 2011.

1.3 Demographics Six investigator sites dispensed 173 test subjects (346 eyes) who used All-in-One Light as their care regimen during the work. Also dispensed were 83 control subjects (166 eyes)who used Aquify as their care regimen during the work. All recruited subjects were existing contact lenses wearers.

Of the 173 test subjects, 163 (94.2%) completed two months of use and ten (5.8%) were discontinued. Of the 83 control subjects, 73 (88.0%) completed two months of use and ten (12.2%) were discontinued.

The enrolled control group was made up of 51 females (61%) and 32 males (39%) with an age range from 18 to 67 years (mean 36.7 years). The enrolled test group was composed of 117 females (67%) and 57 males (33%) with an age range from 18 to 65 years (mean 34.1 years). One subject (female, age 45 years) was enrolled and assigned to the test group but was not dispensed lenses.

  Eligibility

Ages Eligible for Study:   18 Years to 67 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects will only be eligible for the study if:

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

Exclusion Criteria:

  • Subjects will not be eligible if:

    1. They have an ocular disorder which would normally contra-indicate contact lens wear.
    2. They have a systemic disorder which would normally contra-indicate contact lens wear.
    3. They are using any topical medication such as eye drops or ointment.
    4. They are aphakic.
    5. They have had corneal refractive surgery.
    6. They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
    7. They are pregnant or lactating.
    8. 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.
    9. They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392937

Locations
United Kingdom
Eurolens Research Faculty of Life Sciences The University of Manchester
Manchester, United Kingdom
Sponsors and Collaborators
Sauflon Pharmaceuticals Ltd
Investigators
Principal Investigator: Philip Morgan, PhD MCOptom FAAO FBCLA
  More Information

No publications provided

Responsible Party: Howard Griffiths, Sauflon Pharmaceuticals Limited
ClinicalTrials.gov Identifier: NCT01392937     History of Changes
Other Study ID Numbers: S09-469
Study First Received: July 6, 2011
Last Updated: July 11, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Sauflon Pharmaceuticals Ltd:
AIOL
multipurpose solution
silicone hydrogel lenses
The safety and efficacy of the All-in-One Light multipurpose care regimen by comparison with the Aquify care regimen

ClinicalTrials.gov processed this record on August 18, 2014