NCT01996787

Brief Summary

The purpose of this study was to investigate the safety and efficacy of the Sauflon Clariti Monthly silicone hydrogel contact lenses with handling tint (Sauflon Pharmaceuticals Limited) by comparison with Air Optix Aqua silicone hydrogel lenses (Alcon Inc.) Subjects used OptiFree Replenish solution (Alcon Lboratories Inc.) for daily lens maintenance, care and storage.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2013

Shorter than P25 for not_applicable

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

June 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 27, 2013

Completed
Last Updated

November 27, 2013

Status Verified

November 1, 2013

Enrollment Period

1 month

First QC Date

November 7, 2013

Last Update Submit

November 26, 2013

Conditions

HyperopiaMyopia

Keywords

visibility tinted silicone hydrogel contact lenses for daily wear

Outcome Measures

Primary Outcomes (4)

  • Slit lamp Biomicroscopy

    Slit Lamp examination will be performed at the initial and follow-up visits. Slit lamp findings will be graded on a 0-4 scale (0=none;4=severe).

    1 month

  • Adverse reactions

    Adverse reactions will be recorded throughout the study. Adverse recations will be classified as serious, significant and non-significant.

    1 month

  • Wear Time

    Lens wear time is recorded for the two study lenses at follow-up visits.

    1 month

  • Visual Acuity

    LogMAR Visual Acuity at high contrast will be recorded before and after performeing an over-refraction at the initial, two-week and one-month visits.

    1 month

Secondary Outcomes (5)

  • Subjective Scores

    1 month

  • Symptoms, problems and complaints

    1 month

  • Discontinuations

    1 month

  • Refraction

    1 month

  • Keratometry

    1 month

Study Arms (2)

Air Optix Aqua

ACTIVE COMPARATOR

Compare safety and efficacy of the lens using OptiFree Replenish solution

Device: Air Optix AquaDevice: Clariti with Handling Tint

Clariti with Handling Tint

ACTIVE COMPARATOR

Compare safety and efficacy of the lens using OptiFree Replenish solution

Device: Air Optix AquaDevice: Clariti with Handling Tint

Interventions

Air Optix AquaDEVICE

Lenses will be worn on a daily wear basis (i.e. removed at night and stored in solution) and worn in the normal way. Lenses will be worn for one month. Lenses should be worn for a minimum of six hours a day, four days a week. The lenses are also to be worn for a minimum of two hours before attending all follow-up visits.

Air Optix AquaClariti with Handling Tint
Clariti with Handling TintDEVICE

Lenses will be worn on a daily wear basis (i.e. removed at night and stored in solution) and worn in the normal way. Lenses will be worn for one month. Lenses should be worn for a minimum of six hours a day, four days a week. The lenses are also to be worn for a minimum of two hours before attending all follow-up visits.

Air Optix AquaClariti with Handling Tint

Eligibility Criteria

Age19 Years - 56 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify 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
  • The agree not to paticipate in other clinical research for the duration of this study
  • They have a best spectacle corrected visual acuity greater or equal to 20/25 (logMAR 0.1)
  • They have a manifest cylinder less than or equal to 0.75D
  • 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 range available
  • They are willing to wear the study lenses for a minimum of four days a week, six hours a day

You may not qualify if:

  • They have any active anterior segment ocular disease which would normally contraindicate contact lens wear
  • They have any anterior segment infection, inflammation or abnormality
  • They use any systemic medications which would normally contraindicate contact lens wear
  • They are using any ocular medications
  • They have a history of herpetic keratitis
  • They have a systemic disorder which would normally contraindicate contact lens wear
  • They have any infectious disease (e.g. Hepatitis) or any immunosuppressive disease (e.g. HIV)
  • They have glaucoma (high pressure in the eye), have had cataract surgery or a history of recurring abrasions
  • They have had corneal refractive surgery or they have an irregular cornea
  • They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus
  • They are pregnant or lactating
  • They have any slit lamp findings which are more serious than grade 1
  • They have a history of anaphylaxis or severe allergic reactions
  • They have taken part in any other contact lens or contact lens care product 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, M60 1QD, United Kingdom

Location

Related Publications (3)

  • Varikooty J, Keir N, Richter D, Jones LW, Woods C, Fonn D. Comfort response of three silicone hydrogel daily disposable contact lenses. Optom Vis Sci. 2013 Sep;90(9):945-53. doi: 10.1097/OPX.0b013e31829d8dbf.

    PMID: 23892493RESULT

  • Belda-Salmeron L, Ferrer-Blasco T, Albarran-Diego C, Madrid-Costa D, Montes-Mico R. Diurnal variations in visual performance for disposable contact lenses. Optom Vis Sci. 2013 Jul;90(7):682-90. doi: 10.1097/OPX.0b013e318299088f.

    PMID: 23770656RESULT

  • Montes-Mico R, Belda-Salmeron L, Ferrer-Blasco T, Albarran-Diego C, Garcia-Lazaro S. On-eye optical quality of daily disposable contact lenses for different wearing times. Ophthalmic Physiol Opt. 2013 Sep;33(5):581-91. doi: 10.1111/opo.12044. Epub 2013 Mar 19.

    PMID: 23510388RESULT

Related Links

MeSH Terms

Conditions

HyperopiaMyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Philip Morgan, PhD

    MCOptom FAAO FBCLA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2013

First Posted

November 27, 2013

Study Start

June 1, 2013

Primary Completion

July 1, 2013

Study Completion

September 1, 2013

Last Updated

November 27, 2013

Record last verified: 2013-11

Locations

GB(1)