Visual Performance of Prototype Contact Lens Designs

Presbyopia Clinical Trial

Official title:

Visual Performance of Prototype Contact Lens Designs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02193555
• Other study ID #: CRTC2014-02
• Status: Completed
• Phase: N/A
• First received: July 16, 2014
• Last updated: November 4, 2014
• Start date: July 2014
• Est. completion date: November 2014

Study information

• Verified date: July 2014
• Source: Brien Holden Vision
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to assess the visual performance of prototype soft contact lens designs compared to a commercially available contact lens

Description:

Prospective, participant-masked, randomised, stratified, crossover, bilateral wear, dispensing clinical trial where participants will wear the prototype (test) and the commercial (control) lens. A minimum of an overnight washout period is required between the fitting /assessment visits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: November 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years and older

Eligibility

Inclusion Criteria:

• Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.

• Be at least 7 years old, male or female.

• Willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator.

• Have ocular health findings considered to be "normal" and which would not prevent the participant from safely wearing contact lenses.

• Correctable to at least 6/12 (20/40) or better with both eyes with contact lenses.

• Be suitable and willing to wear contact lenses.

Exclusion Criteria:

• Any pre-existing ocular irritation, injury or condition (including infection or disease) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses.

• Any systemic disease that adversely affects ocular health e.g. diabetes, Graves' disease, and auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants.

• Use of or a need for concurrent category S3 and above ocular medication at enrolment and/or during the clinical trial.

• Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant's ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and/or during the clinical trial.

• Eye surgery within 12 weeks immediately prior to enrolment for this trial.

NB: Systemic antihistamines are allowed on an "as needed basis", provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Presbyopia
• Refractive Error
• Refractive Errors

Intervention

Device:
• Etafilcon A, Senofilcon A
1 pair of either test or control lenses will be fitted on the subject for up to 1 hour of lens wear per visit (total of 2 fitting visits).

Locations

Country	Name	City	State
Australia	Brien Holden Vision Institute, Clinical Research Trials Center	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Brien Holden Vision

Country where clinical trial is conducted

Australia, 

References & Publications (4)

Anstice NS, Phillips JR. Effect of dual-focus soft contact lens wear on axial myopia progression in children. Ophthalmology. 2011 Jun;118(6):1152-61. doi: 10.1016/j.ophtha.2010.10.035. Epub 2011 Jan 26. — View Citation

Morgan PB, Efron N. A decade of contact lens prescribing trends in the United Kingdom (1996-2005). Cont Lens Anterior Eye. 2006 May;29(2):59-68. Epub 2006 Mar 31. — View Citation

Sankaridurg P, Holden B, Smith E 3rd, Naduvilath T, Chen X, de la Jara PL, Martinez A, Kwan J, Ho A, Frick K, Ge J. Decrease in rate of myopia progression with a contact lens designed to reduce relative peripheral hyperopia: one-year results. Invest Ophthalmol Vis Sci. 2011 Dec 9;52(13):9362-7. doi: 10.1167/iovs.11-7260. — View Citation

Stapleton F, Keay L, Edwards K, Naduvilath T, Dart JK, Brian G, Holden BA. The incidence of contact lens-related microbial keratitis in Australia. Ophthalmology. 2008 Oct;115(10):1655-62. doi: 10.1016/j.ophtha.2008.04.002. Epub 2008 Jun 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual performance	Visual acuity	After about 20 minutes of lens wear	No
Secondary	Subjective responses	Subjective ratings of vision	After about 40 minutes of lens wear	No