Dispensing Study to Assess Visual Performance of Prototype Contact Lenses

Presbyopia Clinical Trial

Official title:

Dispensing Study to Assess Visual Performance of Prototype Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02214797
• Other study ID #: CRTC2013-02
• Secondary ID: ACTRN12614000011
• Status: Completed
• Phase: N/A
• First received: August 7, 2014
• Last updated: June 23, 2015
• Start date: September 2014
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• 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 visual performance of prototype soft contact lens designs compared to commercially available contact lenses over one-week of lens wear.

Description:

Prospective, participant-masked, multiple arm, crossover dispensing clinical trial where participants will wear prototype (test) and commercial (control) lenses bilaterally. Participants will be stratified based on their refractive error into either presbyopic or non-presbyopic group. Each of the stratified group will have a maximum of 4 parallel arms. Up to 4 test lens designs will be assessed against the control/s in each parallel arm in a randomized cross over fashion, with a minimum 2 day washout period between the lens types. Each lens assessment will require 2 scheduled clinic attendances - a fitting visit and an evaluation visit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

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 18 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 in each eye with contact lenses

• Be willing to not wear contact lenses for a minimum of 2 days before each stage of the clinical trial (after informed consent)

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 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

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

• Previous corneal refractive surgery

• Contraindications to contact lens wear

• Known allergy or intolerance to ingredients in any of the clinical trial products

The Investigator may, at his/her discretion, exclude anyone who they believe may not be able to fulfil the clinical trial requirements or it is believed to be in the participant's best interests

Study Design

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

Related Conditions & MeSH terms

• Presbyopia
• Refractive Error
• Refractive Errors

Intervention

Device:
• Etafilcon A, Lotrafilcon B , Senofilcon A

Locations

Country	Name	City	State
Australia	Brien Holden Vision Institue, 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 (2)

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

Young G, Veys J, Pritchard N, Coleman S. A multi-centre study of lapsed contact lens wearers. Ophthalmic Physiol Opt. 2002 Nov;22(6):516-27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in visual performance over 1-week lens wear	Visual Acuity Visual acuity will be recorded on an interval scale. Data will be summarised as means ± standard deviations. No transformation is likely to be required. Visual acuity will be compared between test and control lens types and time across 1 week. Interactions will be tested and, if present, the significance of lens types will be determined at each time point and over time for each lens type. Visual acuity will be analysed using linear mixed model with subject random intercepts and / or paired t-test.	after about 20 minutes of lens wear and after about 1 week of lens wear	No
Secondary	Change in subjective response over 1-week of lens wear	Subjective ratings Questionnaire Subjective ratings will be recorded on a scale of 1 to 10 on steps of 1. Data will be summarised as means ± standard deviations. No transformation is likely to be required. Subjective ratings will be compared between test and control lens types and time across 1 week. Interactions will be tested and, if present, the significance of lens type will be determined at each time point and over time for each lens type. Subjective ratings will be analysed using linear mixed model with subject random intercepts and / or paired t-test.	After about 40 mins of lens wear and after 2 days, 4 days and 1 week of lens wear	No