Dispensing Study to Assess the Visual Performance of Optimised Prototype Contact Lenses

Presbyopia Clinical Trial

Official title:

Dispensing Study to Assess the Visual Performance of Optimised Prototype Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02484586
• Other study ID #: CRTC2014-04
• Status: Completed
• Phase: N/A
• First received: June 24, 2015
• Last updated: September 8, 2017
• Start date: October 2015
• Est. completion date: February 7, 2017

Study information

• Verified date: September 2017
• Source: Brien Holden Vision
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to assess the visual performance of multiple optimised prototype soft contact lens designs compared to commercially available contact lenses.

Description:

Prospective, double-masked, crossover, bilateral wear, dispensing clinical trial where participants will wear multiple prototype (test) and commercial (control) lenses.

Multiple prototype contact lens designs will be assessed against commercial control lenses during the study, where each design will be worn for up to a week. There will be a minimum 1 night washout period between lens designs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: February 7, 2017
• Est. primary completion date: February 7, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• 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.

• Is correctable to at least 6/12 (20/40) or better in each eye 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, Sjogrens 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. Ocular medication can be prescribed during the course of the trial as per standard optometric practice.

• 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. Note: 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.

Related Conditions & MeSH terms

• Presbyopia
• Refractive Error
• Refractive Errors

Intervention

Device:
• Etafilcon A
Prototype lens material
• Etafilcon A
Control lens for presbyope group
• Nelfilcon A
Control lens for presbyope group
• Nesofilcon A
Control lens for presbyope group
• Nelfilcon A
Control lens for non-presbyope group
• Etafilcon A
Control lens for non-presbyope group
• Somofilcon A
Control lens for presbyope group
• 58% Poly-HEMA
Control lens for presbyope group
• Omafilcon A
Control lens for non-presbyope group

Locations

Country	Name	City	State
Australia	Brien Holden Vision Institute	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Brien Holden Vision

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity on a LogMAR (logarithm of the minimum angle of resolution) scale	For each lens, visual acuity will be measured at distance with a computerised LogMAR chart and at near with a near LogMAR chart. Data will be summarised as means +/- standard deviations. No transformation is likely to be required. Visual acuity will be compared between each lens design and control lens types. The significance of lens design will be determined for each visit.; Repeated effects linear mixed model with subject random intercepts or paired t tests will be employed for the analysis of visual acuity. Analysis will be performed within each study arm namely presbyopes and non-presbyopes.	Approximately 1 week after lens fitting
Secondary	Subjective rating of vision on a 1-10 visual analogue scale	For each lens, subjective ratings of vision will be assessed with a questionnaire based on a 1 to 10 scale in steps of 1. The questionnaire has been designed specifically for this study. Data will be summarised as means +/- standard deviations. No transformation is likely to be required. Subjective ratings will be compared between each lens design and control lens types. The significance of lens design will be determined for each visit. Repeated effects linear mixed model with subject random intercepts or paired t tests will be employed for the analysis of subjective ratings. Analysis will be performed within each study arm namely presbyopes and non-presbyopes.	Approximately 1 week after lens fitting