Dispensing Study to Assess Visual Performance of Prototype Contact Lenses

NCT02214797 | Completed

• 2 other identifiers: CRTC2013-02ACTRN12614000011684
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Presbyopia; Refractive Error

Keywords

Presbyopia; Refractive Error; Contact Lenses

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change in subjective response over 1-week of lens wear

  After about 40 mins of lens wear and after 2 days, 4 days and 1 week of lens wear

Study Arms (4)

Presbyopic group - Low Add

OTHER

40 years and over Add of less than +1.50D Control lens : Lotrafilcon B and Senofilcon A Test lens: Etafilcon A Up to 4 test lens designs will be assessed against commercial control/s in each parallel arm in a randomised cross over fashion. Each lenses will be worn for a week with a minimum 2 day washout period between the lens types. Each lens will require 2 scheduled clinic attendances - a fitting visit and an evaluation visit.

Device: Etafilcon A, Lotrafilcon B , Senofilcon A

Presbyopic group - Med Add

OTHER

40 years and over Add of +1.50D to +1.75D Control lens : Lotrafilcon B and Senofilcon A Test lens: Etafilcon A Up to 4 test lens designs will be assessed against commercial control/s in each parallel arm in a randomised 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.

Device: Etafilcon A, Lotrafilcon B , Senofilcon A

Presbyopic group - High Add

OTHER

40 years and over Add of +2.00D to +2.50D Control lens : Lotrafilcon B and Senofilcon A Test lens: Etafilcon A Up to 4 test lens designs will be assessed against commercial control/s in each parallel arm in a randomised 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.

Device: Etafilcon A, Lotrafilcon B , Senofilcon A

Non-presbyopic group

OTHER

18 to 39 years old No Add Control lens : Lotrafilcon B and Etafilcon A Test lens: Etafilcon A Up to 4 test lens designs will be assessed against commercial control/s in each parallel arm in a randomised 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.

Device: Etafilcon A, Lotrafilcon B , Senofilcon A

Interventions

Etafilcon A, Lotrafilcon B , Senofilcon A DEVICE

Also known as: Control lenses, Non-presbyopic group, Brand name: Air Optix® Aqua , Acuvue® 1-Day Moist, Lens material: Lotrafilcon B , Etafilcon A, Presbyopic group, Brand name: Air Optix® Multifocal, Acuvue® Oasys for Presbyopia, Lens material Lotrafilcon B, Senofilcon A, Test lens, Brand name: Iteration X, Lens material: Etafilcon A

Non-presbyopic group; Presbyopic group - High Add; Presbyopic group - Low Add; Presbyopic group - Med Add

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Brien Holden Vision: lead

Study Sites (1)

Brien Holden Vision Institue, Clinical Research Trials Center

Sydney, New South Wales, 2052, Australia

Location

Related Publications (3)

• 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. doi: 10.1046/j.1475-1313.2002.00066.x.

  PMID: 12477016 BACKGROUND

• 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.

  PMID: 18538404 BACKGROUND

• Jong M, Tilia D, Sha J, Diec J, Thomas V, Bakaraju RC. The Relationship between Visual Acuity, Subjective Vision, and Willingness to Purchase Simultaneous-image Contact Lenses. Optom Vis Sci. 2019 Apr;96(4):283-290. doi: 10.1097/OPX.0000000000001359.

  PMID: 30907859 DERIVED

MeSH Terms

Conditions

Presbyopia; Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Jiyoon Chung, BOptom

  Brien Holden Vision Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2014
• First Posted: August 12, 2014
• Study Start: September 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 25, 2015

Record last verified: 2015-06

Locations

AU (1)