Study to assess the visual performance of prototype contact lenses.

Prospective, participant-masked, bilateral wear, crossover clinical trial to assess visual performance of multiple prototype contact lens designs compared to commercial contact lenses in presbyopes.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613001380785

Enrollment

119

Registered

2013-12-16

Start date

2013-11-22

Completion date

2014-07-23

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

To assess the visual performance of multiple prototype soft contact lens designs.

Interventions

The contact lenses being studied are prototype soft contact lenses made from Etafilcon A material. The lenses differ only in their power profile - all are made from the same material. Participants will test up to 25 pairs of lenses with a minimum overnight wash-out period between each pair. Ideally, all participants would test all 25 pairs, however as they are able to withdraw at any time, the number of lenses tested is essentially determined by the participant. Lenses will be inserted bilate

Study design

Allocation

Non-randomised trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject)

Eligibility

Sex/Gender

All

Age

40 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent. Be at least 40 years old, with presbyopia (reading add of 1 Dioptre or more). 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 experienced or inexperienced at wearing 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 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.

Outcome results