A trial to assess the visual performance of myopia management contact lenses in adults

Not Applicable

Completed

• Conditions: Myopia; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12623000781640
• Lead Sponsor: nthalmic Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-18
• Study Completion: 2024-06-07
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
Be aged at least 18 years and less than 40 years, male or female.
Willing to comply with the clinical trial 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.
Have experience with wearing contact lenses.
Have myopia greater than 0.75 D and no more than 6.00 D.
Have best-corrected visual acuity at least 6/7.5 (0.1 logMAR)
; Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
Be aged at least 18 years and less than 40 years, male or female.
Willing to comply with the clinical trial 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.
Have experience with wearing contact lenses.
Have myopia greater than 0.75 D and no more than 6.00 D.
Have best-corrected visual acuity at least 6/7.5 (0.1 logMAR)

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.
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 while wearing study lenses.
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.
Currently enrolled in another clinical trial.
Pregnancy at time of enrolment – verbal report sufficient.
; 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.
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 while wearing study lenses.
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.
Currently enrolled in another clinical trial.
Pregnancy at time of enrolment – verbal report sufficient.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in subjective visual performance between test and control contact lenses. Participants will rate their subjective visual performance using a non-validated 1-10 numeric rating scale in 1-point steps.<br>[ At Visit 2 (approximately 1 weeks post-enrolment)<br>At Visit 3 (approximately 2 weeks post-enrolment)<br>At Visit 4 (approximately 3 weeks post-enrolment)];Difference in subjective visual performance between test and control contact lenses. Participants will rate their subjective visual performance using a non-validated 1-10 numeric rating scale in 1-point steps.<br>[ At Visit 2 (approximately 1 weeks post-enrolment)<br>At Visit 3 (approximately 2 weeks post-enrolment)<br>At Visit 4 (approximately 3 weeks post-enrolment)]