A clinical trial where 120 participants will wear one of three contact lenses (SEED Pure, CooperVision Proclear or Johnson & Johnson Vita), for three months with monthly replacement to determine clinical performance.

Category Primary study
Registry of TrialsANZCTR
Year 2018
INTERVENTION: This trial will be a prospective, bilateral, randomised, open‐label clinical trial. Participants will wear one of three lens types for three months with monthly replacement daily wear basis in conjunction with OPTI‐FREE Puremoist multipurpose disinfecting solution. The three lens types comprise: Commercially‐available (Europe and Japan) single vision lenses manufactured by SEED and made from SEED ionic bond (SIB) material: Base curve: 8.6 mm, Diameter: 14.2 mm, Power Range: ‐0.75 to ‐6.00 D. Commercially‐available (Australia) lenses single vision lenses manufactured by Johnson & Johnson and made from senofilcon C material: Base curve: 8.4 mm, Diameter: 14 mm, Power Range: ‐0.75 to ‐6.00 D. Commercially‐available (Australia) lenses single vision lenses manufactured by CooperVision and made from omafilcon A material: Base curve: 8.6 mm, Diameter: 14 mm, Power Range: ‐0.75 to ‐6.00 D. At each visit, investigators will ensure that participants have one pair of lenses to wear and one spare pair of lenses. Minimum wearing time will be 5 days per week and 6 hours per day when lenses are worn with no maximum wearing time provided lenses are not slept in overnight. There will 5 visits comprising Baseline and four follow‐up visits at 2‐weeks, 1‐month, 2‐months, 3‐months after Baseline. Each visit will be approximately 45 minutes in duration. Baseline visits will comprise auto‐refraction, subjective refraction with visual acuity measurement, ocular assessment with a slit‐lamp biomicroscope (a specialized microscope for viewing the eye, lens fitting, lens assessment with slit‐lamp biomicroscope and questionnaire (see below). All assessment visits will comprise questionnaires (see below), visual acuity measurement and lens and ocular assessment with slit‐lamp biomicroscope. Questionnaires will be completed at all visits, and will utilise numeric rating scales (1‐10 in 1‐point steps) and 6‐point Likert scales. All contact lenses will be prescribed and all assessments will be carried out by an optometrist. Participants will be instructed to return all unused contact lenses not commercially‐available in Australia. CONDITION: Myopia PRIMARY OUTCOME: Subjective rating of clarity of vision with contact lenses as assessed with a questionnaire utilising numeric rating scales (1‐10 in 1‐point steps) . Subjective rating of comfort with contact lenses as assessed with a questionnaire utilising numeric rating scales (1‐10 in 1‐point steps) . Subjective rating of lens handling with contact lenses as assessed with a questionnaire utilising numeric rating scales (1‐10 in 1‐point steps). 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 6/7.5 (20/25) or better in each eye with best‐corrected subjective refraction and 6/12 (20/40) or better in each eye with contact lenses. Can be an experienced or first time (neophyte) contact lens wearer. Be able to insert and remove contact lenses. SECONDARY OUTCOME: Lens deposition as assessed with a slit‐lamp biomicroscope and graded on a 0‐4 scale. Lens wettability as assessed with a slit‐lamp biomicroscope and graded on a 0‐4 scale. Ocular fluorescein staining as assessed with a slit‐lamp biomicroscope and graded on a 0‐4 scale. Ocular redness as assessed with a slit‐lamp biomicroscope and graded on a 0‐4 scale. Ocular roughnesss as assessed with a slit‐lamp biomicroscope and graded on a 0‐4 scale. Subjective assessment of comfort with contact lenses as assessed with a questionnaire utilising a 6‐point Likert scale. Subjective assessment of lens handling with contact lenses as assessed with a questionnaire utilising a 6‐point Likert scale. Subjective assessment of vision with contact lenses as assessed with a questionnaire utilising a 6‐point Likert scale. Visual acuity. This will be assessed at 6 m using standard logMAR charts under photopic conditions.
Epistemonikos ID: dae720d949b8af738174f27e6a287f709c010fd2
First added on: Aug 24, 2024