Contact Lenses Utilising S.T.O.P.® Technology Versus Dual-focus Contact Lenses for Slowing Down Myopia Progression in Children: A Three-year Prospective, Multi-centre, Controlled, Masked, Randomised, Non Inferiority Clinical Trial

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

To compare the rate of myopia progression of contact lenses utilising S.T.O.P.® technology against MiSight® contact lenses.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 14
Healthy Volunteers: f
View:

• Be between 8-14.

• Have:

‣ Read the Informed Assent.

⁃ Been explained the Informed Assent.

⁃ Indicated an understanding of the Informed Assent.

⁃ Signed the Informed Assent.

• Have their parent / legal guardian:

‣ Read the Informed Consent.

⁃ Been explained the Informed Consent.

⁃ Indicated an understanding of the Informed Consent.

⁃ Signed the Informed Consent.

• Along with their parent / legal guardian, be capable of comprehending the nature of the study, and be willing and able to adhere to study requirements.

• Along with their parent / legal guardian, agree to maintain the visit schedule .

• Agree to wear allocated contact lenses for a minimum of 5 days per week, at least 6 hours per day on days lenses are worn but not \> 16 hours per day, and to remove lenses at night (i.e., daily wear only with no contact lens wear during sleep), for their duration of the study and to inform the investigator if their schedule is interrupted. Wearing time can be modified by the investigator for health reasons.

• Possess wearable and visually functioning spectacles.

• Be in good general health, based on the parent's / legal guardian's knowledge.

• Have best-corrected high contrast visual acuity based on manifest refraction of 0.10 logMAR (20/25, 6/7.6) or better in each eye.

• Meet the following criteria determined by cycloplegic autorefraction:

‣ Spherical equivalent between -0.75 to -4.00 D inclusive.

⁃ Astigmatism ≥ -1.00 D.

‣ \*participants who fail astigmatism criterion with autorefraction pass astigmatism criterion if ≥ -0.75 D is measured with subjective refraction.

⁃ anisometropia ≤ 1.00 D.

Locations
Other Locations
China
Shanghai Fudan University Eye and ENT Hospital
ACTIVE_NOT_RECRUITING
Shanghai
Tianjin Medical University
ACTIVE_NOT_RECRUITING
Tianjin
Wenzhou Medical University Eye Hospital
ACTIVE_NOT_RECRUITING
Wenzhou
India
LV Prasad Eye Institute
ACTIVE_NOT_RECRUITING
Hyderabad
The University of Hyderabad
NOT_YET_RECRUITING
Hyderabad
Spain
Ocupharm Research Group (Clinica Universitaria de Optometría), Universidad Complutense Madrid
ACTIVE_NOT_RECRUITING
Madrid
Lab. de Superficie Ocular y Lentes de Contacto (SOYLC)
RECRUITING
Santiago De Compostela
Centre Universitari de la Visió
RECRUITING
Terrassa
Contact Information
Primary
Daniel Tilia, MOptom, PhD
d.tilia@nthalmic.com
+61290377700
Time Frame
Start Date: 2023-08-04
Estimated Completion Date: 2028-01
Participants
Target number of participants: 441
Treatments
Active_comparator: MiSight®
MiSight® Contact Lens (Omafilcon A, 60% water)
Experimental: S.T.O.P® F2
S.T.O.P® F2 Contact Lens (Ocufilcon D, 55% water)
Experimental: S.T.O.P® DT
S.T.O.P® DT Contact Lens (Ocufilcon D, 55% water)
Related Therapeutic Areas
Sponsors
Collaborators: Brighten Optix Corporation
Leads: nthalmic Pty Ltd

This content was sourced from clinicaltrials.gov