Evaluating the Efficacy of the Combination of Multi-zonal Contact Lens and Atropine for Controlling Myopia Progression

Singapore National Eye Centre

Status and phase: Not yet enrolling; Phase 2

Conditions: Myopia

Treatments: Drug: Atropine 0.025%; Drug: Placebo; Device: Single vision Contact lens; Device: Multizonal contact lens

Study type: Interventional

Funder types: Other

Identifiers

NCT06765603

R1867/109/2021

Details and patient eligibility

About

The aim of the study is to explore efficacy of combination Atropine and multifocal CL. Randomized Control Trial including 4 arms: Atropine / multizonal CL; Atropine/ SV CL, Placebo drop/ multizonal CL; Placebo drop/ SV CL. Followed over 1 year with outcome measure of change in spherical equivalent and axial length.

Full description

see above

Enrollment: 180 estimated patients

Sex: All

Ages: 7 to 13 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Between 7 and 12 (inclusive) years of age at the time of screening.
• spherical equivalent of cycloplegic objective refraction (by autorefraction) range of -0.75 D to -4.50 D (inclusive) in each eye.
• Refractive cylinder less than 1.12 D (inclusive)
• Best-corrected visual acuity (BCVA) of 0.04 logMAR or better in each eye, with difference less than 0.20 logMAR between eyes.
• Have normal eyes (i.e., no ocular medications or infections of any type).

Exclusion criteria

• Past or current use of myopia control treatment or involvement in previous myopia control study
• Any current or seasonal use of ocular medication (eg. for allergy or chronic blepharitis).
• hypersensitivity or allergic reaction to atropine, cyclopentolate, topical anesthetics or study approved rewetting drop solutions available in local markets.
• previous history or signs of a contact lens-related corneal inflammatory event (e.g., past ulcer or scar) that may contraindicate contact lens wear.
• Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, ocular hypertension, glaucoma, history of recurrent corneal erosions, aphakia, uveitis, severe keratoconjunctivitis sicca, keratoconus, keratoconus suspect, and pellucid marginal degeneration.
• Grade 3 or greater palpebral conjunctival observations or any other Grade 2 or greater slit-lamp findings (eg. edema, corneal neovascularization, corneal staining, conjunctival injection) on the ISO 11980 classification scale.
• Any central corneal scar or corneal distortion resulting from ocular diseases or previous hard or rigid permeable contact lens wear.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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180 participants in 4 patient groups, including a placebo group

Atropine - SVCL

Experimental group

Description:

Atropine 0.025%

Treatment:

Device: Single vision Contact lens

Drug: Atropine 0.025%

Atropine- multizonal CL

Active Comparator group

Description:

Atropine 0.025% and multizonal CL

Treatment:

Device: Multizonal contact lens

Drug: Atropine 0.025%

Multizonal CL - placebo drop

Active Comparator group

Description:

Multizonal CL

Treatment:

Device: Multizonal contact lens

Drug: Placebo

Placebo drop and SVCL

Placebo Comparator group

Description:

Placebo

Treatment:

Device: Single vision Contact lens

Drug: Placebo