NCT01787760

Controlling Myopia Progression With Soft Contact Lenses

Completed NA Results posted Last updated 19 June 2018

What this trial tests

NA trial testing Test Soft Contact Lens B in Myopia in 221 participants. Completed in 1 April 2010.

Timeline

1 April 2007

Primary endpoint
1 April 2010

1 April 2010

Quick facts

Lead sponsor	Johnson & Johnson Vision Care, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	221
Start date	1 April 2007
Primary completion	1 April 2010
Estimated completion	1 April 2010
Sites	1 location across Hong Kong

Drugs / interventions tested

• Test Soft Contact Lens B
• Test Soft Contact Lens C
• Active Comparator — full drug profile →

Conditions studied

• Myopia — all drugs for Myopia →

Sponsor

Johnson & Johnson Vision Care, Inc. — full company profile →

Who can join

Adults 8 to 12, any sex, with Myopia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Axial Length (Axial Elongation) Primary · Baseline and every 6 months post-baseline up to 3 years

Axial Length was measured with the IOLMaster at baseline, and then every 6 months throughout the course of the study. Five measurements were collected for each eye at each visit and the average of the 5 measurements were used for the analysis. Higher values of axial elongation indicate worse vision.

Change from baseline 6 months

Group	Value	95% CI
Spectacle Lenses	0.158	± 0.0981
Test Soft Contact Lens B	0.144	± 0.0834
Test Soft Contact Lens C	0.121	± 0.0749

Change from baseline 12 months

Group	Value	95% CI
Spectacle Lenses	0.242	± 0.1448
Test Soft Contact Lens B	0.236	± 0.1267
Test Soft Contact Lens C	0.222	± 0.1288

Change from baseline 18 months; N=92, N=54, N=72

Group	Value	95% CI
Spectacle Lenses	0.348	± 0.2129
Test Soft Contact Lens B	0.355	± 0.1837
Test Soft Contact Lens C	0.344	± 0.1676

Change from baseline 24 months; N=92, N=54, N=72

Group	Value	95% CI
Spectacle Lenses	0.455	± 0.2520
Test Soft Contact Lens B	0.409	± 0.2247
Test Soft Contact Lens C	0.445	± 0.2444

Change from baseline 30 months

Group	Value	95% CI
Spectacle Lenses	0.565	± 0.2941
Test Soft Contact Lens B	0.512	± 0.2634
Test Soft Contact Lens C	0.511	± 0.2564

Change from baseline 36 months

Group	Value	95% CI
Spectacle Lenses	0.640	± 0.3199
Test Soft Contact Lens B	0.634	± 0.3249
Test Soft Contact Lens C	0.512	± 0.3072

Spherical Equivalent Refraction Primary · Baseline and every 6 months post-baseline up to 3 years

Spherical Equivalent Refraction was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 3 repeated measurements, each of which was the average of 3 consecutive readings, was used for the analysis. Higher values of spherical refraction indicate progression in Myopia.

Change from baseline 6 months

Group	Value	95% CI
Spectacle Lenses	-0.238	± 0.3443
Test Soft Contact Lens B	-0.327	± 0.3038
Test Soft Contact Lens C	-0.230	± 0.3436

Change from baseline 12 months

Group	Value	95% CI
Spectacle Lenses	-0.417	± 0.4557
Test Soft Contact Lens B	-0.456	± 0.3733
Test Soft Contact Lens C	-0.429	± 0.4199

Change from baseline 18 months

Group	Value	95% CI
Spectacle Lenses	-0.562	± 0.5841
Test Soft Contact Lens B	-0.692	± 0.3965
Test Soft Contact Lens C	-0.720	± 0.4988

Change from baseline 24 months

Group	Value	95% CI
Spectacle Lenses	-0.776	± 0.6185
Test Soft Contact Lens B	-0.781	± 0.4447
Test Soft Contact Lens C	-0.861	± 0.5504

Change from baseline 30 months

Group	Value	95% CI
Spectacle Lenses	-0.966	± 0.7592
Test Soft Contact Lens B	-1.000	± 0.5485
Test Soft Contact Lens C	-1.003	± 0.6829

Change from baseline 36 months

Group	Value	95% CI
Spectacle Lenses	-1.073	± 0.9922
Test Soft Contact Lens B	-1.266	± 0.3193
Test Soft Contact Lens C	-0.824	± 0.8244

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Spectacle Lenses

Serious: 0/51 (0%)

Deaths: —

Test Soft Contact Lens B

Serious: 0/51 (0%)

Deaths: —

Test Soft Contact Lens C

Serious: 0/50 (0%)

Deaths: —

Not Randomized

Serious: 0/13 (0%)

Deaths: —

Other adverse events (1 terms — click to expand)

Reaction	System	Spectacle Lenses	Test Soft Contact Lens B	Test Soft Contact Lens C	Not Randomized
Slit-lamp finding	Eye disorders	—	—	—	—

Data from ClinicalTrials.gov NCT01787760 adverse events section.

Sponsor's own description

This study is to investigate whether novel soft contact lens optical designs can slow myopia progression.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Interventions to slow progression of myopia in children.
   Walline JJ, Lindsley KB, Vedula SS, Cotter SA, et al · · 2020 · cited 128× · PMID 31930781 · DOI 10.1002/14651858.cd004916.pub4
2. Interventions for myopia control in children: a living systematic review and network meta-analysis.
   Lawrenson JG, Shah R, Huntjens B, Downie LE, et al · · 2023 · cited 117× · PMID 36809645 · DOI 10.1002/14651858.cd014758.pub2
3. Scoping review: Reporting characteristics for the safety of contact lenses in the pediatric population.
   Tomiyama ES, Kobia-Acquah E, Ansari SM, Logan AK, et al · · 2024 · cited 3× · PMID 38950144 · DOI 10.1097/opx.0000000000002156