Clinical study comparing the effect of tropicamid eyedrops with cyclopentolat eyedrops for the assessment of bad eyesight in 4-6-year old children

Prospective, open-label, randomised, single-centre, two-arm, parallel-group, cross-over controlled clinical study, phase 4, to investigate the efficacy of tropicamid 0.5% eyedrops compared to cyclopentolat 0.5% eyedrops for cycloplegia for objective refraction measurement of the eye in 4- to 6-year old children

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000268-32-DE

Enrollment

Registered

2015-06-05

Start date

2015-08-12

Completion date

Unknown

Last updated

2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cycloplegia for objective refraction measurement MedDRA version: 18.1 Level: PT Classification code 10001906 Term: Amblyopia System Organ Class: 10015919 - Eye disorders

Interventions

Pharmaceutical Form: Ear/eye drops, solution INN or Proposed INN: Tropicamide Other descriptive name: TROPICAMIDE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Girls and boys 4 to 6 years of age Indication for objective refraction measurement Are the trial subjects under 18? yes Number of subjects for this age range: 50 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Other medication within 7 days prior to screening Down syndrome Cerebral lesion in medical history Epilepsy in medical history Severe organic impairment in medical history Mechanical stenosis of the gastro-intestinal tract in medical history

Design outcomes

Primary

Measure	Time frame
Main Objective: Comparison of extent of cycloplegia after tropicamide vs. cyclopentolate;Secondary Objective: Comparison of extent of astigmatism after tropicamide vs. cyclopentolate Comparison of extent of mydriasis after tropicamide vs. cyclopentolate Comparison of safety and tolerability after tropicamide vs. cyclopentolate;Primary end point(s): Sphaeric equivalent of refraction after tropicamide vs. cyclopentolate;Timepoint(s) of evaluation of this end point: 30 min after last local IMP application	—

Measure

Time frame

Main Objective: Comparison of extent of cycloplegia after tropicamide vs. cyclopentolate;Secondary Objective: Comparison of extent of astigmatism after tropicamide vs. cyclopentolate Comparison of extent of mydriasis after tropicamide vs. cyclopentolate Comparison of safety and tolerability after tropicamide vs. cyclopentolate;Primary end point(s): Sphaeric equivalent of refraction after tropicamide vs. cyclopentolate;Timepoint(s) of evaluation of this end point: 30 min after last local IMP application

—

Secondary

Measure	Time frame
Secondary end point(s): Extent fo astigmatism after tropicamide vs. cyclopentolate Extent of mydriasis after tropicamide vs. cyclopentolate Frequency of AEs after tropicamide vs. cyclopentolate Change in heart rate after tropicamide vs. cyclopentolate;Timepoint(s) of evaluation of this end point: 30 min after last local IMP application	—

Countries

Germany

Contacts

Public ContactAugenklinik

Universitätsklinikum Erlangen

gabriele.gusek-schneider@uk-erlangen.de004991318544489

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026