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

• Conditions: Cycloplegia for objective refraction measurement; MedDRA version: 18.1Level: PTClassification code 10001906Term: AmblyopiaSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2015-000268-32-DE
• Lead Sponsor: niversitätsklinikum Erlangen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-05
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Comparison of extent of cycloplegia after tropicamide vs. cyclopentolate;Secondary Objective: Comparison of extent of astigmatism after tropicamide vs. cyclopentolate<br>Comparison of extent of mydriasis after tropicamide vs. cyclopentolate<br>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 Outcome Measures

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