NCT01070381CompletedNot Applicable
Daily Disposable Toric Comparative Trial in Europe
CIBA VISION0 sites220 target enrollmentStarted: January 1, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 220
- Primary Endpoint
- Overall Comfort
Study Overview
Brief Summary
The purpose of this study is to investigate the subjective and objective performance of two daily disposable lenses for wearers with astigmatism.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Current soft contact lens wearers able to be fit with soft toric lenses in the protocol-specified parameters.
- •Achieve 0.5 or better distance visual acuity in each eye at time of dispense.
- •Achieve acceptable or optimal fit in each eye at time of dispense.
- •Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- •Habitual daily disposable contact lens wearer.
- •Sleeps in contact lenses overnight.
- •Currently enrolled in an ophthalmic clinical trial.
- •Other protocol-defined exclusion criteria may apply.
Outcomes
Primary Outcomes
Overall Comfort
Time Frame: 1 week of wear
Overall Comfort, as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall comfort is measured on a 10-point scale, with 1 being poor and 10 being excellent.
Secondary Outcomes
No secondary outcomes reported
Investigators
Similar Trials
Completed
Phase 1
A Trial Comparing the Pharmacokinetic Properties of Faster-acting Insulin Aspart (FIAsp) After Different Injection Regions and Routes of Administration in Healthy SubjectsHealthyDiabetesNCT02089451Novo Nordisk A/S21
Completed
Phase 1
A Comparative Trial Focusing on Injections With the Medical Device DV3316 Pen-injector Versus FlexPen®DiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2NCT02627287Novo Nordisk A/S150
Completed
Phase 1
A Trial Investigating the Pharmacokinetic Properties of Formulations of NN1218 in Subjects With Type 1 DiabetesDiabetes Mellitus, Type 1DiabetesNCT01469143Novo Nordisk A/S40
Completed
Phase 1
A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp When Administered as a Bolus in a Continuous Subcutaneous Infusion Regimen in Subjects With Type 1 DiabetesDiabetesDiabetes Mellitus, Type 1NCT01992588Novo Nordisk A/S48
Completed
Phase 1
Comparison of Explorative Formulation of Insulin Degludec and Insulin Aspart Co-formulation Versus Explorative Formulation of Insulin Degludec and Insulin Aspart Separately Compared With Biphasic Insulin Aspart 30 in Male Subjects With DiabetesDiabetes Mellitus, Type 2DiabetesDiabetes Mellitus, Type 1NCT01865305Novo Nordisk A/S59
