E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Keratoconus affects the young, presenting in adolescence with impaired vision. This distortion of vision is due to the forward bowing of the weakened cornea. This is thought to be due to a congenital anomaly as there can be a family history. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the efficacy of riboflavin (vitamin B2) 0.1% eye drops and ultraviolet A light (UVA) at 370nm to cause photochemical collagen cross-linkage to strengthen the cornea and prevent the progression of keratoconus. |
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E.2.2 | Secondary objectives of the trial |
To determine whether Riboflavin/UVA corneal cross-linkage can reverse some of the bowing of the cornea caused by keratoconus |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Age 18 to 70 Must fully understand the investigative nature of the study Moderate to advanced bilateral keratoconus No known allergies to pre- and post-operative medications Willingness to attend for follow-up examinations |
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E.4 | Principal exclusion criteria |
Age below 18 Other pre-existing ophthalmic pathology Previous ophthalmic surgeryUnilateral keratoconus Severe keratoconus in which the cornea is so distorted that accurate refractive and corneal measurements cannot be obtained (in these eyes data confirming stability or progression is not possible) |
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E.5 End points |
E.5.1 | Primary end point(s) |
To determine whether Riboflavin/UVA corneal cross-linkage can prevent the progression of keratoconus. Efficacy parameters will be determined by comparing the pre- and postoperative refractive power (diopters), astigmatic power (analyzed by vector analysis), unaided and best spectacle corrected visual acuities (Logmar),corneal power in the 3mm, 5mm and 7mm central zones (assessed by corneal topography) and the inferior versus superior power differences (diopters) within these zones using paired t-tests. Data will be analyzed using paired and unpaired t-tests with quantatative continuous data such as visual, refractive and corneal power changes and with chi squared analysis with non-continuous data. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Patients other eye will act as the control. |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of last patient |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |