E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
acute adenoviral keratoconjunctivitis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10014975 |
E.1.2 | Term | Epidemic keratoconjunctivitis |
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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 evaluate the efficacy of GV 550 versus placebo to treat acute adenoviral keratoconjunctivitis •2 primary criteria will be assessed (evolution between D0 and D4) : - Evolution of the inflammation assessed by subjective signs score (tearing + foreign body sensation + photophobia) and objective signs score (conjunctival injection + conjunctival chemosis + punctate epithelial keratitis) - Viral load by quantitative PCR.
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E.2.2 | Secondary objectives of the trial |
• Other assessed criteria: - Patient’s symptomatology evaluation (VAS) - Score of each subjective signs (tearing, foreign body sensation, photophobia, pain, itching) - Score of each objective signs (NEI score, Van bijsterveld score, BUT , Schirmer test values, Slit lamp examination) - Existancy of focal corneal subepithelial infiltrates (nummular stromal infiltration) - Existancy of pseudo-membranes - Virus load between D0-D10
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Written informed consent Male or female aged from 18 to 80 years old Acute adenoviral keratoconjunctivitis clinically diagnosed on the basis of: • First episode • With an history of unilateral occurrence • Recent (first symptoms lasting less than 3 days) • Conjunctival injection • Tearing • Without infiltrates • Without purulent secretion • With positive rapid test diagnosis (RPS Adeno-detector®)
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E.4 | Principal exclusion criteria |
•Active ocular allergy, Ocular herpes disease •History of bacterial conjunctivitis / blepharoconjunctivitis within the last month before the inclusion visit •Any relevant ocular anomaly interfering with ocular surface: chemical burns, corneal distrophy, orbital radiotherapy, progressive involvement after traumatism, etc……. •Best far corrected visual acuity ≤ 1/10 •By questioning: Any known medical or surgical history, disorder or disease such as acute or chronic severe organic disease •Known hypersensitivity to one of the components of the study products. •Pregnancy, lactation for women •Non compliant patient (e.g. not willing to attend the follow-up visits, way of life interfering with compliance, man who is not using a local contraceptive method such as condom). |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary variable is the change between Day 0 and Day 4 (value at Day 4 minus value at Day 0) of the inflammation for both eyes assessed by subjective signs score (tearing + foreign body sensation + photophobia) and objective signs score (conjunctival injection + conjunctival chemosis + punctate epithelial keratitis). |
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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 | No |
E.6.4 | Safety | Yes |
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 | No |
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 | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
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 | No |
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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the end of the study will be the last visit of the last subject |
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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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |