E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Meibomian gland dysfunction Dry eye syndrome |
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E.1.1.1 | Medical condition in easily understood language |
Meibomian gland dysfunction Dry eye syndrome |
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E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10065062 |
E.1.2 | Term | Meibomian gland dysfunction |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10013777 |
E.1.2 | Term | Dry eye syndrome |
E.1.2 | System Organ Class | 100000014904 |
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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 compare the effect of treatment with topical azithromycin or oral doxycycline on tear film thickness in patients with dry eye syndrome caused by meibomian gland dysfunction |
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E.2.2 | Secondary objectives of the trial |
To compare the effect of treatment with topical azithromycin or oral doxycycline in patients with dry eye syndrome caused by meibomian gland dysfunction on - Lipid layer thickness - Break up time (BUT) - Visual Acuity - Tear film osmolarity - Staining of the cornea with fluorescein - Impression cytology - Schirmer I test - Subjective symptoms of dry eye syndrome (OSDI© questionnaire) - Intraocular pressure - Meibography - Conjuctival staining with lissamine green - Corneal sensitivity - Signs and symptoms of MGD |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Men and women aged over 18 years - Signs of meibomian gland plugging or expressibility of the meibomian glands. - DES most likely caused by MGD, no other cause identifiable which is more likely (e.g. intake of concomitant medication that could induce DES, systemic diseases such as systemic arthritis or diabetes), as judged by the investigator - Signed and dated written informed consent. - History of dry eye syndrome for at least 3 months - Normal ophthalmic findings except dry eye syndrome and MGD, ametropia < 6 Dpts - BUT</= 10 seconds
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E.4 | Principal exclusion criteria |
- Participation in a clinical trial in the 3 weeks before the screening visit - Symptoms of a clinically relevant illness in the 3 weeks before the first study day - Presence or history of a severe medical condition that will interfere with the study aim as judged by the clinical investigator - Sjögren’s syndrome - Stevens-Johnson syndrome - Presence or history of a severe ocular condition that will interfere with the study aim as judged by the clinical investigator - Treatment with corticosteroids in the 4 weeks preceding the study - Wearing of contact lenses - Topical treatment with any ophthalmic drug in the 4 weeks preceding the study except topical lubricants - Ocular infection - Ocular surgery in the 6 months preceding the study - Pregnancy, planned pregnancy or lactating - Contraindicaton against the use of topical azithromycin or oral doxycycline
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint will be the difference in tear film thickness between the two groups after treatment |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
2, 4 and 6 weeks after start of treatment |
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E.5.2 | Secondary end point(s) |
Difference between the two groups after treatment:
- Lipid layer thickness - Break up time (BUT) - Visual Acuity - Tear film osmolarity - Staining of the cornea with fluorescein - Impression cytology - Schirmer I test - Subjective symptoms of dry eye syndrome (OSDI© questionnaire) - Intraocular pressure - Meibography - Conjuctival staining with lissamine green - Corneal sensitivity - Signs and symptoms of MGD |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
2, 4 and 6 weeks after start of treatment |
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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 | 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 | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |