E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with eye pain associated to dry eye |
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E.1.1.1 | Medical condition in easily understood language |
Patients with eye pain associated to dry eye |
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E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
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 assess the analgesic effect of different doses of SYL1001 ophthalmic solution.
- Ocular tolerance at the site of administration (cornea and conjunctiva) after 10 days of treatment. |
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E.2.2 | Secondary objectives of the trial |
? Assessment of systemic tolerance. Impact of the treatment (change from the baseline) in blood and urine parameters, the physical examination and in vital signs after 10 days of treatment.
? Assessment of local tolerance. Impact of the treatment (change from the baseline) in ocular parameters (visual acuity, intraocular pressure (IOP), Schirmer?s test and tear break-up time)
? Assessment of Adverse Events (AEs) occurred |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients aged ? 18 years
- Men or women (individuals of either sex can participate in the study)
- Have submitted their written consent to participate in the study, after having received all information relating to the design, aims and possible risks resulting therefrom.
- Common symptoms of persistent, daily, mild to moderate dry eye lasting more than three months.
o OSDI scale between 13-70
o VAS scale between 2 ? 7
- Eye tests in both eyes until 15 days before inclusion:
o Corneal fluorescein staining. Oxford scale > 0
o Tear break-up time (TBUT) < 10 seconds
o Schirmer?s test with anaesthesia < 10 mm/5min |
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E.4 | Principal exclusion criteria |
- Women who are pregnant or breastfeeding or who have a positive urine pregnancy test. Women who do not commit to use a medically acceptable method of contraception from the time of selection and throughout the study.
- Any current, relevant disease, including respiratory disease, cardiovascular disease, endocrine disease, neurological disease, haematological disease, kidney disease, oncological disease, liver disease, gastrointestinal dysfunction, hypertension or active acute infectious processes.
- Previous chronic or recurrent processes which, according to the investigator, could affect the development of the study.
- Concomitant use of other medications with analgesic activity by any route of administration at the time of entry into the study.
- Change in any concomitant eye and/or systemic medication of the patient one month before the study and during the study.
- Changes in the pre-established administration schedule of artificial tears during the 15 days before the study and during the 10 days of the study.
- Initiation of treatment with cyclosporine or changes in the dosage or administration schedule of cyclosporine within the 6 months before inclusion in the study.
- History of hypersensitivity to drugs.
- Use of contact lenses during the treatment and previous 15 days.
- History of drug abuse or drug or alcohol dependence.
- Laboratory abnormalities which, in the investigator?s opinion, are clinically significant.
- Previous refractive surgery.
- Having participated in another clinical trial within the 2 months prior to inclusion.
- Another eye disease that is significant in the investigator?s opinion. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Assessment of the analgesic effect
- The change from the baseline scoring on the VAS scale after 10 days of treatment.
- The change from the baseline in the scoring of the OSDI questionnaire after 10 days of treatment.
Assessment of local tolerance
- The frequency of new abnormalities occurring at the site of administration (cornea and conjunctiva) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 10 days of treatment |
Tras 10 días de tratamiento |
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E.5.2 | Secondary end point(s) |
Assessment of systemic tolerance. The impact of treatment (change from the baseline) in the blood and urine parameters, the physical examination and in vital signs after 10 days of treatment.
The impact of treatment (change from the baseline) in the remaining local tolerance parameters (anterior eye examination, visual acuity and IOP) after 10 days of treatment.
Assessment of AEs. All AEs occurring during the study will be recorded. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After 10 days 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 | Yes |
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) | 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.8.2.4 | Number of treatment arms in the trial | 3 |
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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 6 |
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 | 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 |