E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Open angular glaucoma and ocular hypertension |
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E.1.1.1 | Medical condition in easily understood language |
glaucoma and ocular hypertension |
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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 compare goblet cell density when treating with a differently preserved travoprost eye drops in each eye |
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E.2.2 | Secondary objectives of the trial |
To compare eye pressure, ocular surface, tear film and symptoms of dry eyes when treating with a differently preserved travoprost eye drops in each eye |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
a. General criteria a. age ≥18 years b. danish speaking b. OHT or POAG c. Average IOP ≥ 22 mmHg after washout based on three measurements on each eye
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a. Generelle kriterier a. Alder ≥18 år b. Dansktalende b. OHT eller POAG c. Gennemsnitteligt tryk≥ 22 mmHg efter udvaskning udfra 3 målinger på hvert øje. |
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E.4 | Principal exclusion criteria |
a. History with significnat treatment required eye disease (including trauma) other than POAG or OHT b. Ocular surface disease based on fluorescein staining at inklusion c. Need for multidrug glaucoma treatment d. > 4 mmHg difference in IOP between eyes e. Corneal thickness <450 µm or >600 µm f. Treatment with systemic or lokal steroid within 3 months of study start g. Significant untreated systemic disease such as hypertension, heart failure, diabetes mellitus, stroke, lung disease and autoimmune disease. Diseases are acceptable if well-treated or if no treatment is required. h. Smoking at inklusion i. Pregnant or nursing. Pregnancy test will be performed on fertile women at inklusion. j. Women not using safe contraception. The following contraception is accepted and shall be used under the entire study period: IUD or hormonal contraception (pill, implant, transdermal bandaid, vaginal ring or injektion). Sterile and non-fertile women do not need to use contraception. To be considered non-fertile or sterile a woman must be sterilized through surgery (Bilateral Tubal Ligation, hysterectomy or bilateral ovariectomy) or be postmenopausal (defined as at least 12 months since last period before inklusion). After completing the study there will be no need to follow up on fertile women regarding potential pregnancy as the study medication has poor systemic absorption and does not have a teratogen effect. k. Known allergy towards active drug or additives in study medication. l. Patients unable to coorperate. |
a. Anamnese med betydende behandlingskrævende øjensygdom (inklusiv okulært traume) anden end glaukom og okulær hypertension b. Okulære overfladesygdomme ved fluorescein farvning ved inklusion c. Behov for flerstofsbehandling af glaukom d. Mere en 4 mmHg forskel mellem øjnene e. Corneatykkelse målt med pachymeter <450 µm eller >600 µm f. Behandling med systemisk eller lokalt binyrebarkhormon seponeret indenfor 3 mdr. fra forsøgsstart. g. Personer med betydende ubehandlet systemiske sygdomme fx hypertension, hjertesvigt, diabetes mellitus, tidligere cerebralt infarkt eller blødning, lungesygdomme samt autoimmune sygdomme. Sygdommene accepteres såfremt, de er velbehandlede eller ikke er behandlingskrævende h. Ryger på inklusionstidspunktet i. Gravide eller ammende. Graviditetstest udføres på fertile kvinder inden inklusion. j. Kvinder der ikke bruger sikker prævention. Følgende svangerskabsforebyggende midler anses som sikker antikonception, og skal bruges under hele forsøgsperioden: Spiral eller hormonel antikonception (p-piller, implantat, transdermal depotplastre, vaginalring eller depotinjektion). Sterile eller ikke fertile forsøgsdeltagere er fritaget for kravet om brug af antikonception. For at betragtes som steril eller ikke fertil, må man almindeligvis være kirurgisk steriliseret (vasektomi/bilateral tubektomi, hysterektomi og bilateral ovarektomi) eller være postmenopausal, defineret som udebleven menstruation i mindst 12 måneder før studie indrullering. Efter afslutning af forsøget er der ikke behov for at følge fertile kvinder mhp. graviditet, da forsøgsmedicinens systemiske optag er ringe og ikke anses for at være teratogent. k. Personer med allergi overfor indholdsstofferne i medicin, der gives under forsøget l. Forsøgspersoner, der ikke kan samarbejde til undersøgelse |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Intraocular pressure lowering effect Corneal and conjunctival surface Mucin in tear film Symptoms of dry eyes |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |