E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ocular hypertension or Open angle glaucoma |
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E.1.1.1 | Medical condition in easily understood language |
Ocular hypertension and glaucoma. |
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E.1.1.2 | Therapeutic area | Body processes [G] - Ocular Physiological Phenomena [G14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10018307 |
E.1.2 | Term | Glaucoma and ocular hypertension |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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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 |
The objective of this study is to assess the efficacy and tolerability of TRAVATAN® Solution without BAK, containing Polyquad® Preservative versus LUMIGAN® 0.01% Solution in treatment naïve patients with ocular hypertension or open angle glaucoma. |
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E.2.2 | Secondary objectives of the trial |
For the secondary analysis, changes in the following study variables will be assessed: Ocular Hyperemia grading, Tear Film Break Up Time, Ocular Surface Disease Index (OSDI), Ocular Staining (before and after 6 months of PGA therapy) and the percentage of patients who reach target IOP (≤18 mmHg) after 6 months of PGA therapy. The following exploratory variables will also be evaluated: Assessing both conjunctival epitheliai cells and goblet cells in impression cytology specimens before and after 6 months of PGA therapy and Assessing the expression of both HLA-DR (an inflammatory marker) and MUC5AC (a protein found in goblet cells) in impression cytology specimens by flow cytometry before and after 6 months of PGA therapy. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Must be at least 18 years of age.
2. Must be diagnosed with either open-angle glaucoma or ocular hypertension in at least one eye and be treatment naïve to any glaucoma treatment.
3. Must have an IOP between 19 mmHg and 35 mmHg in at least one eye, which would be the study eye.
4. Must have IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
5. Must have a baseline a tear film break up time (TBUT) of ≥ 5 seconds.
6. Must have a baseline ocular staining grade of < III (i.e. between 0 and II) based on Oxford scale.
7. In case one eye is not included in the study, the IOP should be able to be controlled on no pharmacologic therapy or on the study medicine alone.
8. Must be able to follow instructions and be willing and able to attend all study visits.
9. Must have best corrected Snellen visual acuity of 6/60 (20/200, 1.0 LogMAR) or better in each eye.
10. An Ethics Committee reviewed and approved (for use in this study) informed consent form must be read, signed, and dated by the participating patient, as well as signed and dated by the individual (Principal Investigator or other site personnel) obtaining the informed consent, before conducting the Screening Visit and prior to initiation of study procedures.
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E.4 | Principal exclusion criteria |
1. Known medical history of allergy, hypersensitivity or poor tolerance to any components of the study medications to be used in this study that is deemed clinically significant in the opinion of the Principal Investigator.
2. Any abnormality preventing reliable applanation tonometry in either eye.
3. Corneal dystrophies in either eye.
4. Any opacity or patient uncooperativeness that restricts adequate examination of the anterior chamber of either eye.
5. Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
6. History of severe dry eye, keratoconjunctivitis sicca, ocular pemphigoid or Stevens-Johnson syndrome.
7. Prior treatment of dry eye with punctal plugs, punctal cautery, Restasis® or topical ocular corticosteroids.
8. History of ocular surface disease (dry eye) or current/prior use of dry eye medications (either over-the counter or prescription medications)
9. Contact lens wearers are excluded
10. Intraocular conventional surgery or laser surgery in either eye that is less than three months prior to the Screening Visit.
11. Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator’s best judgment.
12. Progressive retinal or optic nerve disease from any cause.
13. A history of, or at risk for uveitis or cystoid macular edema (CME).
14. Use of any systemic medications known to affect IOP (e.g., oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for at least 7 days prior to Screening Visit or an anticipated change in the dosage during the course of the study.
15. Women of childbearing potential not using reliable means of birth control. A reliable effective method of birth control must have been used for at least one month prior to Visit 1 and is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner.
16. Women who are pregnant or lactating
17. Unwillingness to risk the possibility of darkened iris or eyelash changes.
18. A condition, which in the opinion of the Principal Investigator, would interfere with optimal participation in the study, or which would present a special risk to the patient.
19. Participation in any other investigational study within 30 days prior to the Screening Visit.
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E.5 End points |
E.5.1 | Primary end point(s) |
Mean Change in IOP from baseline between both treatment. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Month 3 and Month 6 visits. |
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E.5.2 | Secondary end point(s) |
Change in Ocular Hyperemia grading after 6 months of PGA therapy between both treatment groups; Change in Ocular Surface Disease Index after 6 months of PGA therapy between both treatment groups; Change in tear film break up time (after 6 months of PGA therapy) between both treatment groups; Change in ocular staining (after 6 months of PGA therapy) between both treatment groups Percentage of patients who reach target IOP (≤ 18 mmHg) between both treatment groups. An interim analysis of all study variables will be conducted at the 3 month visit. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Month 3 and Month 6 visits. |
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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 | No |
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
| 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 | 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 | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |