| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
|
| 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 |
| The objective of this study is to identify the concentration and daily dosing frequency (2% once per day [QD] and 0.3%, 1%, 2% twice per day [BID]) of BOL-303242-X ophthalmic suspension with the most favorable safety and efficacy profile in treating dry eye syndrome over a 12 week dosing period. |
|
| E.2.2 | Secondary objectives of the trial |
Primary Safety Endpoint:
• the percent of subjects with treatment emergent ocular AEs.
Key Secondary Efficacy Endpoints:
• total corneal staining score as determined by the sum of fluorescein staining scores in each of the five corneal regions (a 4-point scale, 0-3, for each region)
• worst VAS dry eye symptom as determined for each subject separately at Visit 2 (Baseline)
|
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Subjects who are at least 18 years of age at screening.
2. Subjects must have the ability to understand and sign an informed consent form (ICF) and those enrolled in the US must provide Health Insurance Portability and Accessibility Act (HIPAA) authorization.
3. Subjects who have a diagnosis of dry eye disease, defined by Visit 2 (Baseline) as follows:
a. Subjective symptoms of dry eye for at least 6 months as confirmed by an affirmative response to the question “For the past 6 months or longer, have you had dry eyes?”
AND
b. Schirmer test without anesthesia: 1 mm and 7 mm (after 5 minutes, with eyes closed), in at least 1 eye;
AND
c. Sum of corneal fluorescein staining score of 4 (NEI Scale) in at least 1 eye
4. Intraocular pressure (IOP) ≤28 mmHg with no IOP lowering medications.
5. Subjects who are willing and able to refrain from using contact lenses during the study.
6. Subjects who are willing and able to refrain from using any topical ocular medications other than the study medication, and the Sponsor-provided ART during the study.
7. Current or recent use of systemic medications that could affect dry eye condition is permitted, provided subjects have been on a stable dose for ≥30 days (from screening visit) and are anticipated to remain on stable doses over the duration of the study.
8. Best-corrected visual acuity (BCVA), using Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol of + 0.7 logMar units (Snellen equivalent ~20/100) or better in OU.
9. Women who are not of childbearing potential or who have a negative urine pregnancy test result at screening and on the day of randomization.
10. Subjects who are able and willing to comply with all treatment and follow-up procedures.
|
|
| E.4 | Principal exclusion criteria |
1. Subjects with known hypersensitivity or contraindication to any component of the study medication.
2. Subjects who are expected to require concurrent treatment with ophthalmic medications (prescription or over the counter) including cyclosporine, antibiotics, and glaucoma medications.
3. Subjects who are expected to require treatment with corticosteroids during the study.
4. Subjects who have used topical or systemic isotretinoin, cyclosporine, or retinoid therapies within 30 days prior to the screening visit.
5. Planned initiation of, or changes to, concomitant medication that could affect dry eye within 30 days of screening visit or during study.
6. Ocular disorders that may confound interpretation of study results such as significant corneal surface disease not caused by dry eyes, abnormal corneal sensitivity, abnormal tear spreading, including but not limited to the following:
a. Abnormal lid function, lid position, or blink rate, that in the opinion of the Investigator is clinically significant
b. Entropion, ectropion, trichiasis, distichiasis, lagophthalmos, neuroparalytic keratitis, and significant thyroid eye disease causing exposure keratopathy.
c. History of herpetic keratopathy.
d. Subjects currently on treatment for allergic eye disease (including subjects on topical ophthalmic mast cell stabilizers and antihistamines within 1 month of the screening visit).
e. Active ocular infection or non keratoconjunctivitis sicca inflammation.
f. Significant conjunctival scarring from any cause (eg, mucous membrane pemphigoid or Steven’s Johnson syndrome).
g. Pterygium, pinguecula (non inflamed pinguecula which do not encroach on the cornea can be included, but the conjunctiva affected by pinguecula will be excluded when grading staining).
h. Congenitally absent lacrimal gland.
i. Unresolved epitheliopathy or corneal abrasion.
j. Neurotrophic keratitis.
k. LASIK /refractive surgery within the past 12 months.
l. History of corneal graft surgery.
m. Keratoconus.
7. Subjects who have a corneal stromal scar greater than 1 mm involving the visual axis.
8. Subjects who have undergone any type of ocular surgery within three months prior to screening.
9. Lacrimal punctal occlusion (plugs or cautery) within 2 months of Screening Visit. Subjects who started the study with permanent (non collagen) plugs should remain on plugs during the study (ie, lost plugs must be replaced at the earliest opportunity).
10. Subjects with glaucoma, as diagnosed by the Investigator.
11. Subjects who are monocular (defined as having only one eye with vision better than or equal to +1.0LogMar or one eye is absent).
12. Subjects who are sexually active and who do not fall into one of the following categories:
a) postmenopausal
b) surgically sterile
c) using one of the following birth control methods throughout the duration of the study:
- intrauterine device (> 14 days)
- barrier method (condom or diaphragm) with spermicide (> 14 days)
- hormonal contraception (same dose and same formulation for at least six months).
13. Women who are pregnant, breastfeeding, or planning on becoming pregnant during the study.
14. Subjects with a history or presence of chronic generalized systemic or ocular disease that the Investigator feels might increase the risk to the subject or confound the result of the study.
15. Subjects who have participated in an investigational drug or device research study within 30 days prior to the screening visit or while participating in this study.
16. Subjects who were previously randomized into this study.
17. Subjects with any condition (medical or ocular) which in the opinion of the Investigator could interfere with the effective conduct of the study or with the interpretation of the results
|
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
Primary Safety Endpoint:
• the percent of subjects with treatment emergent ocular AEs.
Key Secondary Efficacy Endpoints:
• total corneal staining score as determined by the sum of fluorescein staining scores in each of the five corneal regions (a 4-point scale, 0-3, for each region)
• worst VAS dry eye symptom as determined for each subject separately at Visit 2 (Baseline)
|
|
| 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 | Yes |
| 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.8.3 |
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 | 4 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
| 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
|
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 0 |
| 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 | 0 |
| E.8.9.2 | In all countries concerned by the trial months | 12 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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