E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
inflammation of the eye follwoing cataract surgery |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10015943 |
E.1.2 | Term | Eye inflammation |
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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 |
Identify the most effective drug concentration and dose frequency of BOL-303242-X ophthalmic suspension, for the treatment of inflammation following cataract surgery. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subjects must be at least 18 years of age on the date the Informed Consent Form (ICF) is signed and with the capacity to voluntarily provide consent.
2. Subjects must be able to understand and provide written consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide authorization as appropriate for local privacy regulations.
3. Subjects who are candidates for routine, uncomplicated cataract surgery (phacoemulsification with posterior chamber intraocular lens [IOL] implantation, not combined with any other surgery) in the study eye.
4. Subjects who, in the Investigator’s opinion, have potential postoperative pinholed Snellen visual acuity (VA) of at least 20/200 or pinholed Decimal VA of 0.1 in the study eye.
5. Subjects who are not of childbearing potential or female subjects who have a negative urine pregnancy test result at screening.
6. Subjects must be able and willing to comply with all treatment and follow-up procedures.
Inclusion criteria at Visit 3 (Postoperative Day 1): 7. Subjects who have undergone routine, uncomplicated cataract surgery (phacoemulsification with posterior chamber IOL implantation, not combined with any other surgery) in the study eye.
8. Subjects who have ≥Grade 2 anterior chamber (AC) cells in the study eye
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E.4 | Principal exclusion criteria |
1. Subjects who are expected to require concurrent ocular therapy (either eye) with nonsteroidal anti-inflammatory drugs (NSAIDs), mast cell stabilizers, antihistamines, or decongestants throughout the duration of the study or have used any of the above within 2 days prior to surgery in either eye.
2. Subjects who are expected to require treatment with systemic NSAIDs throughout the duration of the study with the exception of ≤81 mg/day of acetylsalicylic acid.
3. Subjects who are expected to require treatment with any systemic (eg, oral, parenteral, inhaled, dermal, etc) or ocular (either eye) corticosteroids or glucocorticoids throughout the duration of the study or have used any systemic or ocular corticosteroids within 3 months prior to screening in either eye.
4. Subjects who are expected to require concurrent ocular therapy with immunosuppressants (eg, Restasis) throughout the duration of the study or have used ocular immunosuppressants within 30 days prior to surgery in either eye.
5. Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components.
6. Subjects who have a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result of the study.
7. Subjects who have a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator’s opinion, may preclude study treatment or follow-up.
8. Subjects with elevated IOP (≥21 mm Hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye at screening.
9. Subjects who are monocular or have pinholed Snellen VA 20/200 or pinholed Decimal VA of 0.1 or worse in the non-study eye.
10. Subjects who have had ocular surgery (including laser surgery) in the study eye within 3 months or in the fellow eye within 2 weeks prior to the Screening Visit.
11. Subjects who are sexually active and who do not fall into one of the following categories: • Postmenopausal for at least 2 years • Surgically sterile • 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 6 months)
12. Women who are pregnant or breastfeeding.
13. Subjects participating in any drug or device clinical investigation within 30 days prior to entry into this study.
14. Subjects who were previously randomized in this study.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint for this study is the proportion of subjects with complete resolution of AC cells at Visit 5 (Postoperative Day 8). Complete resolution of AC cells is defined as Grade 0 cells |
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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 | 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 |
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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 | 4 |
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 | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |