E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
asymptomatic allergic conjunctivitis |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10010744 |
E.1.2 | Term | Conjunctivitis allergic |
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 |
To evaluate the ocular safety of Olopatadine HCl Solution, 0.77% compared to Vehicle in subjects 2 years of age and older with asymptomatic eyes, when administered once daily in
both eyes for up to 6 weeks. |
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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 |
• 2 years of age and older
•Able and willing to comply with study protocol and follow protocol instructions.
• Adequate birth control methods for the duration of the study.
• Best-corrected visual acuity (BCVA) of 55 or greater in each eye.
• Willing to avoid contact lens wear during each of the study visits; contact lens wear also should be stable and consistent for
1 month prior to Visit 1 and expected to remain the same for the study duration.
• Willing and able to sign an Informed Consent form.
•Other protocol-specified inclusion criteria may apply. |
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E.4 | Principal exclusion criteria |
• Women of childbearing potential that are pregnant, breastfeeding, or not in agreement to use adequate birth control
methods to prevent pregnancy throughout the study.
• Evidence of contact lens care solution related ocular surface damage or giant papillary conjunctivitis (GPC).
• Any ocular infection (bacterial, viral or fungal) or history of ocular Herpes (simplex or zoster) or adenoviral infection in either
eye or have had any ocular infection within 30 days prior to Visit 1.
• Using systemic medication(s) on a chronic dosing regimen for less than 30 days or changed dosage of this medication
within 30 days prior to Visit 1.
• Current or past history of glaucoma, hypotony (i.e, IOP 5mmHg) or ocular hypertension.
• History of retinal detachment, diabetic retinopathy, or progressive retinal disease.
• Presence of ocular conditions that may affect the study outcomes.
• Corneal conditions affecting the corneal structure.
• History or evidence of any ocular surgical procedure within 1 year prior to Visit 1.
• Current or recent medical conditions that, in the opinion of the Investigator, would preclude safe participation in the study.
• Prior, current, or anticipated use of ophthalmic agents other than investigational product during study participation.
• Participation in any investigational study within 30 days prior to Visit 1 or concomitantly with this study.
• Known contraindications or hypersensitivities to any of the study medications or their components.
• Other protocol-specified exclusion criteria may apply. |
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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) |
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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 | No |
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) | Yes |
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 | 2 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA 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.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 14 |