Multicentre, Randomised, Double-Blind, Vehicle and Active-Controlled Phase Iii Study Evaluating the Efficacy and Safety of Ketotifen Ophthalmic Solution 0.5 Mg/Ml Compared to Vehicle and Ketoftil (Ketotifen Ophthalmic Solution 0.5 Mg/Ml) for the Treatment of Seasonal Allergic Conjunctivitis.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Genetic S.p.A.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

31 May 2023 → 21 Oct 2024

Decision date (initial)

2023-05-05

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2023-503185-23-00

WHO UTN

U1111-1287-0217

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

MULTICENTRE, RANDOMISED, DOUBLE-BLIND, VEHICLE AND ACTIVE-CONTROLLED PHASE III STUDY EVALUATING THE EFFICACY AND SAFETY OF KETOTIFEN OPHTHALMIC SOLUTION 0.5 MG/ML COMPARED TO VEHICLE AND KETOFTIL (KETOTIFEN OPHTHALMIC SOLUTION 0.5 MG/ML) FOR THE TREATMENT OF SEASONAL ALLERGIC CONJUNCTIVITIS.

Conditions and MedDRA coding

SEASONAL ALLERGIC CONJUNCTIVITIS

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Adult patient (age from 18 to 65 years old).
2. Diagnosis of SAC assess through skin test and/or validated IgE radioallergosorbent test (RAST) to the relevant seasonal allergy for the geographic area within the past 12 months.
3. Experiencing symptoms or exceeding an appropriate minimum level of symptoms at the time of enrolment (Patients must have at least one of Redness, tearing, itchy eyes, eyelid swelling, conjunctival chemosis with a grade score of one)
4. Patient has given written informed consent approved by the Ethics Committee (EC).

Exclusion criteria 17

1. Diagnosis of any ocular pathology other than acute SAC (dry eye, chronic allergic conjunctivitis, VKC, viral or bacterial conjunctivitis).
2. Use of prostaglandin for Glaucoma treatments in the last 1 month.
3. Use of cyclosporine eyedrops for severe dry eye.
4. Female patient: pregnant, lactating or planning pregnancy within next 12 months (Female of child-bearing potential will undergo urine pregnancy test).
5. Participation in a clinical trial in which an investigational drug or device was administered in the 30 days prior to screening or 5 half-lives of the study drug, whichever is longer.
6. Patient legally or mentally incapacitated unable to give informed consent for the participation in this study.
7. Patient who is unable or unwilling to comply with the appointments or with all the requirements of the Protocol.
8. Use of contact lenses during the course of the study.
9. History of ocular surgery or laser within the previous 3 months.
10. Best corrected visual acuity (Snellen) in either eye worse than 20/100.
11. Patients who have received anti-allergy immunotherapy (desensitising subjects with increase of allergen challenges) in the previous two years or are still receiving this kind of therapy.
12. History of Hypersensitivity to other anti-allergic agents (including corticosteroids).
13. Use of non-steroidal anti-inflammatory agents, mast cell stabilizers, antihistamines, decongestants, or α-adrenoreceptor antagonists.
14. Use of topical (ocular) or systemic corticosteroids.
15. Any other medical condition that could have interfered with the results of the study.
16. History of Hypersensitivity related to the study IMPs, including any of the excipients.
17. Female of potential child-bearing that does not use at least one effective contraceptive method for the entire study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. To evaluate Ocular Itching between V1 (baseline) and V5 (14 days) later Ketotifen/ Ketoftil®/Placebo administrations. Ocular itching scores will be self-assessed by the participants using a 5-point scale.

Secondary endpoints 5

1. To evaluate Conjunctival Redness at 30 minutes, 2 days, 7 days, 14 days later the first Ketotifen/Ketoftil®/Placebo administrations. Conjunctival redness will be assessed by the Investigator using the Efron scale.
2. To evaluate tearing and eyelid swelling at 30 minutes, 2 days, 7 days, 14 days later the first Ketotifen/Ketoftil®/Placebo administrations. Tearing and eye swelling will be assessed by the Investigator using a 4-point scale
3. To evaluate conjunctival chemosis at 30 minutes, 2 days, 7 days, 14 days later the first Ketotifen/Ketoftil®/Placebo administrations. Conjunctival chemosis will be assessed by the Investigator using a 3-point scale.
4. To evaluate the product tolerability at 30 minutes, 2 days, 7 days, 14 days later the first Ketotifen/Ketoftil®/Placebo administrations. Product tolerability will be assessed by the Investigator using the Visual Analog Scale (VAS).
5. Quantitative and Qualitative Evaluation of Safety in terms of adverse events reported.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Genetic S.p.A.

Sponsor organisation

Genetic S.p.A.

Address

Via Giuseppe Della Monica 26

City

Castel San Giorgio

Postcode

84083

Country

Italy

Scientific contact point

Organisation

Genetic S.p.A.

Contact name

Rocco Carmelo Pavese

Public contact point

Organisation

Genetic S.p.A.

Contact name

Rocco Carmelo Pavese

Third parties 1

Locations

1 EU/EEA country · 8 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 19 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications