CTRI/2021/05/033314
Not yet recruiting
Phase 2
An open-label, single-arm clinical study to evaluateefficacy, safety and tolerability of tacrolimus lipid suspension for ophthalmic drops in adult patients of allergic conjunctivitis refractory to standard treatment
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: H104- Chronic conjunctivitis
- Sponsor
- Intas Pharmaceuticals Ltd
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Clinical diagnosis of bilateral allergic conjunctivitis (AC) made by an experienced ophthalmologist following recording of symptoms based on complete ophthalmic examination as per standard clinical practice using determination of visual acuity, slit\-lamp biomicroscopy and indirect ophthalmoscopy, whenever required.
- •2\. Not responsive to treatment with first line therapeutic agents for sufficient duration as per the best discretion of the Investigator which must include cold compress, artificial tears, topical over the counter preparations, anti\-histaminics, mast cell stabilizers and / or topical corticosteroids depending upon the severity of disease
- •3\. Female subjects of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test at the start of treatment.
- •4\. Surgically sterile, post\-menopausal, or sexually abstinent patient or partner must agree to use a medically appropriate form of birth control from screening until 14 \+ 2 day after the last dose of study medication.
- •5\. The patients who are able to understand and sign a written informed consent form, which is obtained prior to initiation of study procedures.
Exclusion Criteria
- •1\.Presence of co\-existing ocular diseases such as glaucoma, dry eye syndrome, uveitis, ocular infection.
- •2\.Presence of systemic diseases other than co\-existing allergic rhinitis, asthma and atopic dermatitis.
- •3\.Patient with ocular structural abnormalities like lid scarring, entropion, trichiasis, etc.
- •4\.Reported hypersensitivity to Tacrolimus or cyclosporine or have a history of serious AEs related to their use.
- •5\.Patients wearing contact lenses.
- •6\.Patients who could not discontinue receiving ocular vasoconstrictor and ocular nonsteroidal anti\-inflammatory drugs at the start of study drug administration.
- •7\.Patients who underwent cryosurgery or surgical excision of giant papillae of the eye(s) to which the study drug was to be instilled within 4 weeks prior to the start of study drug administration.
- •8\.Patients who were receiving desensitization therapy or immune modulation therapy in any form 4 weeks prior to the start of study drug administration.
- •9\.Patients who had cataract as a complication in the eye(s) to which the study drug was/were to be instilled, making it impossible to perform fundoscopy by mydriasis.
- •10\.Expecting mothers, lactating mothers, or women wishing to become pregnant.
Outcomes
Primary Outcomes
Not specified
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