A study of tacrolimus lipid suspension in adult patients of allergic conjunctivitis

Phase 2

Not yet recruiting

Conditions: Chronic conjunctivitis,

Registration Number: CTRI/2021/05/033314

Lead Sponsor: Intas Pharmaceuticals Ltd

Brief Summary: This is an open-label, single-arm clinical study to evaluate efficacy, safety and tolerability of tacrolimus lipid suspension for ophthalmic drops in adult patients of allergic conjunctivitis refractory to standard treatment.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 36

Inclusion Criteria

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.
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.
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.
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.
11.Patients with malignant tumors either as a concomitant disease or a history.
(Patients in whom malignant tumors had not recurred more than for 10 years are eligible).
12.Patients with systemic infectious disease.
13.Patients who are receiving treatment requiring hospitalization.
14.History of chemical substance abuse.
15.Patients with repeated anti-inflammatory drug treatment 16.Any condition which the study physician judges to preclude safe participation in the study or to confound the evaluation of the study outcome.
17.Patients who had participated in any other clinical or post-marketing studies (not only for study drugs but also for medical devices) before 60 days from the day of screening.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement (in the form of mean percentage change) from baseline in redness score (using the 4-point standardized rating scale) and itching score (using the 5-point standardized rating scale) at week 4 in each affected eye	At week 4

Secondary Outcome Measures

Name	Time	Method
- Improvement from baseline in allergic conjunctivitis as per physician s and patient s evaluation of global efficacy at week 4 in each affected eye.	- Improvement in total scoring of ocular signs and symptoms at week 4 against baseline in each affected eye.

Trial Locations

Locations (7): Divyajyoti Trust Tejas Eye Hospital
🇮🇳
Surat, GUJARAT, India
Dr. Shroff s Charity Eye Hospital
🇮🇳
Delhi, DELHI, India
GMERS Medical College and Civil Hospital
🇮🇳
Ahmadabad, GUJARAT, India
LV Prasad Eye Institute
🇮🇳
Hyderabad, TELANGANA, India
Occura Eye Care and Research Center
🇮🇳
Ahmadabad, GUJARAT, India
Sanjivani Super Speciality Hospital
🇮🇳
Ahmadabad, GUJARAT, India
Sarakshi Netralaya
🇮🇳
Nagpur, MAHARASHTRA, India
Divyajyoti Trust Tejas Eye Hospital
🇮🇳Surat, GUJARAT, India
Dr Uday Gajiwala
Principal investigator
9979461646
divyajyoti.icare@gmail.com