This study compares the effectiveness and safety of the study product cylclosporin against Restasis in patients suffering from moderate to severe dry eye.
- Conditions
- Keratoconjunctivitis,
- Registration Number
- CTRI/2019/03/018319
- Lead Sponsor
- New India Bio Pharma Pvt Ltd
- Brief Summary
The study is a phase IVcontrolled clinical trial, multi centre, randomized, open label, three-arm parallel group activecontrol study in subjects with moderate to severe Keratoconjunctivitis sicca(dry eye disease) in Indian clinical practice setting. The present study hasbeen designed to compare the efficacy and safety of topical formulation ofCYCLOSPORINE (0.05%, instilled as twice a day dose in each eye) andCYCLOSPORINE (0.05%, instilled as twice a day dose in each eye for one monthand once a day dose in each eye for rest five months) against the US FDAapproved and commercially available, topical preparation, RESTASIS® (AllerganIndia., Pvt. Ltd. instilled as twice a day dose in each eye) by objective andsubjective evaluations of tear production, ocular surface integrity, andsubject symptoms. Approximately 300 Eyes of subjects diagnosed for moderate tosevere dry eye disease and meeting the eligibility criteria, will be randomized(50 subjects in each arm) from approximately 6-8 participating investigatorssites across India.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 150
- 1.Male or female, between 18 and 65 years of age (both age inclusive).
- 2.Subjects presenting with documented signs and symptoms of moderate to severe Keratoconjunctivitis sicca (KCS) by diagnostic criteria as per investigators discretion.
- 3.History of KCS for a period of at least 6 months 4.Lack of clinically adequate improvement despite conventional management, which may have included artificial tear eye drops, topical parasympathomimetic agent’s topical steroids in the affected eye(s).
- Schirmer Tear Test (ST) score (without anesthesia) ≤ 10 mm/5 min in at least one eye.
- Positive corneal staining, defined as a corneal fluorescein staining (CFS) score of greater or equal to 4 in either eye by the National Eye Institute (NEI) /Industry Workshop Evaluation scale summed over 5 areas each with a 0-3 scoring scale,where 0 equals to normal,and 3 equals to severe with a maximum total score of 15.
- 7.Positive conjunctival staining, defined as a conjunctival lissamine green staining (CLGS) score of greater or equal to 4 in either eye by the National Eye Institute (NEI) /Industry Workshop Evaluation scale summed over 3 areas each with a 0-3 scoring scale, where 0 equals to normal and 3 equals to severe with a maximum total score of 18.
- At least one of the following ocular symptoms scored at ≥2, where a.
- 0 equals none and 4 equals to very severe/interferes with normal activities- photophobia, blurred vision, foreign body sensation, soreness or pain, itching, burning, dryness.
- 9.Ocular Surface Disease Index (OSDI) ≥20;) 10.Best corrected visual acuity (BCVA) of 0.7 log MAR or better in each eye as assessed using an ETDRS chart 11.Normal lid position and closure.
- 1.Present or history (in the preceding 6 months) of any systemic or ocular condition(s) that could possibly interfere with the interpretation of the study results; 2.Any disease of the eye leading to diffuse loss of conjunctiva; 3.Active anterior blepharitis; 4.A history or current evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccine, active or recent varicella viral disease of the cornea and/or conjunctiva; ocular rosacea; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye; 5.Current infections of the anterior segment or uveitis; 6.Uncontrolled systemic disease or the presence of any significant illness that can, in the judgment of the Investigator, interfere with interpretation of the study results; 7.Recent use (within 1 month) or anticipated use of temporary punctual plugs during the study; 8.Permanent occlusion of lacrimal puncta within 3 months of the study; 9.Subjects unwilling to discontinue contact lens wear at least one week prior to screening/ baseline visit and during the study duration; 10.
- Use of RESTASIS® (cyclosporine ophthalmic emulsion, 0.05%) or any other topical and/or systemic cyclosporine within 90 days before the study.
- 11.Previous treatment failure (lack of efficacy) with cyclosporine ophthalmic emulsion 0.05%.
- Diagnosis of Sjogren’s disease ˃ 5 years prior to the Screening Visit.
- 14.Use of systemic or topical medications within 7 days prior to the Screening Visit or during the study period that are known to cause dry eye.
- Corneal transplant.
- Corneal refractive surgery within 6 months prior to the Screening Visit or postoperative refractive surgery symptoms of dryness that have not resolved; 17.Lasik surgery done within 6 months prior to screening visit.
- 18.Cataract surgery within 3 months prior to the screening visit.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in Corneal Staining Scores 3 months and 6 months of treatment from baseline
- Secondary Outcome Measures
Name Time Method Mean change in Schirmer Tear Test scores (without anaesthesia) 1, 2, 3, and 6 months from Global evaluation of overall effect of study medication 3 month and 6month from baseline Clinically significant changes in the ocular examination 6 Months Mean change in Corneal Staining Scores 1, 2, 3, and 6 months of treatment from baseline Mean change in Conjunctival Staining Scores 1, 2, 3, and 6 months of treatment from baseline Mean change in Ocular Surface Disease Index Score (OSDI) scores 1, 2, 3, and 6 months from Mean change in symptom scores 1, 2, 3, and 6 months of treatment from baseline
Trial Locations
- Locations (7)
Centre for Sight Eye Institute
🇮🇳Delhi, DELHI, India
Christian Medical College & Hospital
🇮🇳Ludhiana, PUNJAB, India
Dr Shroff Charity Eye Hospital
🇮🇳Delhi, DELHI, India
Dr.R.P.Centre for Ophthalmic Sciences,
🇮🇳South, DELHI, India
L V Prasad Eye Institute
🇮🇳Hyderabad, TELANGANA, India
Post Graduate Institute of Medical Sciences & Research
🇮🇳Chandigarh, CHANDIGARH, India
Rajiv Gandhi Institute of Medical Sciences & RIMS Govt. General Hospital
🇮🇳Srikakulam, ANDHRA PRADESH, India
Centre for Sight Eye Institute🇮🇳Delhi, DELHI, IndiaDr Tulika ChauhanPrincipal investigator9535133800toolika.chauhan@gmail.com