Eye drops in Indian Subjects to treat dry eye

Phase 4

Active, not recruiting

• Conditions: Disorder of lacrimal system, unspecified,

• Registration Number: CTRI/2022/03/041175
• Lead Sponsor: Alcon Research Ltd

Brief Summary

This is a 3-month, open label, prospective, single-arm, multicenter, Phase IV clinical study to evaluate the safety profile and efficacy of SYSTANE(TM) HYDRATION ophthalmic lubricant drops in Indian subjects with dry eye disease. The study will be conducted up to 5 sites in India, and will include approximately 177 subjects aged between 18-65 years to have 150 evaluable subjects.

All study procedures will begin after obtaining written informed consent from the subjects. Subjects will be expected to attend scheduled study visits at Day 1 (Screening and Baseline), and Day 90±5 days (End of Study [EOS]). Telephonic follow-up on Day 30 (±5 days) and Day 75 (±5 days).

All eligible subjects will be dispensed with IP bottles (SYSTANETM HYDRATION Lubricant Eye Drops) sufficient for 90 days’ use at Day 1 and will be instructed to self-administer 1 or 2 drops of IP four times daily in each eye. The first administration of IP will take place at the study site and will be done by the Investigator/qualified study personnel.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-04
• Last Update Posted: 2023-10-03

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 177

Inclusion Criteria

• Male or female adults aged >18 years and <65 years of age; 2.
• Subject must be willing to participate in the study and should understand and sign an informed consent form (ICF) that has been approved by Institutional Review Board (IRB)/ Institutional Ethics Committee (IEC); 3.
• BCVA of ≥20/40 in each eye as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart; 4.
• DEQ-5 score ≥6; 5.
• TBUT ≤10 seconds in both eyes; 6.
• Average TOSS score ≥4 (based on the 15-point Oxford grading scheme); 7.
• Subject is otherwise healthy and medically stable on the basis of medical history at screening (based on the investigator’s medical judgment); 8.
• Male and female subjects of childbearing potential willing to practice appropriate birth control methods during the entire duration of the study.
• Appropriate birth control methods include tubal ligation, transdermal contraceptive patch, intra uterine devices/systems, oral, implantable, or injectable contraceptives, sexual abstinence, double-barrier methods, and vasectomized partner.

Exclusion Criteria

• Women of childbearing potential (those who are not surgically sterilized or not postmenopausal for at least 1 year) are excluded from participating in the study if they meet any of the following conditions: a.
• They are currently pregnant or planning to be pregnant during the study, or b.
• They have a positive result on a urine pregnancy test (human chorionic gonadotropin) at the Screening Visit, or c.
• They are breast feeding; 2.
• Contraindications or hypersensitivities to any of the components of the study treatment; 3.
• Evidence of the following within 30 days prior to the Screening Visit: a.
• Ocular infection (bacterial, viral, or fungal) b.
• Ocular inflammation including, but not limited to: i.
• Inflammation of the anterior or posterior segments ii.
• Active allergic conjunctivitis iii.
• Active blepharitis or ocular rosacea; 4.
• Any history of: a.
• Trachoma b.
• Stevens-Johnson Syndrome c.
• Ocular herpes simplex or herpes zoster; 5.
• Corneal conditions, other than dry eye-related corneal epitheliopathies, affecting the corneal structure including but not limited to: a.
• Clinically significant epithelial or endothelial corneal dystrophies.
• NOTE: Clinically significant corneal dystrophies are defined as those that affect the central corneal surface (central 5 mm zone) and are associated with the corneal erosion syndrome or central corneal epithelial microcystic edema which will adversely affect BCVA.
• Any actively changing or unstable corneal condition; any corneal scar[s] affecting corneal clarity or structure of the cornea or demonstrate an area[s] of concentrated corneal staining.
• Pterygia that extend >2 mm onto the corneal surface, or any ptyergia that are elevated rather than flat and/or demonstrating significant active inflammation c.
• Keratoconus; 6.
• Ocular surgery (of any type, including photorefractive keratectomy, laser-assisted in situ keratomileusis, epipolis laser in situ keratomileusis [Epilasik], etc.) or ocular trauma requiring medical or pharmacological treatment within 1 year of Screening; 7.
• Current presence of punctal plugs (permanent or temporary) or permanent punctal closure by cautery/diathermy are excluded except subjects who are free of punctual occlusion for at least 30 days prior to Screening; 8.
• Any corneal transplant procedure including penetrating keratoplasty, Descemet’s stripping endothelial keratoplasty, or its variants; 9.
• Suspected or definite lagophthalmos or history of Bell’s palsy (or other 7th cranial nerve [CN 7] palsy) or any other lid function abnormality (e.g., entropion, ectropion, floppy eyelid syndrome, trichiasis, etc.); 10.
• Use of any of topical ocular prescription or non-prescription medication, prior to 14 days of screening; 11.
• Systemic medications known to cause dry eye disease (such as anti-histamines, beta blockers, diuretics, anti-depressants, anti-psychotic medications, and benzodiazepines) which are newly started or stopped or whose dose has been changed 30 days prior to Screening; 12.
• Contact lens wear within 1 week of Screening and/or unwillingness to discontinue contact lens wear for the duration of the study; 13.
• Subjects with any prior history of artificial tears/gels/lubricants/rewetting drops use in last 6 weeks; 14.
• Participation in any other clinical study (device or drug) within 30 days prior to Screening; 15.
• Any other condition that in the Investigator’s judgment, might interfere with study assessments.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Treatment-emergent AEs	1. During the study | 2. baseline and at 90 days
2. TOSS score using Oxford grading scheme collected	1. During the study | 2. baseline and at 90 days

Secondary Outcome Measures

Name	Time	Method
Dry eye symptoms score will be summarized by using descriptive statistics	at 90 days

Trial Locations

Locations (5)

Bhagawan Mahavir Jain Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Dr. Shroff Charity Eye Hospital; 🇮🇳 Delhi, DELHI, India

Sankara Eye Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Sankara Nethralaya; 🇮🇳 Chennai, TAMIL NADU, India

The Eye Foundation; 🇮🇳 Coimbatore, TAMIL NADU, India

Bhagawan Mahavir Jain Hospital

🇮🇳Bangalore, KARNATAKA, India

Dr Rajesh Parekh

Principal investigator

09945544744

vision6by6@gmail.com