Eye drops in Indian Subjects to treat dry eye

Phase 4

• Conditions: Health Condition 1: H049- Disorder of lacrimal system, unspecified

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 3 April 2023

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 177

Inclusion Criteria

1. 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 investigatorâ??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

1. 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.

b. 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, Descemetâ??s stripping endothelial keratoplasty, or its variants;

9. Suspected or definite lagophthalmos or history of Bellâ??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

Study & Design

• Study Type: PMS
• Study Design: Not specified