Health Condition 1: null- Dry Eye
Conditions
Interventions
Intervention1: Polyethylene Glycol- 0.4%, Propylene Glycol- 0.3%: 1 drop, 4 times (QID) per day for 90 days
Control Intervention1: NIL: NIL
Sponsors
Alcon laboratories India pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects must give informed consent, and be willing and able to attend all study visits 2. Adults aged >=18 yrs and 3. Best-corrected visual acuity (BCVA) of >= 55 letters in each eye as measured by ETDRS (letters read method) 4. Dry eye in both eyes diagnosed by an ophthalmologist 5. Tear film break-up time (TFBUT) eyes 6. Corneal staining score >= 3 (15-point NEI scoring system) 7. Unanesthetized Schirmer I score of >= 3 mm 8. Ocular Surface Disease Index (OSDI) >= 18
Exclusion criteria
Exclusion criteria: 1. Women of childbearing potential (those who are not surgically sterilized or postmenopausal for at least 2 years)are excluded from participating in the study if they meet any of the following conditions: a. They are currently pregnant, or b. They have a positive result on a pregnancy test at the Screening Visit, or c. They are breast feeding 2. Subjects demonstrating any medical condition (systemic or ophthalmic) that may, in the opinion of the Investigator and based on the content of the Investigatorâ??s Brochure, preclude the safe administration of test article or safe participation in the study 3. Any contraindications or hypersensitivities to the use of the study medications or their components 4. Evidence of the following within 30 days prior to the Screening Visit: • Ocular infection (bacterial, viral, or fungal) • Ocular inflammation including, but not limited to: - Inflammation of the anterior or posterior segments - Active allergic conjunctivitis - Active blepharitis or ocular rosacea 5. Any history of: • Trachoma • Stevens-Johnson Syndrome • Ocular herpes simplex or herpes zoster 6. Corneal conditions, other than dry eye related corneal epitheliopathies, affecting the corneal structure including but not limited to: • 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 best-corrected visual acuity. Any actively changing or unstable corneal condition; any cornealscar[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. • Keratoconus 7. Ocular surgery (of any type, including PRK, LASIK,Epilasik, etc.) or ocular trauma requiring medical or pharmacological treatment within 1 year of Screening 8. Current presence of punctal plugs (permanent or temporary)or permanent punctal closure by cautery/diathermy are excluded. Subjects with a history of punctal plug placement must be free of punctal occlusion for at least 30 days prior to Screening 9. Any corneal transplant procedure including penetrating keratoplasty, Descemetâ??s stripping endothelial keratoplasty (DSEK), or its variants 10. Suspected or definite lagophthalmos or history of Bellâ??s palsy (or other CN 7 palsy) or any other lid function abnormality (eg, entropion, ectropion, floppy eyelid syndrome, trichiasis, etc.) 11. Use of any of the following within 14 days of Screening: • Topical ocular prescription or non-prescription medications, • RESTASIS or topical ocular steroids 12. Use of any artificial tears/gels/lubricants/rewetting drops within 4 hours of Screening 13. Chronic medications (over the counter, prescription, or vitamins) that have not been on a stable dose for at least 30 days prior to Screening, or chronic medications that have been stopped within 30 days prior to Screening. Any anticipated <br/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary statistical efficacy objective of this study is to evaluate the efficacy of Systane Gel Drops in dry eye subjects following 90 days of QID dosing among Indian subjects with dry eye. The primary endpoint is change from Baseline in corneal staining score at all study time points. The corneal staining score will be assessed at Screening (Day 0), Visit 1 (Day 45),and Visit 2 (Day 90). Safety: â?¢ Adverse events â?¢ Extent of ExposureTimepoint: Screening visit day 0, day45 and day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| There is no secondary outcomeTimepoint: There is no secondary outcome, hence no Time points. | — |
Countries
India
Contacts
Public ContactDr Salman Anzer
Alcon Laboratories Pvt Ltd (India)
Outcome results
None listed