Health Condition 1: H578- Other specified disorders of eye and adnexa
Conditions
Interventions
Intervention1: Carboxymethylcellulose Sodium IP and Glycerin IP (0.5% w/v + 1% w/v): Route: Ophthalmic
Frequency & Method of Administration: Instill 1 or 2 drops in the affected eye(s) as needed.
Con
Sponsors
Sun Pharmaceutical Industries Limited (SPIL)
Sun Pharma Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either gender with age between 18 to 65 years (both inclusive) and willing to provide written informed consent 2. Dry eye disease (DED) in both eyes diagnosed by an Ophthalmologist at screening 3. Patients with history of use of artificial tears within 30 days before the screening visit and who didn t respond to the previous dry eye treatment 4. Women of childbearing potential must have a negative urine pregnancy test at screening visit and randomization visit and agree to use highly effective methods of contraception to prevent pregnancy from study entry till end of study (such contraception may include hormonal birth control e.g. combined oestrogen and progestogen containing [oral, intravaginal or transdermal] or progesterone only [oral, injectable or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or sexual abstinence). [Note: Women with childbearing potential are defined as: those who are not (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) postmenopausal. Postmenopausal woman will be defined as: Woman not using hormonal replacement therapy and have had at least 12 continuous months of natural (spontaneous) amenorrhoea and be greater than 45 years of age]. 5. Male patients must have had a successful vasectomy (confirmed azoospermia) or they and their female partners should be practicing highly effective contraception throughout the study period. (Contraception by female partner is not required if she is not a woman of childbearing potential) [No sperm donation is allowed during the study period] a subjects with sjogren s disease, rheumatoid arthritis, or thyroid disease are eligible for randomization provided they met all inclusion criteria
Exclusion criteria
Exclusion criteria: 1. Severe Corneal or conjunctival staining 2. Ocular/ophthalmic surgery or trauma, which could affect corneal sensitivity and/or tear distribution within 6 months prior to screening, 3. Patients who have ocular disease other than dry eye disease at screening which might affect the assessment of dry eye severity and efficacy of study medications 4. Active ocular infection, inflammation, allergy, or blepharitis 5. Any ocular condition that, in the opinion of the Investigator, could affect study parameters 6. Use of any systemic medication that may affect tear film or vision, within 1 month prior to screening or a change in dosage anticipated during the study 7. Use of prohibited medications (topical or systemic) during the appropriate pre-study washout period and during the study. 8. Patients with history of any clinically significant medical and/or psychological condition or laboratory abnormalities that, in the opinion of the Investigator would jeopardize the safety of the patient or affect the validity of the study results 9. History of hypersensitivity to the study medication or any of its components 10. Patients with history of positive result of human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) at screening visit 11. Patients with history of malignancy in the last 5 years prior to Screening or undergoing cancer chemo or radiotherapy 12. Patients who have participated in another Investigational study within the 3 months prior to Screening 13. Patients with known alcohol or other substance abuse within last one year prior to screening and should avoid alcohol during the study 14. Employee of the Sponsor, Investigator, or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members of the employees of Sponsor or the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving 30% or more reduction from baseline in EDS-VAS scoreTimepoint: Baseline, Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving 30% or more reduction from baseline in EDS-VAS scoreTimepoint: Baseline, Day 28, Day 56;Change from baseline in EDS-VAS scoreTimepoint: Baseline, Day 28, Day 56, Day 84;Change from baseline in SPEED scoreTimepoint: Baseline, Day 28, Day 56, Day 84;Change from baseline in tear film break-up time (TBUT) assessed during the 2 minutes waiting period for corneal staining Timepoint: Baseline, Day 28, Day 56, Day 84;Change from baseline in tear film height (TFH)Timepoint: Baseline, Day 84;Change from baseline in corneal fluorescein staining scoreTimepoint: Baseline, Day 28, Day 56, Day 84;Change from baseline in conjunctival lissamine green staining scoreTimepoint: Baseline, Day 28, Day 56, Day 84;Change from baseline in Schirmer s test (Unanesthetized)Timepoint: Baseline, Day 28, Day 56, Day 84;Incidence and severity of ocular adverse eventsTimepoint: Throughout the study period;Incidence and severity of non-ocular adverse eventsTimepoint: Throughout the study period | — |
Countries
India
Contacts
Public ContactVidya Sethumadhavan
Sun Pharma Laboratories Limited
Outcome results
None listed