Prospective clinical trial to evaluate efficacy, safety and usability of nanoemulsion cyclosporin 0.05%, emulsion cyclosporin 0.05% and diquafosol 3% in dry eye patients

Not Applicable

Completed

• Conditions: Diseases of the eye and adnexa

• Registration Number: KCT0002180
• Lead Sponsor: The Catholic University of Korea, Yeouido St. Mary's Hospital

Brief Summary

Primary endpoints showed statistically significant improvements in all groups. Primary endpoints were -6.60 for the CN group, -5.28 for the CE group, and -6.63 for the DQ group (National Eye Institute scale from 0 to 33), verifying the non-inferiority of CN compared to CE (95% confidence interval, -0.15 to 2.80, ?>-2.88). In intergroup comparison between CN and CE groups, the CN group had significantly more decreased conjunctival staining score at week 12. Intergroup comparison between CN and DQ groups showed consistent statistically significant improvements in TBUT and Schirmer test in the CN group. In the DQ group, TBUT showed late statistically significant improvement at week 12 and Schirmer test showed relatively short-term statistically significant improvement at week 4. Conclusions: Cyclosporine nanoemulsion 0.05% was equivalently efficient compared to cyclosporine emulsion 0.05% and diquafosol sodium 3%. In addition, CN showed significant improvements in several parameters for treatment of dry eyes.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 227

Inclusion Criteria

1) =19 years of age
2) moderate to severe Dry eye syndrome (Corneal BFS score(NEI scale) = 4 and = 10 sec on TBUT)
3) volentary agreement with signed informed consent

Exclusion Criteria

1. cyclosporine or diquafosol use in any form(systemic, topical) within 4 weeks
2. medical condition or history within 4 weeks to be treated with topical agents besides artifical tears(glaucoma, ocular allergy, ocular inflammation/infectious disease, etc)
3. new start or medication change within 4 weeks for systemic drugs with probable effect on dry eye codition
4. sjogren syndrome
5. plan to wear contact lens during the study period
6. current or history of ocular disorders possibly affecting the study results(ocular surgery, trauma, diseases)
1) entropion, blepharelosis, blepharoplegia
2) ocular surgery history within 4 weeks or plan during the study period like punctal plug, punctal closure etc
3) herpetics keratopathy, conjunctival scarring by cicatricial keratoconjunctivitis, pterygium, congenital lacrimal gland shortage, neurogenic keratitis, keratoconus, corneal transplantation
7. known hypersensitivity to study medications
8, pregnancy or lactation
9. investigator's judge of inappropiation

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in corneal conjunctival staining score

Secondary Outcome Measures

Name	Time	Method
Changes in corneal conjunctival staining score ;Changes in corneal staining score;Changes in conjunctival staining score;Changes in TBUT (tear break-up time);Changes in schirmer I test score ;Changes in OSDI(ocular surface disease index);Patient global evalution;tear mucin level change [exploratory endpoint];tear cytokine level change [exploratory endpoint]