Comparing cyclosporin 0.05% with cyclosporin 0.09% in moderate to severe dry eye disease

Comparison of cyclosporin 0.05% versus cyclosporin 0.09% in moderate to severe dry eye disease - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/08/056025

Enrollment

332

Registered

2023-08-02

Start date

Unknown

Completion date

Unknown

Last updated

2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H041- Other disorders of lacrimal gland

Interventions

Intervention1: cyclosporin 0.05%: Route of administration- topical drops Dosage is twice a day for 3 months Control Intervention1: cyclosporin 0.09%: Route of administration- topical drops Dosage is

Eligibility

Inclusion criteria

Inclusion criteria: 1.Written informed consent. 2.Age more than 18 years at first visit 3.Have a best corrected visual acuity (BCVA) in both eyes of +0.7 logMAR 4.Diagnosis of DED in both eyes supported by the criteria mentioned below Defined by at least one eye meeting all the following criteria: i. A symptom severity score of >=22 for OSDI ii.An unanesthetized Schirmer Tear Test (STT) score of >=1 mm and iii.Evidence of ocular surface staining (total fluorescein staining score of at least 3) [0-15 scale]) 5. Have normal lid anatomy and no other ocular disease except refractive errors or cataract If both eyes match the criteria, then eye with less Schirmer value would be chosen for statistical analysis

Exclusion criteria

Exclusion criteria: 1) Presence of corneal epithelial defects/infection 2) Schirmer value of zero mm 3) Any ocular surgery within past 3 months 4) Any keratoplasty or ocular surface procedure performed during the trial 5) Any known hypersensitivity or contraindication to study treatments (including excipients), topical anesthetics or vital dyes. 6) Have used RestasisÂ® (cyclosporine ophthalmic emulsion) or Cequa within 30 days prior to Visit 1. 7) Clinically significant systemic disease (e.g., uncontrolled diabetes, hepatic, renal, endocrine or cardiovascular disorders)

Design outcomes

Primary

Measure	Time frame
Mean change from baseline in total corneal stainingTimepoint: 4 & 12 weeks	—

Secondary

Measure	Time frame
Mean change from baseline in the score of dry eye questionnaires, change in Schirmer values & NIBUT, degree of burning or stinging sensationTimepoint: 4 & 12 weeks	—

Countries

India

Contacts

Public ContactDr Swati Singh

L V Prasad Eye Institute

swatisingh@lvpei.org7036981646

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026