TO study the Safety and efficacy of Cyclisis PF eye drop for treatment of Dry Eye Disease.

Safety profile and efficacy of Cyclisis PF, Preservative free Cyclosporine Ophthalmic Solution 0.05%, for treatment of Dry Eye Disease.

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/068159

Enrollment

Registered

2024-05-31

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

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 Health Condition 2: H048- Other disorders of lacrimal system

Interventions

Intervention1: Cyclisis PF: Cyclosporine 0.05% Intervention2: Cyclisis PF: Cyclosporine 0.05% Intervention3: Cyclisis PF: Cyclosporine 0.05% solution (CYclisis PF) will be administered as eye drop, tw

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects between 18-75 years of age of both genders 2. Subjects with known case of dry eye disease 3. Best Corrected Visual Acuity (BCVA) of 6/24 [Log MAR equivalent (0.6)] or better 4. Ocular Surface Disease Index (OSDI) = 18 5. Tear film break-up time (TBUT) = 10 seconds 6. Schirmer tear test (without anesthesia) = 10mm / 5min 7. Tear Meniscus Height 8. Corneal fluorescein staining score [as per National Eye Institute (NEI) scale] = 3 9. Conjunctival lissamine green staining score (as per NEI scale) =6 10. Normal lid position and closure 11. Willingness to sign written informed consent document

Exclusion criteria

Exclusion criteria: 1. Any ocular condition that, in the opinion of the Investigator, could affect study parameters. This includes, active ocular infection, ocular inflammation, ocular trauma, blepharitis or, any other condition as deemed by the Investigator. 2. Unwilling to refrain from contact lens use for the entire duration of this study. 3. Any significant illness that could interfere with study parameters. 4. History of any other ocular surgical procedure within 3 months. 5. Subject with known allergy or hypersensitivity to the components of the formulation.

Design outcomes

Primary

Measure	Time frame
1.The mean change in the Tear film break-up time (TBUT) 2.The mean change in the Ocular surface disease index score (OSDI)Timepoint: 1. The mean change in the Tear film break-up time (TBUT) at Week 2, Week 4 and Week 12. 2. The mean change in the Ocular surface disease index score (OSDI) at week 2, week 4 and week 12.	—

Secondary

Measure	Time frame
1. The mean change in the Schirmer Tear test (without anesthesia) 2. The mean change in the Corneal Fluorescein Staining score (CFS) 3. The mean change in the Conjunctival Lissamine Green Staining score 4. The mean change in the Tear Meniscus Height (TMH) 5. The mean change in lipid layer thickness (LLT) Timepoint: 1.The mean change in the Schirmer Tear test (without anesthesia) from baseline to Week-2, Week-4 and Week-12. 2.The mean change in the CFS from baseline to Week-2, Week-4 and Week-12. 3.The mean change in the Conjunctival Lissamine Green Staining score from baseline to Week-2, Week-4 and Week-12. 4.The mean change in the TMH from baseline to Week-2, Week-4 and Week-12. 5.The mean change in the LLT from baseline to Week-2, Week-4 and Week-12.	—

Measure

Time frame

1. The mean change in the Schirmer Tear test (without anesthesia) 2. The mean change in the Corneal Fluorescein Staining score (CFS) 3. The mean change in the Conjunctival Lissamine Green Staining score 4. The mean change in the Tear Meniscus Height (TMH) 5. The mean change in lipid layer thickness (LLT) Timepoint: 1.The mean change in the Schirmer Tear test (without anesthesia) from baseline to Week-2, Week-4 and Week-12. 2.The mean change in the CFS from baseline to Week-2, Week-4 and Week-12. 3.The mean change in the Conjunctival Lissamine Green Staining score from baseline to Week-2, Week-4 and Week-12. 4.The mean change in the TMH from baseline to Week-2, Week-4 and Week-12. 5.The mean change in the LLT from baseline to Week-2, Week-4 and Week-12.

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Countries

India

Contacts

Public ContactDr Namrata Sharma

All India Institute of Medical Sciences

namrata.sharma@gmail.com011-26593144

Outcome results

None listed

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