A new drug as an adjunct therapy for patients of dry eye disease

Adjunct therapy with topical Recombinant DNA Polymerase in Dry eye disease - NIL

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/065924

Enrollment

Registered

2024-04-18

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Health Condition 1: H048- Other disorders of lacrimal system

Interventions

Intervention1: Recombinant DNA Poylmerase: 0.02% topical recombinant DNA polymerase will be used 4 times a day for 12 weeks along side standard dry eye disease therapy Control Intervention1: Standard

Eligibility

Inclusion criteria

Inclusion criteria: Patients more than 18 years of age with moderate to severe dry eye disease Tear film breakup time less than or equal to seven seconds Schirmers test less than or equal to 10mm for 5 min OSDI Score more than equal to 13

Exclusion criteria

Exclusion criteria: Patients not consenting to follow up Presence of active systemic or ocular infection Allergic to any topical eye drops Use of contact lens within last two weeks Pregnant or lactating Associated ocular inflammatory conditions Any cognitive or psychiatric deficit that precludes consent or ability to perform Hace active drug or alcohol dependance

Design outcomes

Primary

Measure	Time frame
Scores of ocular surface evaluation tests such as OSDI Score, TFOSE DEWS 2 Score, TBUT, NEI conjunctival and corneal staining score, Schirmers test, Conjunctival hyeremia score, Mucid strands score Changes in meibomian gland and tear imaging as LIPIVIEW for Lipid layer thickness, Tear meniscus height, Non invasive tear breakup time and mebomian gland lossTimepoint: At baseline, 2 weeks, 1 month, 3 months and 6 months	—

Measure

Time frame

Scores of ocular surface evaluation tests such as OSDI Score, TFOSE DEWS 2 Score, TBUT, NEI conjunctival and corneal staining score, Schirmers test, Conjunctival hyeremia score, Mucid strands score Changes in meibomian gland and tear imaging as LIPIVIEW for Lipid layer thickness, Tear meniscus height, Non invasive tear breakup time and mebomian gland lossTimepoint: At baseline, 2 weeks, 1 month, 3 months and 6 months

—

Secondary

Measure	Time frame
Visual acuity assessment Tolerability to eye drops Drug adherence using treatment grading scaleTimepoint: At baseline 2weeks 1 month 3 months 6 months	—

Countries

India

Contacts

Public ContactKhatheeja Salwa

ALL INDIA INSTITUTE OF MEDICAL SCIENCES

khatheejasalwa29@gmail.com9686280369

Outcome results

None listed

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