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Comparative efficacy and safety of preserved and preservative-free anti-glaucoma therapy

TO COMPARE THE EFFECT OF BENZALKONIUM CHLORIDE-PRESERVED LATANOPROST AND BENZALKONIUM CHLORIDE-FREE LATANOPROST ON OCULAR SURFACE HEALTH IN PATIENTS OF PRIMARY OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/06/007001
Enrollment
30
Registered
2016-06-06
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Already diagnosed cases of primary open angle glaucoma or ocular hypertension

Interventions

Intervention1: Benzalkonium -chloride(BKC) preserved latanoprost: Established cases of POAG or ocular hypertension with IOP controlled on monotherapy of BKC-preserved latanoprost for more than three

Sponsors

Government Medical College Patiala
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Established cases of POAG or ocular hypertension with IOP controlled on monotherapy of BKC-preserved latanoprost for more than three months.

Exclusion criteria

Exclusion criteria: 1 Known lack of ocular hypotensive response to topical ophthalmic, prostaglandin analogs (in the opinion of the investigator). 2 Intraocular conventional surgery or laser surgery within the past one year. 3 Any refractive surgery in study eye . 4 Patients on steroids medication. 5 Ocular trauma within the past 3 months. 6 Patients suffering from Rheumatoid arthritis or any other systemic disease which also causes dry eye. 7 Patients taking any other medication which also causes dry eye. 8 Progressive retinal or optic nerve disease apart from glaucoma. 9 Concurrent infectious/non infectious conjunctivitis, keratitis, or uveitis in either eye. 10 Any abnormality preventing stable applanation tonometry. 11 Use of contact lens for the duration of the study. 12 Any opacity or subject uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber. 13 Clinically significant ocular disease (e.g., corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study,. 14 Clinically significant systemic disease which might interfere with the study. 15 History of non-compliance to medical regimens or unwilling to comply with the study protocol. 16 Patients with hypersensitivity or poor tolerance to any components of the study medication. 17 Angle closure glaucoma or a history of acute angle closure treated with a peripheral iridotomy. 18 Participation in another clinical study within the last thirty (30) days.

Design outcomes

Primary

MeasureTime frame
Reduction in OSDI score,normal readings of schirmer test and tear film break up time in patients of POAG/ Ocular hypertensionTimepoint: Baseline (0), 6 and 12 weeks

Secondary

MeasureTime frame
Reduction in Intraocular pressure (IOP)Timepoint: Baseline (0), 6 and 12 weeks

Countries

India

Contacts

Public ContactDr Hema Chhabra

Government Medical College Patiala

drguptaanita@hotmail.com9872139567

Outcome results

None listed

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