A clinical Trial in patients suffering from severe dry eye symptoms associated with syndromes related to excess mucous production. Clinical trial is to study effect, safety and tolerability of Acetylcysteine Eye Drops in comparison to Ilube Eye Drops (reference product).

A comparative, single blind, parallel group, non-crossover, multi-centric clinical trial of Acetylcysteine Eye Drops, with Ilube Eye Drops (Acetylcysteine Eye Drops), in patients suffering from severe dry eye symptoms associated with syndromes related to excess mucous production.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000677

Enrollment

200

Registered

2009-10-15

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: H044- Chronic inflammation of lacrimal passages Health Condition 2: null- Dry eye symptoms associated with syndromes related to excess mucous production

Interventions

Intervention1: Acetylcysteine Eye Drops: one - two drop in each affected eye three times per day for 2 weeks Control Intervention1: Ilube Eye Drops (Acetylcysteine Eye Drops): one - two drop in each a

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male and Female patients of age 18 years and older. 2.Patient with history, signs & symptoms of severe dry eye symptoms associated with syndromes related to excess mucous production. 3.Availability of subjects for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.

Exclusion criteria

Exclusion criteria: a. Patients with age group <18 & >60 years. b. History of hypersensitivity to the study drug or related products. c. Significant history or presence of gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of common medications. d. Pregnant or lactating women. e. Any clinical significant illness during the 4 weeks prior to day 1 of this study. f. Maintenance therapy with any drug, or history of drug dependency, alcohol abuse, or serious neurological or psychological disease. g. Participation in a clinical trial with an investigation drug within 30 days proceeding day 1 of this study. h. Use of enzyme-modifying drugs within 30 days prior to day 1 of this study. i. HIV and Australian Antigen positive subjects. j. Any condition that, in the opinion of the investigator, does not justify the patients inclusion in the study.

Design outcomes

Primary

Measure	Time frame
In patients suffering from severe dry eye symptoms associated with syndromes related to excess mucous production.Timepoint: Day 0, first week, Second week.	—

Secondary

Measure	Time frame
Pain in eye, Redness in eye, Itching of eye, Inflammation of eye and Sticky eye.Timepoint: Day 0, first week, Second week.	—

Countries

India

Contacts

Public ContactDr Shailesh Singh

Ajanta Pharma Ltd, Advent

shaileshs@ajantapharma.com022-66062112

Outcome results

None listed

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