Evaluation of the Effect and Tolerance of Preservative Free NAAGA on the Inflammatory Component and Symptoms of Dry Eye Syndrome in Allergic Conjunctivitis Patients

Thea Pharma

Status and phase: Completed; Phase 4

Conditions: Allergic Conjunctivitis

Treatments: Drug: NAABAK eyedrops; Drug: Saline eyedrops

Study type: Interventional

Funder types: Industry

Identifiers

NCT01203540

LT0455-IST-01/10

NBKE_SNUBH&BM_01

Details and patient eligibility

About

Multicentre, Double blind, Randomized, Comparative Study(comparing N-acetyl-aspartyl-glutamic acid(NAAGA) in Abak preservative free device versus SALINE in Abak preservative free device.

Evaluation of the effects and safety of NAABAK® through inflammation markers and symptoms in patients with allergic conjunctivitis and dry eye syndrome after 3 months treatment.

The patients will attend 4 visits.

Enrollment: 21 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 20 years old
• Patients with dry eye syndrome in allergic conjunctivitis

Exclusion criteria

• Severe dry eye syndrome
• Severe ocular pathology

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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21 participants in 2 patient groups, including a placebo group

Naaga in ABAK system

Experimental group

Treatment:

Drug: NAABAK eyedrops

Saline solution

Placebo Comparator group

Treatment:

Drug: Saline eyedrops