ClinicalTrials.Veeva

Menu

A Two Comparator, Controlled Phase 3 Study in Patients With and Without Evaporative Dry Eye

T

The University of New South Wales

Status and phase

Completed
Phase 3

Conditions

Dry Eye Syndromes

Treatments

Drug: Optive
Drug: Optive Advanced
Drug: Omega 3

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02871440
SOVS2016-040

Details and patient eligibility

About

Omega 3 (OM3) Tear is a new unit dose emulsion, containing flaxseed/castor oil, which is being developed by Allergan. It is desirable to understand the effect that this new emulsion has on tear film evaporation and tear lipid profile via interferometry, in patients with evaporative dry eye (EDE) and those without (non-EDE). It would also be valuable to evaluate the retention time of the lipid components of the new emulsion via tear collection and analysis in EDE and non-EDE patients

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent;
  • Over 18 years of age;
  • Not wearing contact lenses in the past 3 months before enrolling
  • Willing to use eye drops and comply with the study visit schedule as directed by the Investigator;
  • Habitual (corrected or uncorrected) visual acuity of 6/9.5 or better in each eye;
  • At the Screening visit (Day -14), patients must have Ocular Surface Disease Index (OSDI) score >18 (0 to 100 scale). At Baseline (Day 1) visits, patients must have OSDI score > 12 to continue in the study.
  • TBUT≤10sec in at least 1 eye at Screening visit and Baseline visit
  • Corneal sodium fluorescein staining score ≥ 1 and <4 (Oxford scheme) at Screening and Baseline visit.

Exclusion criteria

  • Schirmer test (with anesthesia) ≤ 2 mm in either eye at Screening
  • Patients who are currently using topical ocular medication or have used topical ocular medication within 2 weeks of the Screening visit. Patients who are being treated bilaterally with a marketed artificial tear for dry eye can be considered, provided they discontinue use at the Screening visit;
  • Any active anterior segment disease excluding blepharitis;
  • Any systemic disease that may affect ocular health e.g. Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis and systemic lupus erythematosus;
  • History of epilepsy or migraines exacerbated by flashing, strobe-like lights;
  • Rigid or soft contact lens wearer, including orthokeratology;
  • History of eye surgery within 6 months prior to enrolment in the study;
  • Previous corneal refractive surgery

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 3 patient groups

Eye drop 1
Experimental group
Description:
Omega 3
Treatment:
Drug: Omega 3
Eye drop 2
Active Comparator group
Description:
Optive Advanced
Treatment:
Drug: Optive Advanced
Eye drop 3
Active Comparator group
Description:
Optive
Treatment:
Drug: Optive

Trial documents
1

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems