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Study to Compare the Efficacy and Safety of Two Non-Preserved Artificial Tears for the Treatment of Dry Eye Signs and Symptoms

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Allergan

Status and phase

Completed
Phase 4

Conditions

Dry Eye Syndromes

Treatments

Drug: sodium hyaluronate 0.18%
Drug: carboxymethylcellulose 0.5% +glycerin 0.9%

Study type

Interventional

Funder types

Industry

Identifiers

NCT00938704
MA-OPT-09-002

Details and patient eligibility

About

To compare the efficacy and safety of two non-preserved artificial tears, (carboxymethylcellulose 0.5%, + glycerin 0.9% vs. sodium hyaluronate 0.18%) eye drops for the treatment of the signs and symptoms of dry eye disease.

Enrollment

71 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Current use of an artificial tear product at least 2 times per day (e.g. for relief of dry eye symptoms of dryness).
  • Be likely to complete the entire course of study and to comply with appropriate instructions

Exclusion criteria

  • Have undergone refractive surgery (e.g., cataract surgery, PRK, LASIK, or any surgery involving a limbal or corneal incision) within the last 12 months.
  • Have uncontrolled systemic disease
  • Are currently using, or have used within 14 days of study enrollment, any ocular medications other than artificial tears
  • Have anticipated contact lens wear during the study
  • Have an active ocular infection

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

71 participants in 2 patient groups

1
Active Comparator group
Description:
carboxymethylcellulose 0.5%, glycerin 0.9%
Treatment:
Drug: carboxymethylcellulose 0.5% +glycerin 0.9%
2
Active Comparator group
Description:
sodium hyaluronate 0.18%
Treatment:
Drug: sodium hyaluronate 0.18%

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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