Autologous Serum Efficacy Study in Patients With Severe Dry Eye

NCT00779987 | Completed Phase 2 DMC

• 1 other identifier: AP261
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the reduction in symptomatology of patients with severe dry eye treated with autologous serum and conventional artificial tears.

Conditions

Dry Eye

Keywords

Dry eye; Autologous serum; Ocular Surface Disease Index

Outcome Measures

Primary Outcomes (1)

• To compare the score reduction in the Ocular Surface Disease Index (OSDI) between patients treated with autologous serum and conventional artificial tears.

  5 weeks

Secondary Outcomes (1)

• To compare variations in objective eye measurements, such as Tear Break Up Time and corneal-conjunctival staining according to the Oxford Score, in patients treated with autologous serum and conventional artificial tears.

  5 weeks

Study Arms (2)

Autologous serum -Systane

OTHER

Crossover arm starting with autologous serum for 2 weeks. After a 1 week wash out with 0.9% sodium chloride, they continue with 2 weeks using artificial tears (Systane)

Drug: Autologous serum - Systane

Systane- Autologous serum

OTHER

Crossover arm starting with artificial tears (Systane) for 2 weeks. After a 1 week wash out with 0.9% sodium chloride, they continue with 2 weeks using autologous serum.

Drug: Systane - Autologous serum

Interventions

Autologous serum - Systane DRUG

20% autologous serum solution used four times a day for two weeks. Then 0.9% sodium chloride four times a day for one week. Finally, Systane (r) four times a day for two weeks.

Autologous serum -Systane

Systane - Autologous serum DRUG

Systane (r) four times a day for two weeks. Then 0.9% sodium chloride used four times a day for one weeks. Finally, 20% autologous serum solution four times a day for two week.

Systane- Autologous serum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Severe Dry Eye, as defined by a OSDI score \> or = 40
• Plus:
• Tear Break Up Time (TBUT) \< 5 seconds
• Cornea-conjunctival epithelial defects measured by Fluorescein staining and evaluation using the Oxford score.

You may not qualify if:

• No dry eye associated ocular disease
• Unable to comply protocol
• Severe anemia
• Previous use of autologous serum
• Concomitant use of other topical ocular drug
• Hypersensibility to any proposed interventions

Sponsors & Collaborators

• University of Chile: lead

Study Sites (1)

University Of Chile Clinical Hospital

Santiago, Santiago Metropolitan, Chile

Location

Related Publications (1)

• Urzua CA, Vasquez DH, Huidobro A, Hernandez H, Alfaro J. Randomized double-blind clinical trial of autologous serum versus artificial tears in dry eye syndrome. Curr Eye Res. 2012 Aug;37(8):684-8. doi: 10.3109/02713683.2012.674609. Epub 2012 Jun 6.

  PMID: 22670856 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Cristhian A Urzua, MD

  University of Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 22, 2008
• First Posted: October 24, 2008
• Study Start: October 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: December 3, 2008

Record last verified: 2008-10

Locations

CL (1)