Hydroxypropylmethylcellulose 0.3% and Sodium Hyaluronate 0.18% for Ocular Surface Disease in Glaucoma

• Sponsor: Mahidol University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01284439
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Duration (Months): 13
• Patients Per Site Per Month: 9.2

Study Details

Study Description

Brief Summary

To study effect of hydroxypropylmethylcellulose 0.3% and sodium hyaluronate 0.18% in the treatment of ocular surface disease in glaucoma patients.

Condition or Disease	Intervention/Treatment	Phase
Ocular Surface Disease; Glaucoma	Drug: hydroxypropylmethylcellulose; Drug: sodium hyaluronate	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Hydroxypropylmethylcellulose 0.3% and Sodium Hyaluronate 0.18% in the Treatment of Ocular Surface Disease in Glaucoma Patients
• Study Start Date: Jan 1, 2011
• Anticipated Primary Completion Date: Jan 1, 2012
• Anticipated Study Completion Date: Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TearA	Drug: hydroxypropylmethylcellulose; TearA: QID to every 2 hous , 1-2 drops per each time , duration 1 month
Experimental: TearB	Drug: sodium hyaluronate; QID to every 2 hous, 1-2 drops per each time, duration 1 month

Outcome Measures

Primary Outcome Measures

1. Ocular surface index score [1 month]

Secondary Outcome Measures

1. Eye lid inflammation, corneal staining score, tear break up time and tear volume [1 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• OSDI > or equal 20 and eye lid inflammation , meibomian gland inflammation,conjunctival injection,follicle at tarsus , positive corneal staining , tear break up time less than 8 seconds , tear volume less than 5.5 mm.

Exclusion Criteria:

• Age below 18 yo

• Active infectious corneal disease

• Post penetrating keratoplasty or glaucoma drainage device

• Known allergy to medication

• Lactation , Pregnant

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Ophthalmology , Siriraj Hospital	Bangkok		Thailand

Sponsors and Collaborators

• Mahidol University

Investigators

• Principal Investigator: AssocProf Pinnita Tanthuvanit, MD, Mahidol University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01284439
• Other Study ID Numbers: 655/2553(EC4)
• First Posted: Jan 27, 2011
• Last Update Posted: Jan 27, 2011
• Last Verified: Jan 1, 2011

• Additional relevant MeSH terms: Glaucoma; Hyaluronic Acid

Study Results

No Results Posted as of Jan 27, 2011