Efficacy, Tolerability, and Comfort of 0.3% Hypromellose Eyedrops in Patients Undergoing LASIK Surgery

Dry Eye Clinical Trial

Official title:

Efficacy, Tolerability and Comfort of 0.3% Hypromellose Eyedrops in the Pre- and Post-Operative Treatment of Patients Undergoing LASIK Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00909324
• Other study ID #: CGET980AIN03
• Status: Completed
• Phase: Phase 4
• Start date: August 1, 2009
• Est. completion date: January 1, 2010

Study information

• Verified date: July 2020
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to assess the tolerability and comfort of peri-operative 0.3% hypromellose eye drops in LASIK surgery patients and to assess whether pre-operative 0.3% hypromellose eye drops add to post-operative comfort in LASIK surgery patients compared to control (no pre-operative lubricant).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: January 1, 2010
• Est. primary completion date: January 1, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 35 Years

Eligibility

Inclusion Criteria:

• Age 21 - 35

• Both sexes

• Seeking LASIK surgery at the Refractive Surgery Centre

• Meeting all established criteria for appropriateness for LASIK established by the treating center

Exclusion Criteria:

• Any corneal pathology including scars, prior herpes keratitis, prior corneal transplant

• Any immuno-compromised state including cancer, HIV infection, Hepatitis B or C, or diabetes mellitus

• Requirement for any eye-drops for any reason (eg, dry eye or conjunctivitis) within 3 months from time of enrollment

• Anticipated refusal or inability to undergo planned post-operative visits or assessment

• Failure to meet all established criteria for appropriateness for LASIK

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Pre-LASIK 0.3% hypromellose
Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.
• Post-LASIK 0.3% hypromellose
Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.

Locations

Country	Name	City	State
India	Novartis Investigative Site	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular Comfort Level From Baseline to End of Study	Patients rated their ocular comfort on a scale of 0 to 10 on the following parameters: Burning sensation, foreign body sensation, itching, watering of eyes, dryness of eyes, and photophobia. A higher score indicated greater discomfort. A negative change score indicated improvement.	Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery
Secondary	Tear Breakup Time From Baseline to End of Study	The time required for dry spots to appear on the corneal surface after blinking. Sodium fluorescein dye is added to the eye and the tear film is observed under a slit lamp while the patient avoids blinking until tiny dry spots develop. The longer it takes, the more stable the tear film. A short tear breakup time is a sign of a poor tear film. Generally, >10 seconds is thought to be normal, 5 to 10 seconds marginal, and <5 seconds low (with high likelihood of dry eye symptoms), ie, a shorter time indicates greater eye dryness. A positive change score indicates improvement.	Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery
Secondary	Results of Schirmer's Test From Baseline to End of Study	Schirmer's test determines tear production, and whether the eye produces enough tears to keep it moist. A small strip of filter paper is inserted inside the lower eyelid of each eye and the eyes are closed for 5 minutes. The paper is then removed and the length of paper that is moist is measured. A young person normally moistens 15 mm of the paper. The shorter the length of moist paper, the dryer the eyes. A positive change score indicates improvement.	Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery