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

Phase 4

Completed

• Conditions: Dry Eye
• Interventions: Drug: Pre-LASIK 0.3% hypromellose; Drug: Post-LASIK 0.3% hypromellose

• Registration Number: NCT00909324
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-05-26
• Study First Submitted QC: 2009-05-26
• Study First Posted: 2009-05-28
• Study Start: 2009-08-01
• Primary Completion: 2010-01-01
• Study Completion: 2010-01-01
• Results First Submitted: 2011-01-12
• Results First Submitted QC: 2011-02-24
• Results First Posted: 2011-03-24
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-30
• Last Update Posted: 2020-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre-LASIK 0.3% hypromellose	Pre-LASIK 0.3% hypromellose	-
Post-LASIK 0.3% hypromellose	Post-LASIK 0.3% hypromellose	-

Primary Outcome Measures

Name	Time	Method
Ocular Comfort Level From Baseline to End of Study	Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery	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.

Secondary Outcome Measures

Name	Time	Method
Results of Schirmer's Test From Baseline to End of Study	Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery	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.
Tear Breakup Time From Baseline to End of Study	Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery	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.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇮🇳 Delhi, India