Elsevier

Ophthalmology

Volume 110, Issue 12, December 2003, Pages 2327-2334
Ophthalmology

Comparison of adverse events with daily disposable hydrogels and spectacle wear: results from a 12-month prospective clinical trial

https://doi.org/10.1016/S0161-6420(03)00795-4Get rights and content

Abstract

Objective

To evaluate the type and incidence of adverse events seen with daily disposable hydrogel contact lens wear compared with a control (spectacle) group over 12 months.

Design

Prospective, randomized, observer-masked, comparative clinical trial.

Participants

Two hundred eighty-one myopes with no prior contact lens wear experience were enrolled from August to December 1996. Subjects were 16 to 35 years old and had refractive errors ranging from a −0.75-diopter (D) sphere to a −6.00-D sphere with a cylinder less than −1.00 D.

Intervention

Each subject was randomly assigned to wear either bilateral disposable hydrogels on a daily disposable wear schedule or spectacles.

Main outcome measure

Type and incidence of adverse events from each group. Adverse events were categorized as serious, significant, and nonsignificant based on the potential to cause vision impairment, severity at event, and level of clinical concern.

Results

At baseline, 1.6% of eyes had asymptomatic infiltrates that were nonsignificant. During the study, asymptomatic infiltrates were seen in both contact lens and spectacle groups at 20.5 events versus 11.3 events per 100 eyes per year of wear. No significant events were seen with the spectacle group. With the contact lens group, the type and incidence of significant events per 100 eyes per year of lens wear were corneal peripheral ulcer, 2.5 events; infiltrative keratitis, 1.5 events; and papillary conjunctivitis, 1 event. The incidence of both significant and nonsignificant events was greater with the contact lens group (P<0.05). No serious events (i.e., microbial keratitis) were seen in either group. A greater number of subjects were lost to follow-up or permanently discontinued from the contact lens group relative to the spectacle group (33% vs. 17%, P = 0.002). Lens-related problems such as dryness, discomfort, and difficulty with insertion and removal accounted for 27% of discontinuations from the contact lens group. Poor compliance (40%) was the greatest reason for discontinuations from the spectacle group.

Conclusions

No clinically serious events were seen with either group. Only a small percentage of contact lens–wearing eyes presented with significant events, which is promising for daily disposable lens wear. Far more contact lens subjects were lost to follow-up or discontinued. Small, asymptomatic, subepithelial corneal infiltrates of unknown significance were seen in both contact lens– and spectacle-wearing eyes.

Section snippets

Study population

The subjects for the study were residents of Hyderabad, Andhra Pradesh, India. A total of 281 eligible subjects with no prior contact lens wear experience were enrolled in the study from August to December 1996. Subjects were randomized to either contact lens– or spectacle-wearing groups using a computer-generated random allocation table. Subjects were 16 to 35 years old; had refractive errors ranging from a −0.75-diopter (D) sphere to a −6.00 diopter (D) sphere, with a cylindrical component

Demographic data and trial profile

Two hundred eighty-one subjects were enrolled in the study, which commenced in August 1996. One hundred thirty-nine subjects were randomized to the contact lens group and 142 to the spectacle group. The study was completed in September 1997. The demographic data for the spectacle and contact lens groups are presented in Table 2.

Ninety-three of the 139 contact lens subjects (67%) and 118 of the 142 spectacle subjects (83%) completed 12 months in the study. Figure 1 depicts the trial profile

Discussion

Spectacle wear represents a benchmark from which to assess the performance of contact lens wear. Our prospective clinical trial showed that although the incidence of adverse events with daily disposable lens wear was low, the incidence was greater than that with spectacle wear. All significant adverse events were seen with daily disposable lens wear, and the majority of these were corneal infiltrative events. An earlier study conducted at the same center found that the incidence of corneal

References (13)

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Supported in part by Vistakon, Johnson & Johnson, Jacksonville, Florida; Hyderabad Eye Research Foundation, India; Optometric Vision Research Foundation, Australia; and the Australian Federal Government through the Cooperative Research Centres Program.

Manuscript no. 210715.

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